A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)

February 12, 2026 updated by: Merck Sharp & Dohme LLC

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:

  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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

851

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires ( Site 0511)
      • Córdoba, Argentina, X5004FHP
        • Clínica Universitaria Reina Fabiola ( Site 0505)
      • Santa Fe, Argentina, S3000AOL
        • Sanatorio Privado San Geronimo S.R.L ( Site 0510)
    • Buenos Aires
      • Bahía Blanca, Buenos Aires, Argentina, B8001HXM
        • Hospital Italiano Regional del Sur ( Site 0509)
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516)
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires ( Site 0500)
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, X5800AEV
        • Instituto Medico Rio Cuarto ( Site 0501)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000KZE
        • Centro Oncológico de Rosario ( Site 0507)
      • Rosario, Santa Fe Province, Argentina, S2000DSV
        • Sanatorio Parque ( Site 0515)
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IAK
        • Centro Medico San Roque ( Site 0506)
  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital ( Site 1201)
      • Wollongong, New South Wales, Australia, 2500
        • Southern Medical Day Care Centre ( Site 1200)
    • Queensland
      • Townsville, Queensland, Australia, 4814
        • Townsville General Hospital ( Site 1202)
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Cancer Centre ( Site 1205)
  • Austria
      • Vienna, Austria, 1210
        • Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Innsbruck LKH ( Site 1302)
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)
      • Wels, Upper Austria, Austria, 4600
        • Klinikum Wels-Grieskirchen ( Site 1304)
    • Vienna
      • Vienna, Vienna, Austria, 1145
        • Social Medical Center - Otto Wagner Hospital ( Site 1301)
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0253)
      • São Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0250)
      • São Paulo, Brazil, 01321-001
        • Hospital Paulistano - Amil Clinical Research ( Site 0263)
      • São Paulo, Brazil, 01321-001
        • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0260)
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-230
        • Instituto do Cancer do Ceara ( Site 0251)
    • Estado de Bahia
      • Salvador - BA, Estado de Bahia, Brazil, 41253-190
        • Hospital Sao Rafael ( Site 0258)
    • Pará
      • Belém, Pará, Brazil, 66053-000
        • Oncologica do Brasil ( Site 0256)
    • Rio Grande do Sul
      • Bento Gonçalves, Rio Grande do Sul, Brazil, 95700-000
        • Hospital Tacchini ( Site 0265)
      • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
        • Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0255)
    • Santa Catarina
      • Itajaí, Santa Catarina, Brazil, 88301-220
        • Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0252)
    • São Paulo
      • Sao Jose Rio Preto, São Paulo, Brazil, 15090-000
        • Hospital de Base de Sao Jose de Rio Preto ( Site 0254)
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Health Authority ( Site 0103)
    • Ontario
      • Hamilton, Ontario, Canada, L8V5C2
        • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0107)
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre ( Site 0102)
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Stronach Regional Cancer Centre ( Site 0100)
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • CISSS de la Monteregie-Centre ( Site 0101)
      • Laval, Quebec, Canada, H7M 3L9
        • Hopital Cite de la Sante de Laval ( Site 0105)
      • Montreal, Quebec, Canada, H3T 1M5
        • CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • CIUSSS de la Mauricie et du Centre du Quebec ( Site 0106)
  • France
    • Aisne
      • Chauny, Aisne, France, 02300
        • Centre Hospitalier De Chauny ( Site 1411)
    • Calvados
      • Caen, Calvados, France, 14033
        • CHU Caen ( Site 1406)
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49100
        • CHU Angers ( Site 1405)
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54519
        • Institut De Cancerologie De Lorraine ( Site 1409)
    • Moselle
      • Vantoux, Moselle, France, 57070
        • Hopital Robert Schuman ( Site 1402)
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, France, 63011
        • Centre Jean Perrin ( Site 1407)
    • Pyrenees-Atlantiques
      • Pau, Pyrenees-Atlantiques, France, 64000
        • Centre Hospitalier de Pau ( Site 1412)
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76000
        • CHU de Rouen ( Site 1403)
    • Val-de-Marne
      • Saint-Mandé, Val-de-Marne, France, 94163
        • Hopital d'Instruction des Armees Begin ( Site 1413)
  • Germany
      • Hamburg, Germany, 22087
        • Katholisches Marienkrankenhaus gGmbH ( Site 1572)
    • Bavaria
      • Aschaffenburg, Bavaria, Germany, 63739
        • Studienzentrum Aschaffenburg ( Site 1575)
      • Munich, Bavaria, Germany, 80336
        • Klinikum der LMU ( Site 1550)
      • Munich, Bavaria, Germany, 81925
        • Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1573)
      • Regensburg, Bavaria, Germany, 93042
        • Universitaetsklinikum Regensburg ( Site 1562)
      • Würzburg, Bavaria, Germany, 97074
        • Klinikum Wuerzburg Mitte gGmbH ( Site 1559)
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Universitaetsklinikum Frankfurt ( Site 1563)
      • Immenhausen, Hesse, Germany, 34376
        • Pneumologische Lehrklinik Universitaet Goettingen ( Site 1551)
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • Universitaetsmedizin Goettingen ( Site 1557)
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53105
        • Universitaetsklinikum Bonn ( Site 1574)
      • Essen, North Rhine-Westphalia, Germany, 45136
        • Kliniken Essen Mitte ( Site 1567)
    • Rhineland-Palatinate
      • Koblenz, Rhineland-Palatinate, Germany, 56068
        • InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1564)
    • Thuringia
      • Erfurt, Thuringia, Germany, 99089
        • Helios Klinikum Erfurt GmbH ( Site 1552)
  • Japan
      • Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center ( Site 0805)
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital ( Site 0808)
      • Okayama, Japan, 700-8558
        • Okayama University Hospital ( Site 0810)
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute ( Site 0809)
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR ( Site 0800)
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center ( Site 0806)
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Aichi Cancer Center Hospital ( Site 0803)
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East ( Site 0801)
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Kurume University Hospital ( Site 0814)
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital ( Site 0811)
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center ( Site 0807)
    • Miyagi
      • Sendai, Miyagi, Japan, 980-0873
        • Sendai Kousei Hospital ( Site 0812)
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital ( Site 0804)
      • Sakai, Osaka, Japan, 591-8555
        • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)
  • Mexico
      • Veracruz, Mexico, 91900
        • FAICIC Clinical Research ( Site 0303)
    • Baja California Sur
      • La Paz, Baja California Sur, Mexico, 23040
        • Investigacion Onco Farmaceutica S de RL de CV ( Site 0300)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0334)
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06700
        • Arke Estudios Clinicos ( Site 0333)
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64060
        • Axis Heilsa S. de R.L. de C.V. ( Site 0301)
    • Veracruz
      • Orizaba, Veracruz, Mexico, 94300
        • CLIMERS Clinical Medical Research ( Site 0306)
  • New Zealand
      • Wellington, New Zealand, 6021
        • Capital & Coast District Health Board - Wellington Hospital ( Site 1101)
    • Manawatu-Wanganui
      • Palmerston North, Manawatu-Wanganui, New Zealand, 4414
        • MidCentral DHB Palmerston North Hospital ( Site 1102)
  • Poland
    • Greater Poland Voivodeship
      • Konin, Greater Poland Voivodeship, Poland, 62-500
        • Przychodnia Lekarska Komed ( Site 2416)
      • Poznan, Greater Poland Voivodeship, Poland, 60-693
        • MED-POLONIA Sp. z o.o. ( Site 2419)
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-202
        • Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)
    • Lower Silesian Voivodeship
      • Olsztyn, Lower Silesian Voivodeship, Poland, 10-357
        • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)
      • Zgorzelec, Lower Silesian Voivodeship, Poland, 59-900
        • Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
    • Silesian Voivodeship
      • Racibórz, Silesian Voivodeship, Poland, 47-400
        • Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)
  • Romania
      • Bucharest, Romania, 022548
        • S.C.Focus Lab Plus S.R.L ( Site 2502)
      • Constanța, Romania, 900591
        • Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei ( Site 2501)
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 407280
        • S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)
      • Cluj-Napoca, Cluj, Romania, 400015
        • Cardiomed SRL Cluj-Napoca ( Site 2504)
    • Dolj
      • Craiova, Dolj, Romania, 200347
        • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)
    • Timiș County
      • Timișoara, Timiș County, Romania, 300239
        • Policlinica Oncomed SRL ( Site 2505)
  • Russia
    • Moscow
      • Moscow, Moscow, Russia, 115478
        • Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)
      • Moscow, Moscow, Russia, 119991
        • First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)
      • Moscow, Moscow, Russia, 125284
        • Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)
      • Moscow, Moscow, Russia, 125367
        • FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)
    • Moscow Oblast
      • Balashikha, Moscow Oblast, Russia, 143900
        • Moscow Regional Oncological Dispensary ( Site 2028)
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603081
        • Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)
    • Omsk Oblast
      • Omsk, Omsk Oblast, Russia, 644013
        • Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site
    • Samara Oblast
      • Samara, Samara Oblast, Russia, 443031
        • SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 194291
        • SBHI Leningrad Regional Clinical Hospital ( Site 2002)
      • Saint Petersburg, Sankt-Peterburg, Russia, 195271
        • SPb Central Clinical Railway Hospital ( Site 2003)
      • Saint Petersburg, Sankt-Peterburg, Russia, 197758
        • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)
      • Saint Petersburg, Sankt-Peterburg, Russia, 198255
        • SPb SBHI City Clinical Oncological Dispensary ( Site 2001)
    • Tatarstan, Respublika
      • Kazan', Tatarstan, Respublika, Russia, 420029
        • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021)
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital ( Site 1000)
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital ( Site 1008)
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System ( Site 1001)
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, South Korea, 10408
        • National Cancer Center ( Site 1006)
      • Gyeonggi-do, Kyonggi-do, South Korea, 16247
        • The Catholic University of Korea St. Vincent s Hospital ( Site 1003)
      • Suwon, Kyonggi-do, South Korea, 16499
        • Ajou University Hospital ( Site 1004)
    • Kyongsangnam-do
      • Jinju, Kyongsangnam-do, South Korea, 52727
        • Gyeongsang National University Hospital ( Site 1005)
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Chungbuk National University Hospital ( Site 1002)
    • Seoul
      • Songpa-gu, Seoul, South Korea, 05505
        • Asan Medical Center ( Site 1007)
  • Spain
      • Barcelona, Spain, 08041
        • Hospital Sant Creu i Sant Pau ( Site 1711)
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre ( Site 1716)
      • Málaga, Spain, 29010
        • Complejo Hospitalario de Malaga ( Site 1714)
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena ( Site 1712)
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Hospital Duran i Reynals ( Site 1710)
    • La Coruna
      • Jaén, La Coruna, Spain, 23007
        • Complejo Hospitalario de Jaen ( Site 1713)
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)
      • Taichung, Taiwan, 40447
        • China Medical University Hospital ( Site 0904)
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital ( Site 0905)
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital ( Site 0900)
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital ( Site 0902)
      • Taoyuan District, Taiwan, 333
        • Chang Gung Medical Foundation.Linkou Branch ( Site 0903)
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01120
        • Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)
      • Ankara, Turkey (Türkiye), 06500
        • Gazi Universitesi Tip Fakultesi ( Site 2104)
      • Ankara, Turkey (Türkiye), 06800
        • Ankara Sehir Hastanesi ( Site 2105)
      • Istanbul, Turkey (Türkiye), 34093
        • Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)
      • Istanbul, Turkey (Türkiye), 34722
        • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)
      • Izmir, Turkey (Türkiye), 35040
        • Ege Universitesi Tip Fakultesi ( Site 2109)
      • Kayseri, Turkey (Türkiye), 38039
        • Erciyes Universitesi Tip Fakultesi ( Site 2108)
      • Samsun, Turkey (Türkiye), 55270
        • Ondokuz Mays Üniversitesi Tp Fakültesi Hastanesi-Oncology ( Site 2106)
    • Tekirdas
      • Tekirdağ, Tekirdas, Turkey (Türkiye), 59100
        • Namik Kemal Universitesi Tip Fakultesi ( Site 2100)
  • Ukraine
      • Kyiv, Ukraine, 03039
        • Medical Center Verum ( Site 2228)
    • Cherkasy Oblast
      • Cherkasy, Cherkasy Oblast, Ukraine, 18009
        • Cherkasy Regional Oncology Dispensary ( Site 2225)
    • Dnipropetrovsk Oblast
      • Dnipro, Dnipropetrovsk Oblast, Ukraine, 49102
        • City Clinical Hosp.4 of DCC ( Site 2215)
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
        • MI Precarpathian Clinical Oncology Center ( Site 2218)
    • Kharkivs’ka Oblast’
      • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61024
        • Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2226)
      • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61070
        • Regional Centre of Oncology-Thoracic organs ( Site 2219)
    • Kirovohrad Oblast
      • Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25006
        • PP PPC Acinus Medical and Diagnostic Centre ( Site 2223)
    • Kyivska Oblast
      • Khodosovka, Kyivska Oblast, Ukraine, 08173
        • Medical Center Asklepion LLC ( Site 2243)
      • Kyiv, Kyivska Oblast, Ukraine, 03115
        • Kyiv City Clinical Oncology Centre ( Site 2224)
      • Kyiv, Kyivska Oblast, Ukraine, 03126
        • Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2227)
    • Odesa Oblast
      • Odesa, Odesa Oblast, Ukraine, 65055
        • MI Odessa Regional Oncological Centre ( Site 2222)
    • Zakarpattia Oblast
      • Uzhhorod, Zakarpattia Oblast, Ukraine, 88000
        • Central City Clinical Hospital ( Site 2221)
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital ( Site 1910)
    • Essex
      • Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY
        • Southend University Hospital NHS Foundation Trust ( Site 1913)
    • London, City of
      • London, London, City of, United Kingdom, EC1M 6BQ
        • Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)
      • London, London, City of, United Kingdom, SW10 9NH
        • Chelsea and Westminster Hospital ( Site 1901)
    • Newcastle Upon Tyne
      • Newcastle upon Tyne, Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Newcastle Freeman Hospital ( Site 1902)
    • Suffolk
      • Bury St Edmunds, Suffolk, United Kingdom, IP33 2QZ
        • West Suffolk Hospitals NHS Trust ( Site 1919)
    • United Kingdom
      • Edinburgh, United Kingdom, United Kingdom, EH4 2XU
        • Western General Hospital, Edinburgh ( Site 1924)
    • Wales
      • Swansea, Wales, United Kingdom, SA2 8QA
        • Singleton Hospital ( Site 1909)
    • Worcestershire
      • Colchester, Worcestershire, United Kingdom, CO4 5JL
        • Colchester General Hospital ( Site 1911)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Alabama Oncology Bruno Cancer Center ( Site 0001)
    • California
      • Burbank, California, United States, 91505
        • Disney Family Cancer Center ( Site 0005)
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Regional Hospital ( Site 0018)
      • Orange City, Florida, United States, 32763
        • Mid-Florida Cancer Centers ( Site 0022)
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute ( Site 0024)
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Research Institute ( Site 0099)
    • Illinois
      • Chicago, Illinois, United States, 60608
        • Mount Sinai Hospital Medical Center ( Site 0035)
      • Rolling Meadows, Illinois, United States, 60008
        • Oncology of Northshore ( Site 0036)
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039)
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • MedStar Franklin Square Medical Center ( Site 0044)
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute ( Site 0046)
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic ( Site 0051)
    • Montana
      • Billings, Montana, United States, 59102
        • Frontier Oncology ( Site 0052)
      • Bozeman, Montana, United States, 59715
        • Bozeman Health Deaconness Cancer Center ( Site 0053)
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Waverly Hematology Oncology ( Site 0054)
    • Tennessee
      • Knoxville, Tennessee, United States, 37804
        • Thompson Cancer Survival Center ( Site 2812)
    • Texas
      • The Woodlands, Texas, United States, 77380
        • Renovatio Clinical ( Site 0074)
    • Washington
      • Spokane Valley, Washington, United States, 99216
        • Cancer Care Northwest ( Site 0083)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
  2. Have Stage IV squamous NSCLC.
  3. Have measurable disease based on RECIST 1.1.
  4. Have not received prior systemic treatment for their advanced/metastatic NSCLC.

  5. 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.

  6. 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
  7. Have a life expectancy of at least 3 months.
  8. Has adequate organ function.
  9. 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.
  10. Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.

Exclusion Criteria:

  1. Has non-squamous histology NSCLC.
  2. Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
  3. Has known active central nervous system metastases and/or carcinomatous meningitis.
  4. Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib.
  5. Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  6. Has an active autoimmune disease that has required systemic treatment in past 2 years.
  7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
  8. Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
  9. Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
  10. Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
  11. Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
  12. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab + Carboplatin + Taxane + Olaparib

For the Induction Phase, participants receive 4 cycles:

Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy.

For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
Drug: Paclitaxel
IV infusion
Other Names:
  • TAXOL®
  • ONXAL™
Drug: Nab-paclitaxel
IV infusion
Other Names:
  • ABRAXANE®
Drug: Carboplatin
IV infusion
Other Names:
  • PARAPLATIN®
Drug: Olaparib
Tablets
Other Names:
  • LYNPARZA®
Active Comparator: Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo

For the Induction Phase, participants receive 4 cycles:

Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy.

For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
Drug: Paclitaxel
IV infusion
Other Names:
  • TAXOL®
  • ONXAL™
Drug: Nab-paclitaxel
IV infusion
Other Names:
  • ABRAXANE®
Drug: Carboplatin
IV infusion
Other Names:
  • PARAPLATIN®
Drug: Placebo
Placebo to olaparib, tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: Up to approximately 39 months
Progression-free Survival was defined as the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, progressive disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 is presented. PFS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 39 months
Overall Survival (OS)
Time Frame: Up to approximately 46 months
Overall survival was the time from the date of randomization to death due to any cause. OS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 46 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With One or More Adverse Events (AEs)
Time Frame: Up to approximately 4 years
An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The number of participants who reported 1 or more AEs is presented. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 4 years
Number of Participants Who Discontinued Study Intervention Due to an AE
Time Frame: Up to approximately 4 years
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The number of participants who discontinued study intervention due to an AE is presented. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 4 years
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/ Quality of Life (QoL) (Items 29 and 30) Combined Scale Score
Time Frame: Baseline and Week 24
EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the Global Health Status GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were each scored on a 7-point scale (1=Very Poor to 7=Excellent), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score was assessed using a constrained longitudinal data analysis (cLDA) model with the patient-reported outcome (PRO) score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Baseline and Week 24
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 and 30) Scale Score
Time Frame: Up to approximately 2 years
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Item 29) and QoL score (EORTC QLQ-C30 Item 30). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10- point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 2 years
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
Time Frame: Baseline and Week 24
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Baseline and Week 24
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
Time Frame: Up to approximately 2 years
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough scale score. The TTD for cough (Item 1) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 2 years
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
Time Frame: Baseline and Week 24
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Baseline and Week 24
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
Time Frame: Up to approximately 2 years
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in chest pain scale score. The TTD for chest pain (Item 10) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 2 years
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
Time Frame: Baseline and Week 24
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score will be presented. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Baseline and Week 24
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
Time Frame: Up to approximately 2 years
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Item 8 scale score. The TTD for dyspnea (Item 8) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 2 years
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
Time Frame: Baseline and Week 24
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score is presented. Change from baseline score was assessed using a constrained longitudinal data analysis (cLDA) model with the patient-reported outcome (PRO) score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Baseline and Week 24
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
Time Frame: Up to approximately 2 years
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores. The TTD for physical functioning (Item 1-5) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2019

Primary Completion (Actual)

September 21, 2023

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

June 3, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7339-008
  • MK-7339-008 (Other Identifier: MSD Protocol Number)
  • KEYLYNK-008 (Other Identifier: MSD)
  • 194894 (Registry Identifier: JAPIC-CTI)
  • 2018-004721-88 (EudraCT Number)
  • 2023-508449-41-00 (Registry Identifier: EU CT)
  • U1111-1298-1950 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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