Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86) (NCT NCT04956692)

Last Updated: 2024-12-03

Results Overview

Cycle 1 AUC0-3wks is defined as the area under the concentration-time curve for pembrolizumab in plasma over a 3-week dosing interval in Cycle 1. Each cycle is 21 days.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

531 participants

Primary outcome timeframe

Cycle 1: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 2: predose day 1. Each cycle is 21 days.

Results posted on

2024-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.	Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.
Overall Study STARTED	358	173
Overall Study Treated	356	172
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	358	173

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.	Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.
Overall Study Death	115	47
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Parent/Guardian	2	0
Overall Study Withdrawal by Subject	5	2
Overall Study Ongoing in Study	236	123

Baseline Characteristics

Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy n=358 Participants Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.	Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy n=173 Participants Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.	Total n=531 Participants Total of all reporting groups
Age, Continuous	64.1 Years STANDARD_DEVIATION 8.6 • n=5 Participants	65.6 Years STANDARD_DEVIATION 9.2 • n=7 Participants	64.6 Years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	47 Participants n=7 Participants	148 Participants n=5 Participants
Sex: Female, Male Male	257 Participants n=5 Participants	126 Participants n=7 Participants	383 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	50 Participants n=5 Participants	27 Participants n=7 Participants	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	307 Participants n=5 Participants	146 Participants n=7 Participants	453 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Asian	72 Participants n=5 Participants	32 Participants n=7 Participants	104 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	232 Participants n=5 Participants	113 Participants n=7 Participants	345 Participants n=5 Participants
Race (NIH/OMB) More than one race	24 Participants n=5 Participants	14 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Cycle 1: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 2: predose day 1. Each cycle is 21 days.

Population: The analysis population includes all randomized participants with at least 1 postdose sample in cycle 1, and for whom a model-based assessment could be done.

Cycle 1 AUC0-3wks is defined as the area under the concentration-time curve for pembrolizumab in plasma over a 3-week dosing interval in Cycle 1. Each cycle is 21 days.

Outcome measures

Outcome measures
Measure	Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy n=355 Participants Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.	Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy n=170 Participants Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.
Cycle 1 Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab	471.33 hr*µg/mL Interval 452.22 to 491.26	454.96 hr*µg/mL Interval 438.54 to 471.99

PRIMARY outcome

Timeframe: Cycle 6: predose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.

Population: The analysis population includes all randomized participants with at least 1 postdose sample in cycle 1, and for whom a model-based assessment could be done.

Cycle 6 model-based Ctrough is defined as the lowest concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 6, as predicted by the pharmacokinetic (PK) model based on historical intravenous pembrolizumab PK data. Each cycle is 21 days.

Outcome measures

Outcome measures
Measure	Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy n=240 Participants Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.	Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy n=93 Participants Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.
Cycle 6 Model-Based Minimal Concentration (Ctrough) of Pembrolizumab	55.93 µg/mL Interval 53.05 to 58.96	30.25 µg/mL Interval 27.93 to 32.77

SECONDARY outcome

Timeframe: Up to approximately 5 years

The OR rate is defined as the percentage of participants who achieve a confirmed complete response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose Cycle 2 day 1. Each cycle is 21 days.

Population: The analysis population includes all randomized participants with at least 1 postdose sample in cycle 1.

Cycle 1 observed Ctrough is defined as the lowest observed concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 1. Each cycle is 21 days.

Outcome measures

Outcome measures
Measure	Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy n=263 Participants Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.	Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy n=134 Participants Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.
Cycle 1 Observed Ctrough of Pembrolizumab	18.36 µg/mL Interval 17.19 to 19.61	11.16 µg/mL Interval 10.49 to 11.88

SECONDARY outcome

Timeframe: Cycle 1: predose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 2: predose day 1. Each cycle is 21 days.

Population: The analysis population includes all randomized participants with at least 1 postdose sample in cycle 1.

Cycle 1 Cmax is defined as the observed peak concentration of pembrolizumab in plasma over the dosing interval in Cycle 1. Each cycle is 21 days.

Outcome measures

Outcome measures
Measure	Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy n=355 Participants Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.	Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy n=170 Participants Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.
Cycle 1 Maximum Concentration (Cmax) of Pembrolizumab	25.2 µg/mL Interval 23.8 to 26.6	58.3 µg/mL Interval 55.7 to 61.0

SECONDARY outcome

Timeframe: Cycle 6: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.

Population: The analysis population includes all randomized participants with at least 1 postdose sample in cycle 6, and for whom a model-based assessment could be done.

Cycle 6 AUC0-3wks is defined as the area under the concentration-time curve for pembrolizumab in plasma over a 3-week dosing interval in Cycle 6. Each cycle is 21 days.

Outcome measures

Outcome measures
Measure	Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy n=240 Participants Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.	Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy n=93 Participants Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.
Cycle 6 AUC 0-3wks of Pembrolizumab	1403.8 hr*µg/mL Interval 1342.0 to 1468.5	952.9 hr*µg/mL Interval 896.4 to 1013.0

SECONDARY outcome

Timeframe: Cycle 6: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.

Population: The analysis population includes all randomized participants with at least 1 postdose sample in cycle 6.

Cmax in Cycle 6 is defined as the observed peak concentration of pembrolizumab in plasma over the dosing interval in Cycle 6. Each cycle is 21 days.

Outcome measures

Outcome measures
Measure	Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy n=240 Participants Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.	Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy n=93 Participants Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.
Cycle 6 Cmax of Pembrolizumab	65.6 µg/mL Interval 62.2 to 69.0	85.6 µg/mL Interval 80.1 to 91.4

SECONDARY outcome

Timeframe: Predose Cycle 7 day 1. Each cycle is 21 days.

Population: The analysis population includes all randomized participants with at least 1 postdose sample in cycle 6.

Cycle 6 observed Ctrough is defined as the lowest observed concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 6. Each cycle is 21 days.

Outcome measures

Outcome measures
Measure	Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy n=61 Participants Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.	Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy n=23 Participants Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.
Cycle 6 Observed Ctrough of Pembrolizumab	57.17 µg/mL Interval 52.23 to 62.58	33.19 µg/mL Interval 29.53 to 37.3

SECONDARY outcome

Timeframe: Up to approximately 28 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 25 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants who discontinue study treatment due to an AE will be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 5 years

PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 5 years

OS is defined as the time from randomization to death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 5 years

For participants who show confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 26 months

ADA incidence will be assessed by analyzing the development of ADAs following administration of pembrolizumab SC and pembrolizumab IV.

Outcome measures

Outcome data not reported

Adverse Events

Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy

Serious events: 132 serious events

Other events: 331 other events

Deaths: 118 deaths

Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy

Serious events: 62 serious events

Other events: 160 other events

Deaths: 48 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER

Measure	Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy n=356 participants at risk Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.	Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy n=172 participants at risk Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.
Blood and lymphatic system disorders Anaemia	52.8% 188/356 • Number of events 237 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	58.1% 100/172 • Number of events 118 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	32.6% 116/356 • Number of events 218 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	30.2% 52/172 • Number of events 107 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	23.3% 83/356 • Number of events 137 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	23.3% 40/172 • Number of events 62 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Endocrine disorders Hyperthyroidism	6.7% 24/356 • Number of events 26 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	4.1% 7/172 • Number of events 8 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Endocrine disorders Hypothyroidism	7.0% 25/356 • Number of events 27 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	4.7% 8/172 • Number of events 8 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Gastrointestinal disorders Constipation	16.0% 57/356 • Number of events 70 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	15.7% 27/172 • Number of events 33 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Gastrointestinal disorders Diarrhoea	16.6% 59/356 • Number of events 77 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	13.4% 23/172 • Number of events 28 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Gastrointestinal disorders Nausea	27.5% 98/356 • Number of events 141 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	27.9% 48/172 • Number of events 64 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Gastrointestinal disorders Stomatitis	6.2% 22/356 • Number of events 24 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	2.9% 5/172 • Number of events 5 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Gastrointestinal disorders Vomiting	9.0% 32/356 • Number of events 39 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	7.0% 12/172 • Number of events 17 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
General disorders Asthenia	12.9% 46/356 • Number of events 56 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	18.0% 31/172 • Number of events 38 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
General disorders Fatigue	11.5% 41/356 • Number of events 46 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	8.1% 14/172 • Number of events 15 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
General disorders Oedema peripheral	6.7% 24/356 • Number of events 25 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	7.6% 13/172 • Number of events 13 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
General disorders Pyrexia	6.7% 24/356 • Number of events 27 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	4.7% 8/172 • Number of events 8 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Infections and infestations COVID-19	6.7% 24/356 • Number of events 24 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	6.4% 11/172 • Number of events 11 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Investigations Alanine aminotransferase increased	12.9% 46/356 • Number of events 60 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	15.1% 26/172 • Number of events 37 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Investigations Aspartate aminotransferase increased	12.9% 46/356 • Number of events 63 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	16.9% 29/172 • Number of events 40 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Investigations Blood alkaline phosphatase increased	5.1% 18/356 • Number of events 26 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	7.0% 12/172 • Number of events 14 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Investigations Blood creatinine increased	9.6% 34/356 • Number of events 44 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	10.5% 18/172 • Number of events 27 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Investigations Blood lactate dehydrogenase increased	6.2% 22/356 • Number of events 22 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	5.8% 10/172 • Number of events 11 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Investigations Lymphocyte count decreased	5.3% 19/356 • Number of events 26 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	5.8% 10/172 • Number of events 15 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Investigations White blood cell count decreased	14.0% 50/356 • Number of events 81 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	15.1% 26/172 • Number of events 41 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	16.9% 60/356 • Number of events 74 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	14.5% 25/172 • Number of events 27 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	6.7% 24/356 • Number of events 36 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	5.8% 10/172 • Number of events 12 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	5.3% 19/356 • Number of events 20 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	7.0% 12/172 • Number of events 13 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	4.8% 17/356 • Number of events 19 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	5.2% 9/172 • Number of events 9 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	5.1% 18/356 • Number of events 26 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	3.5% 6/172 • Number of events 8 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	4.2% 15/356 • Number of events 16 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	7.0% 12/172 • Number of events 14 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	8.7% 31/356 • Number of events 37 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	6.4% 11/172 • Number of events 19 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Nervous system disorders Dizziness	4.8% 17/356 • Number of events 18 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	8.7% 15/172 • Number of events 17 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Nervous system disorders Headache	5.6% 20/356 • Number of events 20 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	7.6% 13/172 • Number of events 15 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Nervous system disorders Neuropathy peripheral	5.3% 19/356 • Number of events 21 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	4.7% 8/172 • Number of events 8 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Psychiatric disorders Insomnia	6.2% 22/356 • Number of events 23 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	4.7% 8/172 • Number of events 9 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 19/356 • Number of events 21 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	4.7% 8/172 • Number of events 13 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.6% 20/356 • Number of events 22 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	7.0% 12/172 • Number of events 13 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Hiccups	5.6% 20/356 • Number of events 21 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	2.3% 4/172 • Number of events 4 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	13.2% 47/356 • Number of events 47 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	13.4% 23/172 • Number of events 23 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	6.7% 24/356 • Number of events 27 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	5.2% 9/172 • Number of events 9 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	7.0% 25/356 • Number of events 28 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.	8.7% 15/172 • Number of events 19 • Up to approximately 19 months All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.