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Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024)

NCT02142738 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2022-06-13

Study results available
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Summary

This is a study to assess the efficacy and safety of pembrolizumab (MK-3475/SCH 900475) compared to standard of care (SOC) platinum-based chemotherapies in the treatment of participants with previously untreated stage IV, programmed cell death ligand 1 (PD-L1) strong expressing Non-Small Cell Lung Cancer (NSCLC). The primary hypothesis of this study is that participants with PD-L1 strong NSCLC will have a longer Progression Free Survival (PFS), as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) when treated with pembrolizumab than when treated with SOC platinum-based chemotherapies.

With Amendment 09 (20 December 2017), once participants have achieved the study objective or the study has ended, participants will be discontinued from this study and enrolled in an extension study to continue protocol-defined assessments and treatment.

Conditions

  • Non-Small Cell Lung Carcinoma

Interventions

DRUG

Pembrolizumab

Pembrolizumab IV solution

DRUG

Paclitaxel

Paclitaxel IV solution

DRUG

Carboplatin

Carboplatin IV solution

DRUG

Pemetrexed

Pemetrexed Lyophilized Powder for Infusion

DRUG

Cisplatin

Cisplatin IV solution

DRUG

Gemcitabine

Gemcitabine Lyophilized Powder for Infusion

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
2014-08-25
Primary Completion
2016-05-09
Completion
2021-05-27
FDA Drug
Yes

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Drugs
Companies

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 NCT02142738 on ClinicalTrials.gov