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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03976323.
This study has 2 phases: an Induction Phase of up to ~4 Cycles (up to ~12 weeks [cycle =3
weeks]) and a Maintenance Phase of up to ~31 cycles of pembrolizumab (cycle = 3 weeks]);
total pembrolizumab treatment duration will be up to ~35 cycles (up to ~2 years). In the
Induction Phase, participants receive pembrolizumab plus pemetrexed plus platinum
(carboplatin or cisplatin, at the investigator's discretion). 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 pemetrexed. In the Maintenance Phase, participants receive pembrolizumab
for up to 31 cycles (cycle = 3 weeks) plus maintenance olaparib OR maintenance pemetrexed
until progressive disease (PD), intolerable toxicities, or physician decision.
Qualified participants in each study arm of the maintenance phase (Pembrolizumab plus
Olaparib and Pembrolizumab plus Pemetrexed) who complete up to ~35 cycles of
pembrolizumab (up to ~2 years [cycle =3 weeks]) may be eligible to receive a second
course of pembrolizumab for up to ~17 cycles (up to ~1 additional year). Per protocol,
response or progression during the second pembrolizumab course will not be counted
towards patient reported outcomes (PROs) or efficacy outcome measures and adverse events
during the second pembrolizumab course will not be counted towards safety outcome
measures.
Lead OrganizationMerck Sharp and Dohme LLC