At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab, Carboplatin, and 4 other interventions for Carcinoma, Squamous Cell, Non-small-cell Lung. Completed, enrolled 851 participants across 178 sites in 20 countries.
Detailed Summary
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS). As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.
Study Details
Timeline
Interventions
IV infusion
IV infusion
IV infusion
IV infusion
Tablets
Placebo to olaparib, tablets