Completed
PHASE1, PHASE2
INTERVENTIONAL
NCT02039674
A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of this study is to determine the safety, tolerability, and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy or immunotherapy in participants with unresectable or metastatic non-small cell lung cancer (NSCLC).
Interventions
Name:
Pembrolizumab
Type:
BIOLOGICAL
Description:
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Name:
Paclitaxel
Type:
DRUG
Description:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Name:
Carboplatin
Type:
DRUG
Description:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Name:
Bevacizumab
Type:
BIOLOGICAL
Description:
IV on Day 1 of each 3-week cycle
Name:
Pemetrexed
Type:
DRUG
Description:
IV on Day 1 of each 3-week cycle
Name:
Ipilimumab
Type:
BIOLOGICAL
Description:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Name:
Erlotinib
Type:
DRUG
Description:
Orally tablet once daily
Name:
Gefitinib
Type:
DRUG
Description:
Oral tablet once daily
Primary Outcomes
Measure:
Part 2 Cohorts G+ and G-: Objective Response Rate (ORR)
TimeFrame:
Up to approximately 2 years
Description:
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Measure:
Part 2 Cohorts D4 and H: Objective Response Rate (ORR)
TimeFrame:
Up to approximately 2 years
Description:
For participants who demonstrated a confirmed response (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. Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.
Measure:
All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
TimeFrame:
Cycle 1 (Up to 21 days)
Description:
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. A DLT was defined as any of the following events: Grade 4 non-hematologic toxicity (not laboratory); Grade 4 hematologic toxicity lasting ≥7 days; Grade 3 non-hematologic toxicity (not laboratory, specifically nausea, vomiting and diarrhea) lasting \>3 days despite optimal supportive care; Any Grade 3 or Grade 4 non-hematologic laboratory value requiring treatment or hospitalization, or persisting for \>1 week; Febrile neutropenia Grade 3 or Grade 4; Qualifying thrombocytopenia \<25,000/mm\^3; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Missing \>10% of erlotinib or gefitinib doses as a result of adverse events (AEs) during the DLT window of observation; or Grade 5 toxicity.
Trial Information
NCT ID
NCT02039674
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1, PHASE2
Sponsor
Merck Sharp & Dohme LLC
Last Updated
December 15, 2025