CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,003 enrolled
Drug / intervention
Pembrolizumab +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03976323
NCT03976323Phase 3Completed

A Phase 3 Study of Pembrolizumab in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants With Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC)

Merck Sharp & Dohme LLC·interventional·Posted Jun 6, 2019·Updated Feb 25, 2026

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab, Pemetrexed, and 3 other interventions for Carcinoma, Nonsquamous Non-small-cell Lung. Completed, enrolled 1,003 participants across 178 sites in 20 countries.

Detailed Summary

The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, versus (vs) pembrolizumab plus maintenance pemetrexed for the treatment of non-squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Austria, Brazil, Canada, Colombia, France, Germany, Japan, New Zealand, Poland, Romania, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 6, 2019
Enrollment StartJun 28, 2019
Primary CompletionFeb 7, 2024
Study CompletionJan 29, 2026
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 7.1 years ago

Interventions

Pembrolizumabbiological

IV infusion

Pemetrexeddrug

IV infusion

Carboplatindrug

IV infusion

Cisplatindrug

IV infusion

Olaparibdrug

Oral Tablet