Trial Outcomes & Findings for Phase III Study to Determine the Efficacy of Durvalumab in Combination With Chemotherapy in Completely Resected Stage II-III Non-small Cell Lung Cancer (NSCLC) (NCT NCT04385368)

Last Updated: 2024-08-30

Results Overview

DFS was defined as the time from the date of randomization until either of the following events, whichever occurred first: disease recurrence using Investigator RECIST 1.1 assessments (i.e., local or regional recurrence, distant recurrence, second primary NSCLC) or death from any cause.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

89 participants

Primary outcome timeframe

Every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or until primary DFS analysis, up to 33.28 months

Results posted on

2024-08-30

Participant Flow

This Phase III, multicenter, randomized, double-blind, placebo-controlled study was conducted in participants with completely resected stage II to III non-small cell lung cancer (NSCLC) at 63 sites across 25 countries from 17 July 2020 to 31 August 2023.

A total of 89 participants were randomized in a 1:1 ratio to durvalumab given concurrently with standard of care (SoC) chemotherapy followed by durvalumab monotherapy, or to a matched placebo given concurrently with SoC chemotherapy followed by placebo.

Participant milestones

Participant milestones
Measure	Durvalumab + SoC Participants received durvalumab 1500 milligrams (mg) via intravenous (IV) infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by durvalumab monotherapy continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (area under the serum drug concentration-time curve \[AUC\] 6) and paclitaxel 200 milligram per square meter (mg/m\^2) via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.	Placebo + SoC Participants received matching placebo via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by matching placebo continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.
Overall Study STARTED	45	44
Overall Study COMPLETED	33	36
Overall Study NOT COMPLETED	12	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Durvalumab + SoC Participants received durvalumab 1500 milligrams (mg) via intravenous (IV) infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by durvalumab monotherapy continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (area under the serum drug concentration-time curve \[AUC\] 6) and paclitaxel 200 milligram per square meter (mg/m\^2) via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.	Placebo + SoC Participants received matching placebo via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by matching placebo continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.
Overall Study Death	5	5
Overall Study Physician Decision	3	0
Overall Study Withdrawal by Subject	4	3

Baseline Characteristics

Phase III Study to Determine the Efficacy of Durvalumab in Combination With Chemotherapy in Completely Resected Stage II-III Non-small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Durvalumab + SoC n=45 Participants Participants received durvalumab 1500 mg via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by durvalumab monotherapy continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.	Placebo + SoC n=44 Participants Participants received matching placebo via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by matching placebo continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.	Total n=89 Participants Total of all reporting groups
Age, Continuous	65.5 years STANDARD_DEVIATION 8.78 • n=5 Participants	64.5 years STANDARD_DEVIATION 7.37 • n=7 Participants	65.0 years STANDARD_DEVIATION 8.08 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants	18 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized White	35 Participants n=5 Participants	22 Participants n=7 Participants	57 Participants n=5 Participants
Race/Ethnicity, Customized Not reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	40 Participants n=5 Participants	43 Participants n=7 Participants	83 Participants n=5 Participants
Race/Ethnicity, Customized Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or until primary DFS analysis, up to 33.28 months

Population: The FAS included all randomized participants.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC n=45 Participants Participants received durvalumab 1500 mg via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by durvalumab monotherapy continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.	Placebo + SoC n=44 Participants Participants received matching placebo via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by matching placebo continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.
Disease-free Survival (DFS) in FAS (Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors 1.1 [RECIST 1.1])	NA months Interval 14.062 to NA indicates that median and upper limit of confidence interval was not estimable due to insufficient number of participants with events at study closure and due to limited duration of follow-up.	NA months Interval 21.914 to NA indicates that median and upper limit of confidence interval was not estimable due to insufficient number of participants with events at study closure and due to limited duration of follow-up.

SECONDARY outcome

Timeframe: Every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or until primary DFS analysis, up to 33.28 months

Population: The MRD+ analysis set included all participants in the FAS who were MRD+, as determined by results from the post-surgical plasma sample based on the assay that was used at the time of randomization assay.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC n=12 Participants Participants received durvalumab 1500 mg via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by durvalumab monotherapy continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.	Placebo + SoC n=11 Participants Participants received matching placebo via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by matching placebo continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.
DFS in Minimal Residual Disease-positive (MRD+) Analysis Set (Using Investigator Assessments According to RECIST 1.1)	16.7 months Interval 2.661 to NA indicates that upper limit of confidence interval was not estimable due to insufficient number of participants with events at study closure and due to limited duration of follow-up.	NA months Interval 5.585 to NA indicates that median and upper limit of confidence interval were not estimable due to insufficient number of participants with events at study closure and due to limited duration of follow-up.

SECONDARY outcome

Timeframe: From the date of randomization until death due to any cause, up to 35 months

Population: The FAS included all randomized participants.

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC n=45 Participants Participants received durvalumab 1500 mg via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by durvalumab monotherapy continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.	Placebo + SoC n=44 Participants Participants received matching placebo via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by matching placebo continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.
OS in FAS	NA months NA indicates that median, upper and lower limit of confidence interval were not estimable due to insufficient number of participants with events at study closure and due to limited duration of follow-up.	NA months NA indicates that median, upper and lower limit of confidence interval were not estimable due to insufficient number of participants with events at study closure and due to limited duration of follow-up.

SECONDARY outcome

Timeframe: From the date of randomization until death due to any cause, up to 35 months

Outcome measures

Outcome measures
Measure	Durvalumab + SoC n=12 Participants Participants received durvalumab 1500 mg via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by durvalumab monotherapy continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.	Placebo + SoC n=11 Participants Participants received matching placebo via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by matching placebo continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.
Overall Survival (OS) in MRD+ Analysis Set	NA months Interval 9.331 to NA indicates that median and upper limit of confidence interval were not estimable due to insufficient number of participants with events at study closure and due to limited duration of follow-up.	NA months Interval 13.372 to NA indicates that median and upper limit of confidence interval were not estimable due to insufficient number of participants with events at study closure and due to limited duration of follow-up.

Adverse Events

Durvalumab + SoC

Serious events: 14 serious events

Other events: 43 other events

Deaths: 6 deaths

Placebo + SoC

Serious events: 10 serious events

Other events: 44 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Durvalumab + SoC n=45 participants at risk Participants received durvalumab 1500 mg via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by durvalumab monotherapy continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.	Placebo + SoC n=44 participants at risk Participants received matching placebo via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by matching placebo continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.
Infections and infestations Pneumonia	6.7% 3/45 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	2.3% 1/44 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Infections and infestations Respiratory tract infection	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/45 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	2.3% 1/44 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Injury, poisoning and procedural complications Subdural haematoma	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Cardiac disorders Cardiac arrest	0.00% 0/45 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	2.3% 1/44 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Investigations Blood creatinine increased	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Metabolism and nutrition disorders Decreased appetite	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Metabolism and nutrition disorders Hyponatraemia	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Nervous system disorders Cerebrovascular accident	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Nervous system disorders Loss of consciousness	0.00% 0/45 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	2.3% 1/44 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Nervous system disorders Parkinson's disease	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Blood and lymphatic system disorders Anaemia	4.4% 2/45 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Renal and urinary disorders Acute kidney injury	0.00% 0/45 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	4.5% 2/44 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Renal and urinary disorders Azotaemia	0.00% 0/45 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	2.3% 1/44 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Renal and urinary disorders Chronic kidney disease	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.00% 0/45 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	2.3% 1/44 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Endocrine disorders Hypopituitarism	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Vascular disorders Peripheral arterial occlusive disease	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Vascular disorders Peripheral artery occlusion	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Vascular disorders Peripheral ischaemia	0.00% 0/45 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	2.3% 1/44 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Blood and lymphatic system disorders Febrile neutropenia	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Gastrointestinal disorders Colitis	6.7% 3/45 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Gastrointestinal disorders Nausea	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Blood and lymphatic system disorders Neutropenia	0.00% 0/45 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	2.3% 1/44 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
General disorders General physical health deterioration	0.00% 0/45 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	2.3% 1/44 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Blood and lymphatic system disorders Pancytopenia	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Hepatobiliary disorders Drug-induced liver injury	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Blood and lymphatic system disorders Thrombocytopenia	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Infections and infestations COVID-19	0.00% 0/45 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	4.5% 2/44 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Infections and infestations Erysipelas	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Infections and infestations Influenza	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).

Other adverse events
Measure	Durvalumab + SoC n=45 participants at risk Participants received durvalumab 1500 mg via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by durvalumab monotherapy continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.	Placebo + SoC n=44 participants at risk Participants received matching placebo via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by matching placebo continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles. For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.
Gastrointestinal disorders Stomatitis	6.7% 3/45 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	6.8% 3/44 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Gastrointestinal disorders Vomiting	11.1% 5/45 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	6.8% 3/44 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
General disorders Asthenia	15.6% 7/45 • Number of events 10 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	9.1% 4/44 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Infections and infestations Nasopharyngitis	4.4% 2/45 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	6.8% 3/44 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Infections and infestations Urinary tract infection	6.7% 3/45 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	2.3% 1/44 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Investigations Neutrophil count decreased	17.8% 8/45 • Number of events 15 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	11.4% 5/44 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Investigations Platelet count decreased	6.7% 3/45 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	4.5% 2/44 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Investigations Weight decreased	4.4% 2/45 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	6.8% 3/44 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Investigations White blood cell count decreased	15.6% 7/45 • Number of events 10 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	4.5% 2/44 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Metabolism and nutrition disorders Decreased appetite	20.0% 9/45 • Number of events 14 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	15.9% 7/44 • Number of events 11 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Metabolism and nutrition disorders Hypomagnesaemia	6.7% 3/45 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	6.8% 3/44 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Musculoskeletal and connective tissue disorders Arthralgia	15.6% 7/45 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	18.2% 8/44 • Number of events 13 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Musculoskeletal and connective tissue disorders Back pain	11.1% 5/45 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	6.8% 3/44 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.7% 3/45 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	2.3% 1/44 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
General disorders Fatigue	33.3% 15/45 • Number of events 18 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	27.3% 12/44 • Number of events 13 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Musculoskeletal and connective tissue disorders Myalgia	8.9% 4/45 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	11.4% 5/44 • Number of events 12 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Musculoskeletal and connective tissue disorders Pain in extremity	4.4% 2/45 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	9.1% 4/44 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Nervous system disorders Anosmia	6.7% 3/45 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Nervous system disorders Dizziness	8.9% 4/45 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	4.5% 2/44 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Nervous system disorders Dysgeusia	8.9% 4/45 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	4.5% 2/44 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Nervous system disorders Headache	17.8% 8/45 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	9.1% 4/44 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Nervous system disorders Neuropathy peripheral	15.6% 7/45 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	11.4% 5/44 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Nervous system disorders Paraesthesia	6.7% 3/45 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	6.8% 3/44 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Nervous system disorders Peripheral sensory neuropathy	2.2% 1/45 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	13.6% 6/44 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Blood and lymphatic system disorders Anaemia	33.3% 15/45 • Number of events 21 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	27.3% 12/44 • Number of events 13 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Psychiatric disorders Insomnia	13.3% 6/45 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	9.1% 4/44 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Respiratory, thoracic and mediastinal disorders Cough	15.6% 7/45 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	11.4% 5/44 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.9% 4/45 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	9.1% 4/44 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Respiratory, thoracic and mediastinal disorders Hiccups	4.4% 2/45 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	9.1% 4/44 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Respiratory, thoracic and mediastinal disorders Productive cough	6.7% 3/45 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	6.8% 3/44 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Endocrine disorders Hyperthyroidism	13.3% 6/45 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Skin and subcutaneous tissue disorders Alopecia	28.9% 13/45 • Number of events 13 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	20.5% 9/44 • Number of events 10 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Skin and subcutaneous tissue disorders Dry skin	8.9% 4/45 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	6.8% 3/44 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Skin and subcutaneous tissue disorders Pruritus	13.3% 6/45 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	13.6% 6/44 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Skin and subcutaneous tissue disorders Rash	17.8% 8/45 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	11.4% 5/44 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Skin and subcutaneous tissue disorders Rash maculo-papular	6.7% 3/45 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	6.8% 3/44 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Endocrine disorders Hypothyroidism	13.3% 6/45 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	2.3% 1/44 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Vascular disorders Hypertension	6.7% 3/45 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	9.1% 4/44 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Eye disorders Lacrimation increased	6.7% 3/45 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	0.00% 0/44 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).
Gastrointestinal disorders Abdominal pain	11.1% 5/45 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).	4.5% 2/44 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from first dose of study treatment up to 90 days after the last dose of study treatment, 19.1 months. All-cause mortality was assessed from the start of randomization up to completion of study, 35 months. The safety analysis set consisted of all randomized participants who received at least 1 dose of study treatment (durvalumab/placebo and/or SoC chemotherapy).