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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03976362.
This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31
cycles of pembrolizumab). In the Induction Phase, participants receive pembrolizumab plus
carboplatin plus a taxane (paclitaxel or nab-paclitaxel). In the Maintenance Phase,
participants with a partial or complete disease response or with stable disease after
completing four cycles of induction therapy and who meet eligibility criteria will be
randomly assigned to receive pembrolizumab plus maintenance olaparib OR pembrolizumab
plus maintenance olaparib placebo. In the Maintenance Phase, participants randomly
assigned to receive pembrolizumab for up to 31 cycles plus maintenance olaparib OR
maintenance olaparib placebo until centrally verified progressive disease (PD),
intolerable toxicities, or physician decision.
As of Amendment 07, participants actively taking placebo will discontinue taking the
placebo intervention and continue in the study.
Lead OrganizationMerck Sharp and Dohme LLC