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)
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)
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:
As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.
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.
Inclusion Criteria:
Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
Have Stage IV squamous NSCLC.
Have measurable disease based on RECIST 1.1.
Have not received prior systemic treatment for their advanced/metastatic NSCLC.
Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention
Have a life expectancy of at least 3 months.
Has adequate organ function.
Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.
Exclusion Criteria:
Merrillville, Indiana 46410, United States
Mar del Plata, Buenos Aires B7600FZO, Argentina
Salvador - BA, Estado de Bahia 41253-190, Brazil
Porto Alegre, Rio Grande do Sul 90050-170, Brazil
ItajaÃ, Santa Catarina 88301-220, Brazil
Sao Jose Rio Preto, São Paulo 15090-000, Brazil
Rio de Janeiro, 20230-130, Brazil
Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54519, France
Koblenz, Rhineland-Palatinate 56068, Germany
Sakai, Osaka 591-8555, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Palmerston North, Manawatu-Wanganui 4414, New Zealand
Wellington, 6021, New Zealand
Krakow, Lesser Poland Voivodeship 31-202, Poland
Olsztyn, Lower Silesian Voivodeship 10-357, Poland
Zgorzelec, Lower Silesian Voivodeship 59-900, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Moscow, Moscow 115478, Russia
Moscow, Moscow 125284, Russia
Moscow, Moscow 125367, Russia
Nizhny Novgorod, Nizhny Novgorod Oblast 603081, Russia
Omsk, Omsk Oblast 644013, Russia
Saint Petersburg, Sankt-Peterburg 194291, Russia
Saint Petersburg, Sankt-Peterburg 197758, Russia
Saint Petersburg, Sankt-Peterburg 198255, Russia
Kazan', Tatarstan, Respublika 420029, Russia
Gyeonggi-do, Kyonggi-do 16247, South Korea
Songpa-gu, Seoul 05505, South Korea
Istanbul, 34093, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)
Samsun, 55270, Turkey (Türkiye)
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018, Ukraine
Kharkiv, Kharkiv Oblast 61024, Ukraine
Kropyvnytskyi, Kirovohrad Oblast 25006, Ukraine
Westcliff-on-Sea, Essex SS0 0RY, United Kingdom
London, London, City of EC1M 6BQ, United Kingdom
Newcastle upon Tyne, Newcastle Upon Tyne NE7 7DN, United Kingdom