Trial Outcomes & Findings for Avelumab in First-line NSCLC (JAVELIN Lung 100) (NCT NCT02576574)

Last Updated: 2025-01-31

Results Overview

PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1214 participants

Primary outcome timeframe

Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Results posted on

2025-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	Avelumab Biweekly Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Avelumab Weekly Participants received Avelumab at a dose of 10 mg/kg as a 1-hour (-10/+20 minutes) IV infusion every week for 12 consecutive weeks, followed by Avelumab at a dose of 10 mg/kg once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Overall Study STARTED	366	322	526
Overall Study COMPLETED	366	322	526
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Avelumab in First-line NSCLC (JAVELIN Lung 100)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Avelumab Biweekly n=366 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Avelumab Weekly n=322 Participants Participants received Avelumab at a dose of 10 mg/kg as a 1-hour (-10/+20 minutes) IV infusion every week for 12 consecutive weeks, followed by Avelumab at a dose of 10 mg/kg once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=526 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Total n=1214 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	190 Participants n=5 Participants	168 Participants n=7 Participants	289 Participants n=5 Participants	647 Participants n=4 Participants
Age, Categorical >=65 years	176 Participants n=5 Participants	154 Participants n=7 Participants	237 Participants n=5 Participants	567 Participants n=4 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	69 Participants n=7 Participants	145 Participants n=5 Participants	298 Participants n=4 Participants
Sex: Female, Male Male	282 Participants n=5 Participants	253 Participants n=7 Participants	381 Participants n=5 Participants	916 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants	72 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	338 Participants n=5 Participants	296 Participants n=7 Participants	466 Participants n=5 Participants	1100 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	6 Participants n=7 Participants	22 Participants n=5 Participants	42 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	85 Participants n=5 Participants	53 Participants n=7 Participants	104 Participants n=5 Participants	242 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	254 Participants n=5 Participants	250 Participants n=7 Participants	375 Participants n=5 Participants	879 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	17 Participants n=7 Participants	43 Participants n=5 Participants	85 Participants n=4 Participants

PRIMARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: High PD-L1+ FAS included all high expression PD-L1+ participants who were randomized to study intervention. High expression PD-L1+ participants with greater than or equal to (\>=) 80 percent (%) of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=151 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=216 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)	8.4 months Interval 5.4 to 12.6	5.6 months Interval 5.4 to 6.8	—

PRIMARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: High PD-L1+ mFAS included all high expression PD-L1+ participants who were randomized to study intervention after weekly Avelumab was included into the randomization allocation. The PDL1+ participants with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=130 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=129 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Modified Full Analysis Set (mFAS)	7.5 months Interval 4.2 to 11.1	5.6 months Interval 5.0 to 6.8	—

PRIMARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=151 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=216 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)	20.1 months Interval 15.0 to 24.3	14.9 months Interval 11.8 to 18.6	—

PRIMARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=130 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=129 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)	19.3 months Interval 14.0 to 28.1	15.3 months Interval 11.6 to 19.1	—

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: Moderate and High PD-L1+ FAS included all high expression PDL-L1+ participants who were randomized to study intervention. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=218 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=304 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)	6.9 months Interval 5.4 to 9.6	5.6 months Interval 5.5 to 6.6	—

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: Moderate and High PD-L1+ mFAS included all high expression PD-L1+ participants who were randomized to study intervention after weekly avelumab was included into the randomization allocation. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=183 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=183 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)	5.6 months Interval 2.8 to 8.2	5.6 months Interval 5.5 to 6.6	—

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: Moderate and High PD-L1+ FAS included all high expression PD-L1+ participants who were randomized to study intervention. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=218 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=304 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)	18.7 months Interval 14.6 to 21.7	13.3 months Interval 11.4 to 16.6	—

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=183 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=183 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)	16.8 months Interval 12.5 to 21.3	13.0 months Interval 11.1 to 17.0	—

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: FAS included all participants who were randomized to study intervention.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=366 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=526 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Overall Survival (OS) in Full Analysis Set (FAS)	15.0 months Interval 12.5 to 19.1	14.3 months Interval 11.8 to 15.6	—

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: mFAS included all participants who were randomized to study intervention after weekly avelumab was included into the randomization allocation.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=322 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=321 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Overall Survival (OS) in Modified Full Analysis Set (mFAS)	15.4 months Interval 12.1 to 18.1	14.8 months Interval 11.6 to 16.4	—

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=151 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=216 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Full Analysis Set	37.7 percentage of participants Interval 30.0 to 46.0	30.1 percentage of participants Interval 24.1 to 36.7	—

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=130 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=129 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Modified Full Analysis Set	34.6 percentage of participants Interval 26.5 to 43.5	30.2 percentage of participants Interval 22.5 to 38.9	—

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=218 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=304 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in Moderate and High PD-L1+ Full Analysis Set	33.5 percentage of participants Interval 27.3 to 40.2	30.3 percentage of participants Interval 25.1 to 35.8	—

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=183 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=183 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in Moderate and High PD-L1+ Modified Full Analysis Set	30.6 percentage of participants Interval 24.0 to 37.8	30.6 percentage of participants Interval 24.0 to 37.8	—

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: High PD-L1+ FAS was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=57 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=65 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)	35.9 months Interval 1.4 to 60.8	8.4 months Interval 1.0 to 63.9	—

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: High PD-L1+ mFAS was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=45 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=39 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)	19.4 months Interval 3.8 to 43.9	8.4 months Interval 1.0 to 35.9	—

SECONDARY outcome

Timeframe: Baseline, End of treatment (up to Week 283.9)

Population: High PD-L1+HRQoL analysis set includes all high expression PD-L1+ FAS participants who have 1 baseline HRQoL assessment and have \>=1 post-baseline HRQoL questionnaire complete. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=56 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=107 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High PD-L1+ Health-related Quality of Life (HRQoL) Analysis Set at End of Treatment	-6.2 millimeter (mm) Standard Deviation 23.61	-5.2 millimeter (mm) Standard Deviation 20.48	—

SECONDARY outcome

Timeframe: Baseline, End of treatment (Week 283.9)

Population: High PD-L1+ Modified HRQoL Analysis Set included all mFAS participants who have 1 baseline HRQoL assessment and have \>=1 post-baseline HRQoL questionnaire completed. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=53 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=70 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set	-10.3 millimeter Standard Deviation 22.49	-3.9 millimeter Standard Deviation 20.21	—

SECONDARY outcome

Timeframe: Baseline, End of treatment (up to Week 283.9)

Population: High PD-L1+HRQoL analysis set includes all high expression PD-L1 FAS participants who have 1 baseline HRQoL assessment and have \>=1 post-baseline HRQoL questionnaire complete. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=56 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=108 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set	-0.3 score on a scale Standard Deviation 22.30	-6.1 score on a scale Standard Deviation 24.55	—

SECONDARY outcome

Timeframe: Baseline, End of treatment (Week 283.9)

Population: High PD-L1+modified HRQoL analysis set includes all high expression PD-l1+ mFAS participants who have 1 baseline HRQoL assessment and have ≥1 post-baseline HRQoL questionnaire completed. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=53 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=71 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set	-12.9 score on a scale Standard Deviation 21.03	-4.5 score on a scale Standard Deviation 23.30	—

SECONDARY outcome

Timeframe: Baseline, End of treatment (up to Week 283.9)

Population: High PD-L1+ HRQoL analysis set includes all high expression PD-L1+ FAS participants who have 1 baseline HRQoL assessment and have \>=1 post-baseline HRQoL questionnaire complete. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=56 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=108 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set Dyspnea	7.3 score on a scale Standard Deviation 24.10	5.2 score on a scale Standard Deviation 19.66	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set Coughing	2.4 score on a scale Standard Deviation 29.04	-4.3 score on a scale Standard Deviation 27.01	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set Hemoptysis	-1.8 score on a scale Standard Deviation 21.48	1.5 score on a scale Standard Deviation 13.95	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set Sore mouth	3.0 score on a scale Standard Deviation 18.28	1.9 score on a scale Standard Deviation 21.77	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set Dysphagia	3.0 score on a scale Standard Deviation 19.36	-0.6 score on a scale Standard Deviation 21.36	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set Peripheral neuropathy	3.6 score on a scale Standard Deviation 17.60	10.8 score on a scale Standard Deviation 24.46	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set Alopecia	0.0 score on a scale Standard Deviation 8.98	14.2 score on a scale Standard Deviation 32.93	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set Pain in chest	-4.2 score on a scale Standard Deviation 22.96	-1.5 score on a scale Standard Deviation 26.33	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set Pain in arm or shoulder	0.6 score on a scale Standard Deviation 32.71	1.9 score on a scale Standard Deviation 26.50	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set Pain in other parts	1.8 score on a scale Standard Deviation 33.29	1.5 score on a scale Standard Deviation 30.36	—

SECONDARY outcome

Timeframe: Baseline, End of treatment (up to Week 283.9)

Population: High PD-L1+ modified HRQoL analysis set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for specified categories.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=53 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=71 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set Dyspnea	6.1 score on a scale Standard Deviation 27.19	4.9 score on a scale Standard Deviation 18.77	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set Coughing	-0.6 score on a scale Standard Deviation 28.87	-5.2 score on a scale Standard Deviation 24.34	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set Hemoptysis	-0.6 score on a scale Standard Deviation 17.89	0.0 score on a scale Standard Deviation 12.59	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set Sore mouth	0.6 score on a scale Standard Deviation 13.97	1.9 score on a scale Standard Deviation 17.71	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set Dysphagia	3.8 score on a scale Standard Deviation 14.10	-0.5 score on a scale Standard Deviation 22.88	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set Peripheral neuropathy	0.6 score on a scale Standard Deviation 21.17	9.9 score on a scale Standard Deviation 23.49	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set Alopecia	-2.5 score on a scale Standard Deviation 17.11	15.0 score on a scale Standard Deviation 29.70	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set Pain in chest	2.5 score on a scale Standard Deviation 29.13	-0.5 score on a scale Standard Deviation 25.50	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set Pain in arm or shoulder	4.4 score on a scale Standard Deviation 30.69	1.4 score on a scale Standard Deviation 25.46	—
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set Pain in other parts	10.1 score on a scale Standard Deviation 28.93	1.4 score on a scale Standard Deviation 28.97	—

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAEs were those events with onset dates occurring during the on-treatment period or if the worsening of an event is during the on-treatment period TEAEs included both serious TEAEs and non-serious TEAEs. Any AE that was suspicious to be a potential Immune-related adverse event (irAE) including infusion related reactions were considered AESIs. Number of participants with TEAEs and AESIs were reported.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=361 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=318 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy n=500 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and AEs of Special Interest (AESIs) TEAEs	346 Participants	308 Participants	484 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and AEs of Special Interest (AESIs) AESIs	158 Participants	160 Participants	173 Participants

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

Number of participants with shifts from Baseline values (Grade 0/1/2/3) to abnormal post-baseline values (shift to \>= Grade 4) were reported as per NCI-CTCAE, v4.03 graded from Grade 1 to 5. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death. Shifts in laboratory parameter (anemia, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, white blood cell count decreased, alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase increased, creatinine increased and Hyperglycemia) were reported.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=361 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=318 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy n=500 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Alkaline phosphatase increased: Grade 1 to Grade 4	0 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Alkaline phosphatase increased: Grade 2 to Grade 3	0 Participants	1 Participants	0 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Aspartate aminotransferase increased: Grade 0 to Grade 3	7 Participants	4 Participants	3 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Aspartate aminotransferase increased: Grade 0 to Grade 4	1 Participants	2 Participants	2 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Aspartate aminotransferase increased: Grade 1 to Grade 3	0 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Blood bilirubin increased: Grade 0 to Grade 3	0 Participants	4 Participants	3 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Blood bilirubin increased: Grade 0 to Grade 4	0 Participants	1 Participants	0 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Creatine phosphokinase increased: Grade 0 to Grade 3	6 Participants	5 Participants	1 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Creatine phosphokinase increased: Grade 0 to Grade 4	5 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Creatine phosphokinase increased: Grade 1 to Grade 4	0 Participants	1 Participants	0 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Creatine phosphokinase increased: Grade 2 to Grade 3	0 Participants	1 Participants	0 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Creatinine increased: Grade 0 to Grade 3	6 Participants	4 Participants	4 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Creatinine increased: Grade 1 to Grade 3	0 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Hyperglycemia: Grade 0 to Grade 3	21 Participants	20 Participants	35 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Hyperglycemia: Grade 0 to Grade 4	0 Participants	0 Participants	3 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Anemia: Grade 0 to Grade 3	4 Participants	2 Participants	58 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Anemia: Grade 1 to Grade 3	4 Participants	5 Participants	30 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Anemia: Grade 2 to Grade 3	4 Participants	6 Participants	6 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Lymphocyte count decreased: Grade 2 to Grade 4	0 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Lymphocyte count decreased: Grade 0 to Grade 3	16 Participants	15 Participants	31 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Lymphocyte count decreased: Grade 0 to Grade 4	1 Participants	2 Participants	3 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Lymphocyte count decreased: Grade 1 to Grade 3	2 Participants	10 Participants	12 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Lymphocyte count decreased: Grade 2 to Grade 3	7 Participants	6 Participants	12 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Lymphocyte count decreased: Grade 3 to Grade 4	0 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Neutrophil count decreased: Grade 0 to Grade 3	4 Participants	4 Participants	65 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Neutrophil count decreased: Grade 0 to Grade 4	0 Participants	3 Participants	25 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Neutrophil count decreased: Grade 1 to Grade 3	1 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Platelet count decreased: Grade 0 to Grade 3	0 Participants	1 Participants	18 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Platelet count decreased: Grade 0 to Grade 4	0 Participants	3 Participants	20 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Platelet count decreased: Grade 1 to Grade 3	0 Participants	1 Participants	0 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 White blood cell count decreased: Grade 0 to Grade 3	0 Participants	3 Participants	24 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 White blood cell count decreased: Grade 0 to Grade 4	0 Participants	1 Participants	11 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Alanine aminotransferase increased: Grade 0 to Grade 3	12 Participants	8 Participants	5 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Alanine aminotransferase increased: Grade 0 to Grade 4	1 Participants	1 Participants	3 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Alanine aminotransferase increased: Grade 1 to Grade 3	1 Participants	0 Participants	2 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Alkaline phosphatase increased: Grade 0 to Grade 3	0 Participants	3 Participants	1 Participants
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Alkaline phosphatase increased: Grade 1 to Grade 3	1 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

The number of participants with changes from baseline in increased Body Temperature (degree Celsius \[°C\]) were reported by using criteria: Baseline temperature (temp.) less than (\<) 37°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, greater than or equal to (\>=)3°C and missing; Baseline temp. 37 - \<38°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. 38 - \<39°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. 39-\<40°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. \>=40°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. missing, on treatment change missing.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=361 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=318 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy n=500 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 37 - <38°C, on treatment change missing	1 Participants	0 Participants	3 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. <37°C, on treatment change <1°C	271 Participants	256 Participants	403 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp.<37°C, on treatment change 1 - <2°C	45 Participants	32 Participants	33 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. <37°C, on treatment change 2 - <3°C	3 Participants	2 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. <37°C, on treatment change >=3°C	0 Participants	1 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. <37°C, on treatment change missing	16 Participants	6 Participants	21 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 37 - <38°C, on treatment change <1°C	23 Participants	19 Participants	37 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 37 - <38°C, on treatment change 1 - <2°C	1 Participants	2 Participants	1 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 37 - <38°C, on treatment change 2 - <3°C	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 37 - <38°C, on treatment change >=3°C	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. missing, on treatment change missing	0 Participants	0 Participants	2 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 38 - <39°C, on treatment change <1°C	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 38 - <39°C, on treatment change 1 - <2°C	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 38 - <39°C, on treatment change 2 - <3°C	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 38 - <39°C, on treatment change >=3°C	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 38 - <39°C, on treatment change missing	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 39 - <40°C, on treatment change <1°C	1 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 39 - <40°C, on treatment change 1 - <2°C	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 39 - <40°C, on treatment change 2 - <3°C	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 39 - <40°C, on treatment change >=3°C	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. 39 - <40°C, on treatment change missing	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. >=40°C, on treatment change <1°C	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. >=40°C, on treatment change 1 - <2°C	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. >=40°C, on treatment change 2 - <3°C	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. >=40°C, on treatment change >=3°C	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase Baseline temp. >=40°C, on treatment change missing	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

The number of participants with maximal on-treatment changes from baseline in Increase (Ic.)/Decrease (Dc.) in maximal weight were reported by using criteria: Ic./Dc. From baseline, on treatment (TR) change \<10 percentage (%), \>=10% and missing.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=361 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=318 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy n=500 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Weight Increase/Decrease Ic. from baseline, on TR change <10%	302 Participants	280 Participants	436 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Weight Increase/Decrease Ic. from baseline, on TR change >=10%	38 Participants	28 Participants	39 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Weight Increase/Decrease Ic. from baseline, on TR change missing	21 Participants	10 Participants	25 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Weight Increase/Decrease Dc. from baseline, on TR change <10%	296 Participants	258 Participants	423 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Weight Increase/Decrease Dc. from baseline, on TR change >=10%	44 Participants	50 Participants	52 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Weight Increase/Decrease Dc. from baseline, on TR change missing	21 Participants	10 Participants	25 Participants

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

The number of participants with maximal on-treatment (TR) changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) heart rate (HR) (beats per minute \[bpm\]) were reported by using criteria: Ic./Dc. BS HR \<100/\>=100 bpm, on treatment change =\<20 bpm, \>20 - =\<40 bpm, \>40 bpm and missing; Ic./Dc. BS HR missing, on treatment change missing.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=361 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=318 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy n=500 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Ic. BS HR <100 bpm, on TR change =<20 bpm	206 Participants	202 Participants	332 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Ic. BS HR <100 bpm, on TR change >20 - =<40 bpm	86 Participants	66 Participants	85 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Ic. BS HR <100 bpm, on TR change >40 bpm	21 Participants	12 Participants	9 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Ic. BS HR <100 bpm, on TR change missing	14 Participants	5 Participants	16 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Ic. BS HR >= 100 bpm, on TR change =<20 bpm	31 Participants	30 Participants	46 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Ic. BS HR >= 100 bpm, on TR change >20 - =<40 bpm	0 Participants	2 Participants	3 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Ic. BS HR >= 100 bpm, on TR change >40 bpm	0 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Ic. BS HR >= 100 bpm, on TR change missing	3 Participants	1 Participants	7 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Ic. BS HR missing, on TR change missing	0 Participants	0 Participants	2 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Dc. BS HR <100 bpm, on TR change =<20 bpm	267 Participants	227 Participants	385 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Dc. BS HR <100 bpm, on TR change >20 - =<40 bpm	44 Participants	52 Participants	40 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Dc. BS HR <100 bpm, on TR change >40 bpm	2 Participants	1 Participants	1 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Dc. BS HR <100 bpm, on TR change missing	14 Participants	5 Participants	16 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Dc. BS HR >= 100 bpm, on TR change =<20 bpm	14 Participants	13 Participants	20 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Dc. BS HR >= 100 bpm, on TR change >20 - =<40 bpm	6 Participants	12 Participants	26 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Dc. BS HR >= 100 bpm, on TR change >40 bpm	11 Participants	7 Participants	3 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Dc. BS HR >= 100 bpm, on TR change missing	3 Participants	1 Participants	7 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease Dc. BS HR missing, on TR change missing	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

The number of participants with maximal on-treatment changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) Systolic Blood Pressure (SBP) and diastolic blood pressure (DBP) (millimeter of mercury \[mmHg\]) were reported by using criteria: Ic./Dc. BS SBP \<140 mmHg and \>=140 mmHg, on maximal treatment (TR) change =\<20 mmHg, \>20 - =\<40 mmHg, \>40 mmHg and missing; Ic./Dc. BS SBP missing, on maximal treatment (TR) change missing; Ic./Dc. BS DBP \<90 mmHg and \>= 90 mmHg, on maximal TR change =\<20 mmHg, \>20 - =\<40 mmHg, \>40 mmHg and missing; Ic./Dc. BS DBP missing on maximal TR change missing.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=361 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=318 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy n=500 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS SBP <140 mmHg, on TR change =<20 mmHg	219 Participants	209 Participants	278 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS SBP <140 mmHg, on TR change >20 - =<40 mmHg	61 Participants	56 Participants	104 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS SBP <140 mmHg, on TR change >40 mmHg	16 Participants	16 Participants	10 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS SBP <140 mmHg, on TR change missing	14 Participants	4 Participants	21 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS SBP >=140 mmHg, on TR change =<20 mmHg	41 Participants	26 Participants	78 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS SBP >=140 mmHg, on TR change >20 - =<40 mmHg	7 Participants	5 Participants	5 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS SBP >=140 mmHg, on TR change >40 mmHg	0 Participants	0 Participants	1 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS SBP > = 140 mmHg, on TR change missing	3 Participants	2 Participants	2 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS SBP missing, on TR change missing	0 Participants	0 Participants	1 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS SBP <140 mmHg, on TR change =<20 mmHg	220 Participants	204 Participants	322 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS SBP <140 mmHg, on TR change >20 - =<40 mmHg	70 Participants	70 Participants	69 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS SBP <140 mmHg, on TR change >40 mmHg	6 Participants	7 Participants	1 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS SBP <140 mmHg, on TR change missing	14 Participants	4 Participants	21 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS SBP >=140 mmHg, on TR change =<20 mmHg	11 Participants	6 Participants	32 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS SBP >=140 mmHg, on TR change >20 - =<40 mmHg	25 Participants	15 Participants	34 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS SBP >=140 mmHg, on TR change >40 mmHg	12 Participants	10 Participants	18 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS SBP > = 140 mmHg, on TR change missing	3 Participants	2 Participants	2 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS SBP missing, on TR change missing	0 Participants	0 Participants	1 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS DBP <90 mmHg, on TR change =<20 mmHg	272 Participants	260 Participants	402 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS DBP <90 mmHg, on TR change >20 - =<40 mmHg	48 Participants	37 Participants	45 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS DBP <90 mmHg, on TR change >40 mmHg	0 Participants	1 Participants	1 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS DBP <90 mmHg, on TR change missing	17 Participants	5 Participants	23 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS DBP missing, on TR change missing	0 Participants	0 Participants	1 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS DBP >=90 mmHg, on TR change =<20 mmHg	24 Participants	12 Participants	28 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS DBP >=90 mmHg, on TR change >20 - =<40 mmHg	0 Participants	1 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS DBP >=90 mmHg, on TR change >40 mmHg	0 Participants	1 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Ic. BS DBP >=90 mmHg, on TR change missing	0 Participants	1 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS DBP <90 mmHg, on TR change =<20 mmHg	279 Participants	264 Participants	415 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS DBP <90 mmHg, on TR change >20 - =<40 mmHg	38 Participants	33 Participants	32 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS DBP <90 mmHg, on TR change >40 mmHg	3 Participants	1 Participants	1 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS DBP <90 mmHg, on TR change missing	17 Participants	5 Participants	23 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS DBP >=90 mmHg, on TR change =<20 mmHg	11 Participants	5 Participants	18 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS DBP >=90 mmHg,on TR change >20 - =<40 mmHg	12 Participants	9 Participants	10 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS DBP >=90 mmHg, on TR change >40 mmHg	1 Participants	0 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS DBP >=90 mmHg, on TR change missing	0 Participants	1 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease Dc. BS DBP missing, on TR change missing	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

The number of participants with maximal on-treatment (TR) changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) maximal Respiration Rate (RR) were reported by using criteria: Ic./Dc. BS RR \<20 breaths per minute (breaths/min), on TR change =\<5 breaths/min, \>5 - =\<10 breaths/min, \>10 breaths/min and missing. Ic./Dc. BS RR missing, on TR change missing. Ic./Dc. BS RR \>=20 breaths/min, on TR change =\<5 breaths/min, \>5 - =\<10 breaths/min, \>10 breaths/min and missing.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=361 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=318 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy n=500 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Ic. BS RR <20 breaths/min, on TR change =<5 breaths/min	221 Participants	224 Participants	306 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Ic.BS RR<20 breaths/min, on TR change >5 - = <10 breaths/min	18 Participants	13 Participants	26 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Ic. BS RR <20 breaths/min, on TR change >10 breaths/min	1 Participants	1 Participants	2 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Ic. BS RR <20 breaths/min, on TR change missing	11 Participants	4 Participants	14 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Ic. BS RR >=20 breaths/min, on TR change =<5 breaths/min	89 Participants	68 Participants	124 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Ic.BS RR >=20 breaths/min, on TR change >5 - =<10 breaths/min	5 Participants	4 Participants	2 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Ic. BS RR >=20 breaths/min, on TR change >10 breaths/min	3 Participants	1 Participants	0 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Ic. BS RR >=20 breaths/min, on TR change missing	7 Participants	2 Participants	15 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Ic. BS RR missing, on TR change missing	6 Participants	1 Participants	11 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Dc. BS RR <20 breaths/min, on TR change =<5 breaths/min	232 Participants	236 Participants	325 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Dc. BS RR <20 breaths/min, on TR change >5 - =<10 breaths/min	8 Participants	2 Participants	8 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Dc. BS RR <20 breaths/min, on TR change >10 breaths/min	0 Participants	0 Participants	1 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Dc. BS RR <20 breaths/min, on TR change missing	11 Participants	4 Participants	14 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Dc. BS RR >=20 breaths/min, on TR ch =<5 breaths/min	79 Participants	58 Participants	101 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Dc.BS RR >=20 breaths/min, on TR change >5 - =<10 breaths/min	14 Participants	13 Participants	22 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Dc. BS RR >=20 breaths/min, on TR change >10 breaths/min	4 Participants	2 Participants	3 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Dc. BS RR >=20 breaths/min, on TR change missing	7 Participants	2 Participants	15 Participants
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease Dc. BS RR missing, on TR change missing	6 Participants	1 Participants	11 Participants

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

ECG parameters included heart rate, PR interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). PCSA criteria for abnormal value of ECG parameters: any heart rate \<= 50 bpm and decrease from baseline \>=20 bpm , any hear rate \>= 120 bpm and increase from baseline \>= 20 bpm; PR interval: \>= 220 milliseconds (ms) and increase from baseline \>= 20 ms; QRS interval \>= 120 ms; QTcF \> 450 ms, \> 480 ms, \> 500 ms, QTcF increase from baseline \> 30 ms and QTcF increase from baseline \> 60 ms; QTcB \> 450 ms, \> 480 ms, \> 500 ms, QTcB increase from baseline \> 30 ms and QTcB increase from baseline \> 60 ms.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=264 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=223 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy n=399 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters Heart Rate <= 50 bpm and decrease from baseline >= 20 bpm	1 Participants	1 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters Heart Rate >= 120 bpm and decrease from baseline >= 20 bpm	10 Participants	6 Participants	7 Participants
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters PR interval >= 220 ms and increase from baseline >= 20 ms	0 Participants	5 Participants	3 Participants
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters QRS interval >= 120 ms	18 Participants	10 Participants	15 Participants
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters QTcF > 450 ms	19 Participants	13 Participants	24 Participants
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters QTcF > 480 ms	5 Participants	4 Participants	11 Participants
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters QTcF > 500 ms	3 Participants	1 Participants	5 Participants
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters QTcF increase from baseline > 30 ms	20 Participants	12 Participants	39 Participants
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters QTcF increase from baseline > 60 ms	6 Participants	1 Participants	13 Participants
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters QTcB > 450 ms	49 Participants	31 Participants	70 Participants
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters QTcB > 480 ms	13 Participants	11 Participants	24 Participants
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters QTcB > 500 ms	6 Participants	5 Participants	16 Participants
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters QTcB increase from baseline > 30 ms	32 Participants	25 Participants	49 Participants
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters QTcB increase from baseline > 60 ms	11 Participants	7 Participants	19 Participants

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. ECOG performance status was reported in terms of number of participants with baseline value vs worst post-baseline value (that is \[i.e.\] highest score).

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=361 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=318 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy n=500 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 0	50 Participants	35 Participants	84 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 1	56 Participants	49 Participants	83 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 2	8 Participants	9 Participants	11 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 3	1 Participants	7 Participants	4 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 4	1 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score 5	0 Participants	0 Participants	1 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 0, worst post-baseline score Missing	6 Participants	4 Participants	4 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 0	1 Participants	2 Participants	4 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 1	168 Participants	153 Participants	233 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 2	35 Participants	32 Participants	46 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 3	16 Participants	18 Participants	6 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 4	3 Participants	1 Participants	4 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score 5	5 Participants	1 Participants	3 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score 1, worst post-baseline score Missing	10 Participants	6 Participants	16 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score >=2, worst post-baseline score 0	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score >=2, worst post-baseline score 1	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score >=2, worst post-baseline score 2	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score >=2, worst post-baseline score 3	1 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score >=2, worst post-baseline score 4	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score >=2, worst post-baseline score 5	0 Participants	1 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score >=2, worst post-baseline score missing	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score missing, worst post-baseline score 0	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score missing, worst post-baseline score 1	0 Participants	0 Participants	1 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score missing, worst post-baseline score 2	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score missing, worst post-baseline score 3	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score missing, worst post-baseline score 4	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score missing, worst post-baseline score 5	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score Baseline score missing, worst post-baseline score missing	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Population: The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported.

Outcome measures

Outcome measures
Measure	Avelumab Biweekly n=360 Participants Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.	Chemotherapy n=318 Participants Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.	Chemotherapy Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.
Number of Participants With At Least One Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab ADAs to Avelumab	66 Participants	38 Participants	—
Number of Participants With At Least One Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab NAbs to Avelumab	43 Participants	18 Participants	—

Adverse Events

Avelumab Biweekly

Serious events: 181 serious events

Other events: 331 other events

Deaths: 279 deaths

Avelumab Weekly

Serious events: 143 serious events

Other events: 298 other events

Deaths: 237 deaths

Chemotherapy

Serious events: 195 serious events

Other events: 474 other events

Deaths: 405 deaths

Serious adverse events

Other adverse events

Additional Information

Communication Center

Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER