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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)

NCT02039674 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2022-11-08

Study results available
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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).

Conditions

  • Non-small Cell Lung Carcinoma

Interventions

BIOLOGICAL

Pembrolizumab

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

DRUG

Paclitaxel

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

DRUG

Carboplatin

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

BIOLOGICAL

Bevacizumab

IV on Day 1 of each 3-week cycle

DRUG

Pemetrexed

IV on Day 1 of each 3-week cycle

BIOLOGICAL

Ipilimumab

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

DRUG

Erlotinib

Orally tablet once daily

DRUG

Gefitinib

Oral tablet once daily

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-21
Primary Completion
2016-11-07
Completion
2021-10-18

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02039674 on ClinicalTrials.gov