AzTrials
AzTrials

Carcinoma, Squamous Cell, Non-small-cell LungPhase 3NCT03976362

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)

A Phase 3 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Carcinoma, Squamous Cell, Non-small-cell Lung, run by Merck Sharp & Dohme LLC at 178 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab, Carboplatin and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
851 participants
Where
178 sitesin 20 countries
Study dates
28 Jun 2019to 30 Jan 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Has non-squamous histology NSCLC.
  • Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
  • Has known active central nervous system metastases and/or carcinomatous meningitis.
  • Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib.
  • Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
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  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
  • Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
  • Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
  • Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
  • 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).
  • Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.

Trial locations and contacts

178 sites in 20 countries.

178 sites in 20 countries

United States18 sites

  • MedStar Franklin Square Medical Center ( Site 0044)

    Baltimore, Maryland, 21237

  • Frontier Oncology ( Site 0052)

    Billings, Montana, 59102

  • Alabama Oncology Bruno Cancer Center ( Site 0001)

    Birmingham, Alabama, 35205

  • Boca Raton Regional Hospital ( Site 0018)

    Boca Raton, Florida, 33486

  • Bozeman Health Deaconness Cancer Center ( Site 0053)

    Bozeman, Montana, 59715

  • Disney Family Cancer Center ( Site 0005)

    Burbank, California, 91505

  • Waverly Hematology Oncology ( Site 0054)

    Cary, North Carolina, 27518

  • Mount Sinai Hospital Medical Center ( Site 0035)

    Chicago, Illinois, 60608

  • Columbus Regional Research Institute ( Site 0099)

    Columbus, Georgia, 31904

  • Barbara Ann Karmanos Cancer Institute ( Site 0046)

    Detroit, Michigan, 48201

  • Hattiesburg Clinic ( Site 0051)

    Hattiesburg, Mississippi, 39401

  • Thompson Cancer Survival Center ( Site 2812)

    Knoxville, Tennessee, 37804

  • Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039)

    Merrillville, Indiana, 46410

  • Mid-Florida Cancer Centers ( Site 0022)

    Orange City, Florida, 32763

  • Oncology of Northshore ( Site 0036)

    Rolling Meadows, Illinois, 60008

  • Cancer Care Northwest ( Site 0083)

    Spokane Valley, Washington, 99216

  • H. Lee Moffitt Cancer Center and Research Institute ( Site 0024)

    Tampa, Florida, 33612

  • Renovatio Clinical ( Site 0074)

    The Woodlands, Texas, 77380

Other trials in United States

Japan15 sites

  • National Hospital Organization Kyushu Medical Center ( Site 0805)

    Fukuoka, 810-8563

  • Kansai Medical University Hospital ( Site 0804)

    Hirakata, Osaka, 573-1191

  • Kanazawa University Hospital ( Site 0811)

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East ( Site 0801)

    Kashiwa, Chiba, 277-8577

  • Kurume University Hospital ( Site 0814)

    Kurume, Fukuoka, 830-0011

  • National Hospital Organization Nagoya Medical Center ( Site 0806)

    Nagoya, Aichi-ken, 460-0001

  • Aichi Cancer Center Hospital ( Site 0803)

    Nagoya, Aichi-ken, 464-8681

  • Niigata Cancer Center Hospital ( Site 0808)

    Niigata, 951-8566

  • Okayama University Hospital ( Site 0810)

    Okayama, 700-8558

  • Osaka International Cancer Institute ( Site 0809)

    Osaka, 541-8567

  • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)

    Sakai, Osaka, 591-8555

  • Sendai Kousei Hospital ( Site 0812)

    Sendai, Miyagi, 980-0873

  • Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)

    Sunto-gun, Shizuoka, 411-8777

  • The Cancer Institute Hospital of JFCR ( Site 0800)

    Tokyo, 135-8550

  • Kanagawa Cancer Center ( Site 0807)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Germany13 sites

  • Studienzentrum Aschaffenburg ( Site 1575)

    Aschaffenburg, Bavaria, 63739

  • Universitaetsklinikum Bonn ( Site 1574)

    Bonn, North Rhine-Westphalia, 53105

  • Helios Klinikum Erfurt GmbH ( Site 1552)

    Erfurt, Thuringia, 99089

  • Kliniken Essen Mitte ( Site 1567)

    Essen, North Rhine-Westphalia, 45136

  • Universitaetsklinikum Frankfurt ( Site 1563)

    Frankfurt am Main, Hesse, 60590

  • Universitaetsmedizin Goettingen ( Site 1557)

    Göttingen, Lower Saxony, 37075

  • Katholisches Marienkrankenhaus gGmbH ( Site 1572)

    Hamburg, 22087

  • Pneumologische Lehrklinik Universitaet Goettingen ( Site 1551)

    Immenhausen, Hesse, 34376

  • InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1564)

    Koblenz, Rhineland-Palatinate, 56068

  • Klinikum der LMU ( Site 1550)

    Munich, Bavaria, 80336

  • Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1573)

    Munich, Bavaria, 81925

  • Universitaetsklinikum Regensburg ( Site 1562)

    Regensburg, Bavaria, 93042

  • Klinikum Wuerzburg Mitte gGmbH ( Site 1559)

    Würzburg, Bavaria, 97074

Other trials in Germany

Russia13 sites

  • Moscow Regional Oncological Dispensary ( Site 2028)

    Balashikha, Moscow Oblast, 143900

  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021)

    Kazan', Tatarstan, Respublika, 420029

  • Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)

    Moscow, Moscow, 115478

  • First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)

    Moscow, Moscow, 119991

  • Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)

    Moscow, Moscow, 125284

  • FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)

    Moscow, Moscow, 125367

  • Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603081

  • Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site

    Omsk, Omsk Oblast, 644013

  • SBHI Leningrad Regional Clinical Hospital ( Site 2002)

    Saint Petersburg, Sankt-Peterburg, 194291

  • SPb Central Clinical Railway Hospital ( Site 2003)

    Saint Petersburg, Sankt-Peterburg, 195271

  • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)

    Saint Petersburg, Sankt-Peterburg, 197758

  • SPb SBHI City Clinical Oncological Dispensary ( Site 2001)

    Saint Petersburg, Sankt-Peterburg, 198255

  • SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)

    Samara, Samara Oblast, 443031

Other trials in Russia

Ukraine12 sites

  • Cherkasy Regional Oncology Dispensary ( Site 2225)

    Cherkasy, Cherkasy Oblast, 18009

  • City Clinical Hosp.4 of DCC ( Site 2215)

    Dnipro, Dnipropetrovsk Oblast, 49102

  • MI Precarpathian Clinical Oncology Center ( Site 2218)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2226)

    Kharkiv, Kharkiv Oblast, 61024

  • Regional Centre of Oncology-Thoracic organs ( Site 2219)

    Kharkiv, Kharkiv Oblast, 61070

  • Medical Center Asklepion LLC ( Site 2243)

    Khodosovka, Kyivska Oblast, 08173

  • PP PPC Acinus Medical and Diagnostic Centre ( Site 2223)

    Kropyvnytskyi, Kirovohrad Oblast, 25006

  • Kyiv City Clinical Oncology Centre ( Site 2224)

    Kyiv, Kyivska Oblast, 03115

  • Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2227)

    Kyiv, Kyivska Oblast, 03126

  • Medical Center Verum ( Site 2228)

    Kyiv, 03039

  • MI Odessa Regional Oncological Centre ( Site 2222)

    Odesa, Odesa Oblast, 65055

  • Central City Clinical Hospital ( Site 2221)

    Uzhhorod, Zakarpattia Oblast, 88000

Other trials in Ukraine

Brazil11 sites

  • Oncologica do Brasil ( Site 0256)

    Belém, Pará, 66053-000

  • Hospital Tacchini ( Site 0265)

    Bento Gonçalves, Rio Grande do Sul, 95700-000

  • Instituto do Cancer do Ceara ( Site 0251)

    Fortaleza, Ceará, 60430-230

  • Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0252)

    Itajaí, Santa Catarina, 88301-220

  • Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0255)

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0253)

    Rio de Janeiro, 20230-130

  • Hospital Sao Rafael ( Site 0258)

    Salvador - BA, Estado de Bahia, 41253-190

  • Hospital de Base de Sao Jose de Rio Preto ( Site 0254)

    Sao Jose Rio Preto, São Paulo, 15090-000

  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0250)

    São Paulo, 01246-000

  • Hospital Paulistano - Amil Clinical Research ( Site 0263)

    São Paulo, 01321-001

  • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0260)

    São Paulo, 01321-001

Other trials in Brazil

Argentina10 sites

  • Hospital Italiano Regional del Sur ( Site 0509)

    Bahía Blanca, Buenos Aires, B8001HXM

  • Hospital Britanico de Buenos Aires ( Site 0500)

    Buenos Aires, Buenos Aires F.D., C1280AEB

  • Hospital Italiano de Buenos Aires ( Site 0511)

    Buenos Aires, C1199ABB

  • Clínica Universitaria Reina Fabiola ( Site 0505)

    Córdoba, X5004FHP

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516)

    Mar del Plata, Buenos Aires, B7600FZO

  • Instituto Medico Rio Cuarto ( Site 0501)

    Río Cuarto, Córdoba Province, X5800AEV

  • Sanatorio Parque ( Site 0515)

    Rosario, Santa Fe Province, S2000DSV

  • Centro Oncológico de Rosario ( Site 0507)

    Rosario, Santa Fe Province, S2000KZE

  • Centro Medico San Roque ( Site 0506)

    San Miguel de Tucumán, Tucumán Province, T4000IAK

  • Sanatorio Privado San Geronimo S.R.L ( Site 0510)

    Santa Fe, S3000AOL

Other trials in Argentina

France9 sites

  • CHU Angers ( Site 1405)

    Angers, Maine-et-Loire, 49100

  • CHU Caen ( Site 1406)

    Caen, Calvados, 14033

  • Centre Hospitalier De Chauny ( Site 1411)

    Chauny, Aisne, 02300

  • Centre Jean Perrin ( Site 1407)

    Clermont-Ferrand, Puy-de-Dome, 63011

  • Centre Hospitalier de Pau ( Site 1412)

    Pau, Pyrenees-Atlantiques, 64000

  • CHU de Rouen ( Site 1403)

    Rouen, Seine-Maritime, 76000

  • Hopital d'Instruction des Armees Begin ( Site 1413)

    Saint-Mandé, Val-de-Marne, 94163

  • Institut De Cancerologie De Lorraine ( Site 1409)

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54519

  • Hopital Robert Schuman ( Site 1402)

    Vantoux, Moselle, 57070

Other trials in France

South Korea9 sites

  • Chungbuk National University Hospital ( Site 1002)

    Cheongju-si, North Chungcheong, 28644

  • National Cancer Center ( Site 1006)

    Goyang-si, Kyonggi-do, 10408

  • The Catholic University of Korea St. Vincent s Hospital ( Site 1003)

    Gyeonggi-do, Kyonggi-do, 16247

  • Gyeongsang National University Hospital ( Site 1005)

    Jinju, Kyongsangnam-do, 52727

  • Seoul National University Hospital ( Site 1000)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 1001)

    Seoul, 03722

  • Korea University Guro Hospital ( Site 1008)

    Seoul, 08308

  • Asan Medical Center ( Site 1007)

    Songpa-gu, Seoul, 05505

  • Ajou University Hospital ( Site 1004)

    Suwon, Kyonggi-do, 16499

Other trials in South Korea

Turkey (Türkiye)9 sites

  • Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)

    Adana, 01120

  • Gazi Universitesi Tip Fakultesi ( Site 2104)

    Ankara, 06500

  • Ankara Sehir Hastanesi ( Site 2105)

    Ankara, 06800

  • Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)

    Istanbul, 34093

  • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)

    Istanbul, 34722

  • Ege Universitesi Tip Fakultesi ( Site 2109)

    Izmir, 35040

  • Erciyes Universitesi Tip Fakultesi ( Site 2108)

    Kayseri, 38039

  • Ondokuz Mays Üniversitesi Tp Fakültesi Hastanesi-Oncology ( Site 2106)

    Samsun, 55270

  • Namik Kemal Universitesi Tip Fakultesi ( Site 2100)

    Tekirdağ, Tekirdas, 59100

Other trials in Turkey (Türkiye)

United Kingdom9 sites

  • Birmingham Heartlands Hospital ( Site 1910)

    Birmingham, B9 5SS

  • West Suffolk Hospitals NHS Trust ( Site 1919)

    Bury St Edmunds, Suffolk, IP33 2QZ

  • Colchester General Hospital ( Site 1911)

    Colchester, Worcestershire, CO4 5JL

  • Western General Hospital, Edinburgh ( Site 1924)

    Edinburgh, United Kingdom, EH4 2XU

  • Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)

    London, London, City of, EC1M 6BQ

  • Chelsea and Westminster Hospital ( Site 1901)

    London, London, City of, SW10 9NH

  • Newcastle Freeman Hospital ( Site 1902)

    Newcastle upon Tyne, Newcastle Upon Tyne, NE7 7DN

  • Singleton Hospital ( Site 1909)

    Swansea, Wales, SA2 8QA

  • Southend University Hospital NHS Foundation Trust ( Site 1913)

    Westcliff-on-Sea, Essex, SS0 0RY

Other trials in United Kingdom

Canada8 sites

  • CISSS de la Monteregie-Centre ( Site 0101)

    Greenfield Park, Quebec, J4V 2H1

  • Nova Scotia Health Authority ( Site 0103)

    Halifax, Nova Scotia, B3H 1V7

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0107)

    Hamilton, Ontario, L8V5C2

  • Kingston Health Sciences Centre ( Site 0102)

    Kingston, Ontario, K7L 2V7

  • Hopital Cite de la Sante de Laval ( Site 0105)

    Laval, Quebec, H7M 3L9

  • CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)

    Montreal, Quebec, H3T 1M5

  • Stronach Regional Cancer Centre ( Site 0100)

    Newmarket, Ontario, L3Y 2P9

  • CIUSSS de la Mauricie et du Centre du Quebec ( Site 0106)

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

Poland7 sites

  • Przychodnia Lekarska Komed ( Site 2416)

    Konin, Greater Poland Voivodeship, 62-500

  • Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)

    Krakow, Lesser Poland Voivodeship, 31-202

  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)

    Olsztyn, Lower Silesian Voivodeship, 10-357

  • MED-POLONIA Sp. z o.o. ( Site 2419)

    Poznan, Greater Poland Voivodeship, 60-693

  • Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)

    Racibórz, Silesian Voivodeship, 47-400

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

    Warsaw, Masovian Voivodeship, 02-781

  • Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)

    Zgorzelec, Lower Silesian Voivodeship, 59-900

Other trials in Poland

Mexico6 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0334)

    Guadalajara, Jalisco, 44280

  • Investigacion Onco Farmaceutica S de RL de CV ( Site 0300)

    La Paz, Baja California Sur, 23040

  • Arke Estudios Clinicos ( Site 0333)

    Mexico City, Mexico City, 06700

  • Axis Heilsa S. de R.L. de C.V. ( Site 0301)

    Monterrey, Nuevo León, 64060

  • CLIMERS Clinical Medical Research ( Site 0306)

    Orizaba, Veracruz, 94300

  • FAICIC Clinical Research ( Site 0303)

    Veracruz, 91900

Other trials in Mexico

Romania6 sites

  • S.C.Focus Lab Plus S.R.L ( Site 2502)

    Bucharest, 022548

  • Cardiomed SRL Cluj-Napoca ( Site 2504)

    Cluj-Napoca, Cluj, 400015

  • S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)

    Cluj-Napoca, Cluj, 407280

  • Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei ( Site 2501)

    Constanța, 900591

  • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)

    Craiova, Dolj, 200347

  • Policlinica Oncomed SRL ( Site 2505)

    Timișoara, Timiș County, 300239

Other trials in Romania

Spain6 sites

  • Hospital Sant Creu i Sant Pau ( Site 1711)

    Barcelona, 08041

  • Complejo Hospitalario de Jaen ( Site 1713)

    Jaén, La Coruna, 23007

  • Hospital Duran i Reynals ( Site 1710)

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario 12 de Octubre ( Site 1716)

    Madrid, 28041

  • Complejo Hospitalario de Malaga ( Site 1714)

    Málaga, 29010

  • Hospital Universitario Virgen Macarena ( Site 1712)

    Seville, 41009

Other trials in Spain

Taiwan6 sites

  • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)

    Kaohsiung City, 83301

  • China Medical University Hospital ( Site 0904)

    Taichung, 40447

  • National Cheng Kung University Hospital ( Site 0905)

    Tainan, 704

  • National Taiwan University Hospital ( Site 0900)

    Taipei, 10048

  • Mackay Memorial Hospital ( Site 0902)

    Taipei, 104

  • Chang Gung Medical Foundation.Linkou Branch ( Site 0903)

    Taoyuan, 333

Other trials in Taiwan

Austria5 sites

  • Innsbruck LKH ( Site 1302)

    Innsbruck, Tyrol, 6020

  • Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)

    Linz, Upper Austria, 4020

  • Social Medical Center - Otto Wagner Hospital ( Site 1301)

    Vienna, State of Vienna, 1145

  • Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)

    Vienna, 1210

  • Klinikum Wels-Grieskirchen ( Site 1304)

    Wels, Upper Austria, 4600

Other trials in Austria

Australia4 sites

  • Monash Cancer Centre ( Site 1205)

    Clayton, Victoria, 3168

  • Liverpool Hospital ( Site 1201)

    Liverpool, New South Wales, 2170

  • Townsville General Hospital ( Site 1202)

    Townsville, Queensland, 4814

  • Southern Medical Day Care Centre ( Site 1200)

    Wollongong, New South Wales, 2500

Other trials in Australia

New Zealand2 sites

  • MidCentral DHB Palmerston North Hospital ( Site 1102)

    Palmerston North, Manawatu-Wanganui, 4414

  • Capital & Coast District Health Board - Wellington Hospital ( Site 1101)

    Wellington, 6021

Other trials in New Zealand

About this study

Official title: 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.

Read the 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.

Keywords
PD-1, PD L1, PD L2
Medical subject headings
Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475

    IV infusion

  • CarboplatinDrug

    Also called PARAPLATIN®

    IV infusion

  • PaclitaxelDrug

    Also called TAXOL®, ONXAL™

    IV infusion

  • Nab-paclitaxelDrug

    Also called ABRAXANE®

    IV infusion

  • OlaparibDrug

    Also called LYNPARZA®

    Tablets

  • PlaceboDrug

    Placebo to olaparib, tablets

Study groups in NCT03976362
Study groupRoleWhat they receive
Pembrolizumab + Carboplatin + Taxane + OlaparibExperimentalFor 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.
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Olaparib
Pembrolizumab + Carboplatin + Taxane + Olaparib PlaceboActive comparatorFor 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.
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    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.

    Measured: Up to approximately 39 months

  2. Overall Survival (OS)

    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.

    Measured: Up to approximately 46 months

Secondary outcomes (12)

  1. Number of Participants With One or More Adverse Events (AEs)

    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.

    Measured: Up to approximately 4 years

  2. Number of Participants Who Discontinued Study Intervention Due to an AE

    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.

    Measured: Up to approximately 4 years

  3. 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

    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.

    Measured: Baseline and Week 24

  4. 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

    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.

    Measured: Up to approximately 2 years

  5. 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

    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.

    Measured: Baseline and Week 24

  6. 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

    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.

    Measured: Up to approximately 2 years

  7. 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

    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.

    Measured: Baseline and Week 24

  8. 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

    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.

    Measured: Up to approximately 2 years

  9. 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

    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.

    Measured: Baseline and Week 24

  10. 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

    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.

    Measured: Up to approximately 2 years

  11. 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

    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.

    Measured: Baseline and Week 24

  12. 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

    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.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2019
  2. Study start28 Jun 2019
  3. Primary completion21 Sep 2023
  4. Study completion30 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
851 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03976362
Sponsor's protocol ID
7339-008
Other IDs
MK-7339-008, KEYLYNK-008, 194894, 2023-508449-41-00, U1111-1298-1950, 2018-004721-88, 2018, 2023
Status last verified
Feb 2026
First submitted
3 Jun 2019
Last updated
25 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Hochmair M, Schenker M, Cobo Dols M, Kim TM, Ozyilkan O, Smagina M, Leonova V, Kato T, Fedenko A, De Angelis F, Rittmeyer A, Gray JE, Greystoke A, Aggarwal H, Huang Q, Zhao B, Lara-Guerra H, Nadal E. Pembrolizumab With or Without Maintenance Olaparib for Metastatic Squamous NSCLC That Responded to First-Line Pembrolizumab Plus Chemotherapy. J Thorac Oncol. 2025 Feb;20(2):203-218. doi: 10.1016/j.jtho.2024.10.012. Epub 2024 Oct 28.

    PubMed 39477187

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Carcinoma, Squamous Cell, Non-small-cell Lung, run by Merck Sharp & Dohme LLC at 178 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in United States, Japan, Germany, Russia, Ukraine and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Up to approximately 39 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03976362, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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