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)

NCT ID: NCT03976362

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 851 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-28
• Study Completion Date: 2026-01-30

Brief 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. 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.

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.

Conditions

Carcinoma, Squamous Cell, Non-small-cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion

Carboplatin

Intervention Type: DRUG

IV infusion

Paclitaxel

Intervention Type: DRUG

IV infusion

Nab-paclitaxel

Intervention Type: DRUG

IV infusion

Olaparib

Intervention Type: DRUG

Tablets

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.

Group Type: ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion

Carboplatin

Intervention Type: DRUG

IV infusion

Paclitaxel

Intervention Type: DRUG

IV infusion

Nab-paclitaxel

Intervention Type: DRUG

IV infusion

Placebo

Intervention Type: DRUG

Placebo to olaparib, tablets

Interventions

Pembrolizumab

IV infusion

Intervention Type: BIOLOGICAL

Carboplatin

IV infusion

Intervention Type: DRUG

Paclitaxel

IV infusion

Intervention Type: DRUG

Nab-paclitaxel

IV infusion

Intervention Type: DRUG

Olaparib

Tablets

Intervention Type: DRUG

Placebo

Placebo to olaparib, tablets

Intervention Type: DRUG

Other Intervention Names

MK-3475; PARAPLATIN®; TAXOL®; ONXAL™; ABRAXANE®; LYNPARZA®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Alabama Oncology Bruno Cancer Center ( Site 0001)

Birmingham, Alabama, United States

Disney Family Cancer Center ( Site 0005)

Burbank, California, United States

Boca Raton Regional Hospital ( Site 0018)

Boca Raton, Florida, United States

Mid-Florida Cancer Centers ( Site 0022)

Orange City, Florida, United States

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

Tampa, Florida, United States

Columbus Regional Research Institute ( Site 0099)

Columbus, Georgia, United States

Mount Sinai Hospital Medical Center ( Site 0035)

Chicago, Illinois, United States

Oncology of Northshore ( Site 0036)

Rolling Meadows, Illinois, United States

Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039)

Merrillville, Indiana, United States

MedStar Franklin Square Medical Center ( Site 0044)

Baltimore, Maryland, United States

Barbara Ann Karmanos Cancer Institute ( Site 0046)

Detroit, Michigan, United States

Hattiesburg Clinic ( Site 0051)

Hattiesburg, Mississippi, United States

Frontier Oncology ( Site 0052)

Billings, Montana, United States

Bozeman Health Deaconness Cancer Center ( Site 0053)

Bozeman, Montana, United States

Waverly Hematology Oncology ( Site 0054)

Cary, North Carolina, United States

Thompson Cancer Survival Center ( Site 2812)

Knoxville, Tennessee, United States

Renovatio Clinical ( Site 0074)

The Woodlands, Texas, United States

Cancer Care Northwest ( Site 0083)

Spokane Valley, Washington, United States

Hospital Italiano Regional del Sur ( Site 0509)

Bahía Blanca, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516)

Mar del Plata, Buenos Aires, Argentina

Hospital Britanico de Buenos Aires ( Site 0500)

Buenos Aires, Buenos Aires F.D., Argentina

Instituto Medico Rio Cuarto ( Site 0501)

Río Cuarto, Córdoba Province, Argentina

Sanatorio Parque ( Site 0515)

Rosario, Santa Fe Province, Argentina

Centro Oncológico de Rosario ( Site 0507)

Rosario, Santa Fe Province, Argentina

Centro Medico San Roque ( Site 0506)

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Italiano de Buenos Aires ( Site 0511)

Buenos Aires, , Argentina

Clínica Universitaria Reina Fabiola ( Site 0505)

Córdoba, , Argentina

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

Santa Fe, , Argentina

Liverpool Hospital ( Site 1201)

Liverpool, New South Wales, Australia

Southern Medical Day Care Centre ( Site 1200)

Wollongong, New South Wales, Australia

Townsville General Hospital ( Site 1202)

Townsville, Queensland, Australia

Monash Cancer Centre ( Site 1205)

Clayton, Victoria, Australia

Innsbruck LKH ( Site 1302)

Innsbruck, Tyrol, Austria

Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)

Linz, Upper Austria, Austria

Klinikum Wels-Grieskirchen ( Site 1304)

Wels, Upper Austria, Austria

Social Medical Center - Otto Wagner Hospital ( Site 1301)

Vienna, Vienna, Austria

Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)

Vienna, , Austria

Instituto do Cancer do Ceara ( Site 0251)

Fortaleza, Ceará, Brazil

Hospital Sao Rafael ( Site 0258)

Salvador - BA, Estado de Bahia, Brazil

Oncologica do Brasil ( Site 0256)

Belém, Pará, Brazil

Hospital Tacchini ( Site 0265)

Bento Gonçalves, Rio Grande do Sul, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

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

Itajaí, Santa Catarina, Brazil

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

Sao Jose Rio Preto, São Paulo, Brazil

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

Rio de Janeiro, , Brazil

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

São Paulo, , Brazil

Hospital Paulistano - Amil Clinical Research ( Site 0263)

São Paulo, , Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0260)

São Paulo, , Brazil

Nova Scotia Health Authority ( Site 0103)

Halifax, Nova Scotia, Canada

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0107)

Hamilton, Ontario, Canada

Kingston Health Sciences Centre ( Site 0102)

Kingston, Ontario, Canada

Stronach Regional Cancer Centre ( Site 0100)

Newmarket, Ontario, Canada

CISSS de la Monteregie-Centre ( Site 0101)

Greenfield Park, Quebec, Canada

Hopital Cite de la Sante de Laval ( Site 0105)

Laval, Quebec, Canada

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

Montreal, Quebec, Canada

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

Trois-Rivières, Quebec, Canada

Centre Hospitalier De Chauny ( Site 1411)

Chauny, Aisne, France

CHU Caen ( Site 1406)

Caen, Calvados, France

CHU Angers ( Site 1405)

Angers, Maine-et-Loire, France

Institut De Cancerologie De Lorraine ( Site 1409)

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

Hopital Robert Schuman ( Site 1402)

Vantoux, Moselle, France

Centre Jean Perrin ( Site 1407)

Clermont-Ferrand, Puy-de-Dome, France

Centre Hospitalier de Pau ( Site 1412)

Pau, Pyrenees-Atlantiques, France

CHU de Rouen ( Site 1403)

Rouen, Seine-Maritime, France

Hopital d'Instruction des Armees Begin ( Site 1413)

Saint-Mandé, Val-de-Marne, France

Studienzentrum Aschaffenburg ( Site 1575)

Aschaffenburg, Bavaria, Germany

Klinikum der LMU ( Site 1550)

Munich, Bavaria, Germany

Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1573)

Munich, Bavaria, Germany

Universitaetsklinikum Regensburg ( Site 1562)

Regensburg, Bavaria, Germany

Klinikum Wuerzburg Mitte gGmbH ( Site 1559)

Würzburg, Bavaria, Germany

Universitaetsklinikum Frankfurt ( Site 1563)

Frankfurt am Main, Hesse, Germany

Pneumologische Lehrklinik Universitaet Goettingen ( Site 1551)

Immenhausen, Hesse, Germany

Universitaetsmedizin Goettingen ( Site 1557)

Göttingen, Lower Saxony, Germany

Universitaetsklinikum Bonn ( Site 1574)

Bonn, North Rhine-Westphalia, Germany

Kliniken Essen Mitte ( Site 1567)

Essen, North Rhine-Westphalia, Germany

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

Koblenz, Rhineland-Palatinate, Germany

Helios Klinikum Erfurt GmbH ( Site 1552)

Erfurt, Thuringia, Germany

Katholisches Marienkrankenhaus gGmbH ( Site 1572)

Hamburg, , Germany

National Hospital Organization Nagoya Medical Center ( Site 0806)

Nagoya, Aichi-ken, Japan

Aichi Cancer Center Hospital ( Site 0803)

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East ( Site 0801)

Kashiwa, Chiba, Japan

Kurume University Hospital ( Site 0814)

Kurume, Fukuoka, Japan

Kanazawa University Hospital ( Site 0811)

Kanazawa, Ishikawa-ken, Japan

Kanagawa Cancer Center ( Site 0807)

Yokohama, Kanagawa, Japan

Sendai Kousei Hospital ( Site 0812)

Sendai, Miyagi, Japan

Kansai Medical University Hospital ( Site 0804)

Hirakata, Osaka, Japan

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

Sakai, Osaka, Japan

Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)

Sunto-gun, Shizuoka, Japan

National Hospital Organization Kyushu Medical Center ( Site 0805)

Fukuoka, , Japan

Niigata Cancer Center Hospital ( Site 0808)

Niigata, , Japan

Okayama University Hospital ( Site 0810)

Okayama, , Japan

Osaka International Cancer Institute ( Site 0809)

Osaka, , Japan

The Cancer Institute Hospital of JFCR ( Site 0800)

Tokyo, , Japan

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

La Paz, Baja California Sur, Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0334)

Guadalajara, Jalisco, Mexico

Arke Estudios Clinicos ( Site 0333)

Mexico City, Mexico City, Mexico

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

Monterrey, Nuevo León, Mexico

CLIMERS Clinical Medical Research ( Site 0306)

Orizaba, Veracruz, Mexico

FAICIC Clinical Research ( Site 0303)

Veracruz, , Mexico

MidCentral DHB Palmerston North Hospital ( Site 1102)

Palmerston North, Manawatu-Wanganui, New Zealand

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

Wellington, , New Zealand

Przychodnia Lekarska Komed ( Site 2416)

Konin, Greater Poland Voivodeship, Poland

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

Poznan, Greater Poland Voivodeship, Poland

Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)

Krakow, Lesser Poland Voivodeship, Poland

Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)

Olsztyn, Lower Silesian Voivodeship, Poland

Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)

Zgorzelec, Lower Silesian Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)

Racibórz, Silesian Voivodeship, Poland

Cardiomed SRL Cluj-Napoca ( Site 2504)

Cluj-Napoca, Cluj, Romania

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

Cluj-Napoca, Cluj, Romania

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

Craiova, Dolj, Romania

Policlinica Oncomed SRL ( Site 2505)

Timișoara, Timiș County, Romania

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

Bucharest, , Romania

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

Constanța, , Romania

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

Moscow, Moscow, Russia

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

Moscow, Moscow, Russia

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

Moscow, Moscow, Russia

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

Moscow, Moscow, Russia

Moscow Regional Oncological Dispensary ( Site 2028)

Balashikha, Moscow Oblast, Russia

Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

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

Omsk, Omsk Oblast, Russia

SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)

Samara, Samara Oblast, Russia

SBHI Leningrad Regional Clinical Hospital ( Site 2002)

Saint Petersburg, Sankt-Peterburg, Russia

SPb Central Clinical Railway Hospital ( Site 2003)

Saint Petersburg, Sankt-Peterburg, Russia

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

Saint Petersburg, Sankt-Peterburg, Russia

SPb SBHI City Clinical Oncological Dispensary ( Site 2001)

Saint Petersburg, Sankt-Peterburg, Russia

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021)

Kazan', Tatarstan, Respublika, Russia

National Cancer Center ( Site 1006)

Goyang-si, Kyonggi-do, South Korea

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

Gyeonggi-do, Kyonggi-do, South Korea

Ajou University Hospital ( Site 1004)

Suwon, Kyonggi-do, South Korea

Gyeongsang National University Hospital ( Site 1005)

Jinju, Kyongsangnam-do, South Korea

Chungbuk National University Hospital ( Site 1002)

Cheongju-si, North Chungcheong, South Korea

Asan Medical Center ( Site 1007)

Songpa-gu, Seoul, South Korea

Seoul National University Hospital ( Site 1000)

Seoul, , South Korea

Severance Hospital Yonsei University Health System ( Site 1001)

Seoul, , South Korea

Korea University Guro Hospital ( Site 1008)

Seoul, , South Korea

Hospital Duran i Reynals ( Site 1710)

L'Hospitalet de Llobregat, Barcelona, Spain

Complejo Hospitalario de Jaen ( Site 1713)

Jaén, La Coruna, Spain

Hospital Sant Creu i Sant Pau ( Site 1711)

Barcelona, , Spain

Hospital Universitario 12 de Octubre ( Site 1716)

Madrid, , Spain

Complejo Hospitalario de Malaga ( Site 1714)

Málaga, , Spain

Hospital Universitario Virgen Macarena ( Site 1712)

Seville, , Spain

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)

Kaohsiung City, , Taiwan

China Medical University Hospital ( Site 0904)

Taichung, , Taiwan

National Cheng Kung University Hospital ( Site 0905)

Tainan City, , Taiwan

National Taiwan University Hospital ( Site 0900)

Taipei, , Taiwan

Mackay Memorial Hospital ( Site 0902)

Taipei, , Taiwan

Chang Gung Medical Foundation.Linkou Branch ( Site 0903)

Taoyuan District, , Taiwan

Namik Kemal Universitesi Tip Fakultesi ( Site 2100)

Tekirdağ, Tekirdas, Turkey (Türkiye)

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

Adana, , Turkey (Türkiye)

Gazi Universitesi Tip Fakultesi ( Site 2104)

Ankara, , Turkey (Türkiye)

Ankara Sehir Hastanesi ( Site 2105)

Ankara, , Turkey (Türkiye)

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

Istanbul, , Turkey (Türkiye)

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

Istanbul, , Turkey (Türkiye)

Ege Universitesi Tip Fakultesi ( Site 2109)

Izmir, , Turkey (Türkiye)

Erciyes Universitesi Tip Fakultesi ( Site 2108)

Kayseri, , Turkey (Türkiye)

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

Samsun, , Turkey (Türkiye)

Cherkasy Regional Oncology Dispensary ( Site 2225)

Cherkasy, Cherkasy Oblast, Ukraine

City Clinical Hosp.4 of DCC ( Site 2215)

Dnipro, Dnipropetrovsk Oblast, Ukraine

MI Precarpathian Clinical Oncology Center ( Site 2218)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

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

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Regional Centre of Oncology-Thoracic organs ( Site 2219)

Kharkiv, Kharkivs’ka Oblast’, Ukraine

PP PPC Acinus Medical and Diagnostic Centre ( Site 2223)

Kropyvnytskyi, Kirovohrad Oblast, Ukraine

Medical Center Asklepion LLC ( Site 2243)

Khodosovka, Kyivska Oblast, Ukraine

Kyiv City Clinical Oncology Centre ( Site 2224)

Kyiv, Kyivska Oblast, Ukraine

Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2227)

Kyiv, Kyivska Oblast, Ukraine

MI Odessa Regional Oncological Centre ( Site 2222)

Odesa, Odesa Oblast, Ukraine

Central City Clinical Hospital ( Site 2221)

Uzhhorod, Zakarpattia Oblast, Ukraine

Medical Center Verum ( Site 2228)

Kyiv, , Ukraine

Southend University Hospital NHS Foundation Trust ( Site 1913)

Westcliff-on-Sea, Essex, United Kingdom

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

London, London, City of, United Kingdom

Chelsea and Westminster Hospital ( Site 1901)

London, London, City of, United Kingdom

Newcastle Freeman Hospital ( Site 1902)

Newcastle upon Tyne, Newcastle Upon Tyne, United Kingdom

West Suffolk Hospitals NHS Trust ( Site 1919)

Bury St Edmunds, Suffolk, United Kingdom

Western General Hospital, Edinburgh ( Site 1924)

Edinburgh, United Kingdom, United Kingdom

Singleton Hospital ( Site 1909)

Swansea, Wales, United Kingdom

Colchester General Hospital ( Site 1911)

Colchester, Worcestershire, United Kingdom

Birmingham Heartlands Hospital ( Site 1910)

Birmingham, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Brazil; Canada; France; Germany; Japan; Mexico; New Zealand; Poland; Romania; Russia; South Korea; Spain; Taiwan; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: RESULT

PMID: 39477187 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26267&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

MK-7339-008

Identifier Type: OTHER

Identifier Source: secondary_id

KEYLYNK-008

Identifier Type: OTHER

Identifier Source: secondary_id

194894

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-508449-41-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1298-1950

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-004721-88

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7339-008

Identifier Type: -

Identifier Source: org_study_id