Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus... | NCT04956692

NCT04956692

ID	Type	Description
MK-3475-A86	Other Identifier	MSD
jRCT2021210032	Registry Identifier	jRCT (Japan Registry of Clinical Trials)
2023-508308-40	Registry Identifier	EU CT
U1111-1298-0215	Other Identifier	UTN
2020-002729-27	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy	Experimental	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.	Biological: Pembrolizumab SC Drug: Paclitaxel Drug: Nab-Paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed
Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy	Active Comparator	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.	Biological: Pembrolizumab IV Drug: Paclitaxel Drug: Nab-Paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab SC	Biological	SC injection	Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cycle 1 Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab	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.	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.
Cycle 6 Model-Based Minimal Concentration (Ctrough) of Pembrolizumab	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.	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.

Secondary Outcomes

Measure	Description	Time Frame
Objective Response (OR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has pathologically (histologically or cytologically) confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC)
Has Stage IV (T any, N any, M1a, M1b, or M1c - American Joint Committee on Cancer 8th Edition) squamous or nonsquamous NSCLC
Has confirmation that epidermal growth factor receptor (EGFR), Anaplastic lymphoma kinase (ALK), or ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS1)-directed therapy is not indicated in nonsquamous NSCLC as well as mixed nonsquamous/squamous NSCLC. Participants with purely squamous NSCLC do not require testing
Has not received prior systemic treatment for their metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease
Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 or 1
Male participants are eligible to participate if they agree to use contraception as per protocol unless confirmed to be azoospermic
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees of using a contraceptive method per protocol
Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
Submit an archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated for PD-L1 status determination prior to randomization
Has adequate organ function

Exclusion Criteria:

Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known central nervous system (ie, brain and/or spinal cord) metastases and/or carcinomatous meningitis. Participants with treated brain metastases may participate only if they satisfy all of the following: a) Have no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging performed at least 4 weeks after pretreatment brain imaging, and b) Are neurologically stable without the need for steroids for at least 14 days before first dose of trial treatment as per local site assessment
Has severe hypersensitivity to study intervention and/or any of its excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection and/or Hepatitis B infection or known active Hepatitis C infection
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Has symptomatic ascites or pleural effusion. A participant who is clinically stable after treatment for these conditions is eligible
Before the first dose of study intervention: a) Has received prior systemic cytotoxic chemotherapy for metastatic NSCLC b) Has received antineoplastic biological therapy for metastatic NSCLC c) Has had major surgery (<3 weeks prior to first dose) d) Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention
Is expected to require any other form of antineoplastic therapy while on study
For participants with nonsquamous histology: Is unable to interrupt aspirin or other Non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period
For participants with nonsquamous histology: Is unable or unwilling to take folic acid or vitamin B12 supplementation
Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
Has had an allogenic tissue/solid organ transplant

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
St. Bernards Medical Center ( Site 0103)		Jonesboro	Arkansas	72401	United States
St Joseph Heritage Healthcare-Oncology ( Site 0102)

Label	URL
Merck Clinical Trials Information	View source
Plain Language Summary	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 12, 2023

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Cycle 1 Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab

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.

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.

Posted

Geometric Mean

95% Confidence Interval

hr*µg/mL

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.

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000355 OG001170

Title

Denominators

Categories

Title	Measurements
	OG000471.33(452.22 to 491.26) OG001454.96(438.54 to 471.99)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 1 sided	Welch's unequal variances t-test. The null hypothesis was that GMR≤0.8.	<0.0001	The one-sided p-value non-inferiority boundary is 0.02	Geometric Mean Ratio (GMR)	1.04			2-Sided	96	0.98	1.10			Numerator Arm A/Denominator Arm B		Non-Inferiority	The non-inferiority margin with respect to the geometric means ratio (GMR) was 0.8

Primary

Cycle 6 Model-Based Minimal Concentration (Ctrough) of Pembrolizumab

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.

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.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

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.

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Objective Response (OR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

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.

Not Posted

Oct 2027

Up to approximately 5 years

Participants

Secondary

Cycle 1 Observed Ctrough of Pembrolizumab

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.

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

Posted

Geometric Mean

95% Confidence Interval

µg/mL

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Cycle 1 Maximum Concentration (Cmax) of Pembrolizumab

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.

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

Posted

Geometric Mean

95% Confidence Interval

µg/mL

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.

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Cycle 6 AUC 0-3wks of Pembrolizumab

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.

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.

Posted

Geometric Mean

95% Confidence Interval

hr*µg/mL

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.

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Cycle 6 Cmax of Pembrolizumab

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.

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

Posted

Geometric Mean

95% Confidence Interval

µg/mL

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.

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Cycle 6 Observed Ctrough of Pembrolizumab

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.

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

Posted

Geometric Mean

95% Confidence Interval

µg/mL

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants Who Experienced an Adverse Event (AE)

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.

Not Posted

Oct 2027

Up to approximately 28 months

Participants

Secondary

Number of Participants Who Discontinued Study Treatment Due to an AE

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.

Not Posted

Oct 2027

Up to approximately 25 months

Participants

Secondary

Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR

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.

Not Posted

Oct 2027

Up to approximately 5 years

Participants

Secondary

Overall Survival (OS)

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

Not Posted

Oct 2027

Up to approximately 5 years

Participants

Secondary

Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

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.

Not Posted

Oct 2027

Up to approximately 5 years

Participants

Secondary

Anti-Drug Antibodies (ADAs) Incidence After Administration of Pembrolizumab

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

Not Posted

Oct 2027

Up to approximately 26 months

Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	118	358	132	356	331	356
EG001	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.	48	173	62	172	160	172

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00019 events18 affected356 at risk EG0012 events2 affected172 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0009 events9 affected356 at risk EG0015 events5 affected172 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0008 events7 affected356 at risk EG0013 events3 affected172 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected356 at risk EG0014 events3 affected172 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Cardiac arrest	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0012 events2 affected172 at risk
Pericardial effusion	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected356 at risk EG0010 events0 affected172 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Supraventricular tachyarrhythmia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Aplasia	Congenital, familial and genetic disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0011 events1 affected172 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Macular hole	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Colitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected356 at risk EG0011 events1 affected172 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0011 events1 affected172 at risk
Ileus	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Oesophageal fistula	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected356 at risk EG0013 events3 affected172 at risk
Death	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected356 at risk EG0010 events0 affected172 at risk
Face oedema	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0013 events3 affected172 at risk
Generalised oedema	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Hypothermia	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Injection site exfoliation	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Non-cardiac chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0012 events2 affected172 at risk
Pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Peripheral swelling	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Sudden death	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0012 events1 affected172 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Appendicitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Bronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected356 at risk EG0013 events3 affected172 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected356 at risk EG0011 events1 affected172 at risk
Cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0011 events1 affected172 at risk
Diverticulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Haemophilus infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Herpes zoster	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0012 events2 affected172 at risk
Infected fistula	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Laryngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Pleural infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00011 events11 affected356 at risk EG00111 events10 affected172 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0011 events1 affected172 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Pyopneumothorax	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected356 at risk EG0011 events1 affected172 at risk
Septic shock	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Staphylococcal infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Systemic infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0012 events2 affected172 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Blood bilirubin increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Blood creatinine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
C-reactive protein increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
White blood cell count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0011 events1 affected172 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0011 events1 affected172 at risk
Connective tissue inflammation	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Soft tissue haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Seizure	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Confusional state	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0012 events1 affected172 at risk
Delusional disorder, unspecified type	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Immune-mediated nephritis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Renal impairment	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0010 events0 affected172 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected356 at risk EG0016 events4 affected172 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0013 events2 affected172 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0011 events1 affected172 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected356 at risk EG0016 events6 affected172 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0011 events1 affected172 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected356 at risk EG0011 events1 affected172 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected356 at risk EG0011 events1 affected172 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0013 events3 affected172 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Arterial thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Embolism	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0011 events1 affected172 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected356 at risk EG0011 events1 affected172 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected356 at risk EG0010 events0 affected172 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG000237 events188 affected356 at risk EG001118 events100 affected172 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG000218 events116 affected356 at risk EG001107 events52 affected172 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG000137 events83 affected356 at risk EG00162 events40 affected172 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG00026 events24 affected356 at risk EG0018 events7 affected172 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG00027 events25 affected356 at risk EG0018 events8 affected172 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00070 events57 affected356 at risk EG00133 events27 affected172 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00077 events59 affected356 at risk EG00128 events23 affected172 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000141 events98 affected356 at risk EG00164 events48 affected172 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00024 events22 affected356 at risk EG0015 events5 affected172 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00039 events32 affected356 at risk EG00117 events12 affected172 at risk
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG00056 events46 affected356 at risk EG00138 events31 affected172 at risk
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG00046 events41 affected356 at risk EG00115 events14 affected172 at risk
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG00025 events24 affected356 at risk EG00113 events13 affected172 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG00027 events24 affected356 at risk EG0018 events8 affected172 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00024 events24 affected356 at risk EG00111 events11 affected172 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00060 events46 affected356 at risk EG00137 events26 affected172 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00063 events46 affected356 at risk EG00140 events29 affected172 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00026 events18 affected356 at risk EG00114 events12 affected172 at risk
Blood creatinine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00044 events34 affected356 at risk EG00127 events18 affected172 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00022 events22 affected356 at risk EG00111 events10 affected172 at risk
Lymphocyte count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00026 events19 affected356 at risk EG00115 events10 affected172 at risk
White blood cell count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00081 events50 affected356 at risk EG00141 events26 affected172 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00074 events60 affected356 at risk EG00127 events25 affected172 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00036 events24 affected356 at risk EG00112 events10 affected172 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00020 events19 affected356 at risk EG00113 events12 affected172 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00019 events17 affected356 at risk EG0019 events9 affected172 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00026 events18 affected356 at risk EG0018 events6 affected172 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00016 events15 affected356 at risk EG00114 events12 affected172 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00037 events31 affected356 at risk EG00119 events11 affected172 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00018 events17 affected356 at risk EG00117 events15 affected172 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00020 events20 affected356 at risk EG00115 events13 affected172 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00021 events19 affected356 at risk EG0018 events8 affected172 at risk
Insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG00023 events22 affected356 at risk EG0019 events8 affected172 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00021 events19 affected356 at risk EG00113 events8 affected172 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00022 events20 affected356 at risk EG00113 events12 affected172 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00021 events20 affected356 at risk EG0014 events4 affected172 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00047 events47 affected356 at risk EG00123 events23 affected172 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00027 events24 affected356 at risk EG0019 events9 affected172 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00028 events25 affected356 at risk EG00119 events15 affected172 at risk

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
C565324	Parkinson Disease 4, Autosomal Dominant Lewy Body

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
C582435	pembrolizumab
D017239	Paclitaxel
D013660	Taxes
C520255	130-nm albumin-bound paclitaxel
D000068196	Albumin-Bound Paclitaxel
D016190	Carboplatin
D002945	Cisplatin
D000068437	Pemetrexed

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D004467	Economics
D004472	Health Care Economics and Organizations
D000418	Albumins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D056831	Coordination Complexes
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000600	Amino Acids, Dicarboxylic