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)

NCT03976362 | Completed Phase 3 Results DMC FDA Drug

• 7 other identifiers: 7339-008MK-7339-008KEYLYNK-0081948942023-508449-41-00U1111-1298-19502018-004721-88
• Study Type: interventional
• Target: 851
• Locations: 19 countries
• Sites: 174

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. 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. 2.Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS).

Conditions

Carcinoma, Squamous Cell, Non-small-cell Lung

Keywords

PD-1; PD L1; PD L2

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to approximately 39 months

• 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.

  Up to approximately 46 months

Secondary Outcomes (12)

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

  Up to approximately 4 years

• Number of Participants Who Discontinued Study Intervention Due to an AE

  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

  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

  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

  Baseline and Week 24

Study Arms (2)

Pembrolizumab + Carboplatin + Taxane + Olaparib

EXPERIMENTAL

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; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Olaparib

Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo

ACTIVE COMPARATOR

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; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Placebo

Interventions

Nab-paclitaxel DRUG

IV infusion

Also known as: ABRAXANE®

Pembrolizumab + Carboplatin + Taxane + Olaparib; Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo

Olaparib DRUG

Tablets

Also known as: LYNPARZA®

Pembrolizumab + Carboplatin + Taxane + Olaparib

Placebo DRUG

Placebo to olaparib, tablets

Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475

Pembrolizumab + Carboplatin + Taxane + Olaparib; Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo

Carboplatin DRUG

IV infusion

Also known as: PARAPLATIN®

Pembrolizumab + Carboplatin + Taxane + Olaparib; Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo

Paclitaxel DRUG

IV infusion

Also known as: TAXOL®, ONXAL™

Pembrolizumab + Carboplatin + Taxane + Olaparib; Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
• Have Stage IV squamous NSCLC.
• Have measurable disease based on RECIST 1.1.
• Have not received prior systemic treatment for their advanced/metastatic NSCLC.
• Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
• Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention
• Have a life expectancy of at least 3 months.
• Has adequate organ function.
• Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
• Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (178)

Alabama Oncology Bruno Cancer Center ( Site 0001)

Birmingham, Alabama, 35205, United States

Location

Disney Family Cancer Center ( Site 0005)

Burbank, California, 91505, United States

Location

Boca Raton Regional Hospital ( Site 0018)

Boca Raton, Florida, 33486, United States

Location

Mid-Florida Cancer Centers ( Site 0022)

Orange City, Florida, 32763, United States

Location

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

Tampa, Florida, 33612, United States

Location

Columbus Regional Research Institute ( Site 0099)

Columbus, Georgia, 31904, United States

Location

Mount Sinai Hospital Medical Center ( Site 0035)

Chicago, Illinois, 60608, United States

Location

Oncology of Northshore ( Site 0036)

Rolling Meadows, Illinois, 60008, United States

Location

Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039)

Merrillville, Indiana, 46410, United States

Location

MedStar Franklin Square Medical Center ( Site 0044)

Baltimore, Maryland, 21237, United States

Location

Barbara Ann Karmanos Cancer Institute ( Site 0046)

Detroit, Michigan, 48201, United States

Location

Hattiesburg Clinic ( Site 0051)

Hattiesburg, Mississippi, 39401, United States

Location

Frontier Oncology ( Site 0052)

Billings, Montana, 59102, United States

Location

Bozeman Health Deaconness Cancer Center ( Site 0053)

Bozeman, Montana, 59715, United States

Location

Waverly Hematology Oncology ( Site 0054)

Cary, North Carolina, 27518, United States

Location

Thompson Cancer Survival Center ( Site 2812)

Knoxville, Tennessee, 37804, United States

Location

Renovatio Clinical ( Site 0074)

The Woodlands, Texas, 77380, United States

Location

Cancer Care Northwest ( Site 0083)

Spokane Valley, Washington, 99216, United States

Location

Hospital Italiano Regional del Sur ( Site 0509)

Bahía Blanca, Buenos Aires, B8001HXM, Argentina

Location

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

Location

Hospital Britanico de Buenos Aires ( Site 0500)

Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina

Location

Instituto Medico Rio Cuarto ( Site 0501)

Río Cuarto, Córdoba Province, X5800AEV, Argentina

Location

Sanatorio Parque ( Site 0515)

Rosario, Santa Fe Province, S2000DSV, Argentina

Location

Centro Oncológico de Rosario ( Site 0507)

Rosario, Santa Fe Province, S2000KZE, Argentina

Location

Centro Medico San Roque ( Site 0506)

San Miguel de Tucumán, Tucumán Province, T4000IAK, Argentina

Location

Hospital Italiano de Buenos Aires ( Site 0511)

Buenos Aires, C1199ABB, Argentina

Location

Clínica Universitaria Reina Fabiola ( Site 0505)

Córdoba, X5004FHP, Argentina

Location

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

Santa Fe, S3000AOL, Argentina

Location

Liverpool Hospital ( Site 1201)

Liverpool, New South Wales, 2170, Australia

Location

Southern Medical Day Care Centre ( Site 1200)

Wollongong, New South Wales, 2500, Australia

Location

Townsville General Hospital ( Site 1202)

Townsville, Queensland, 4814, Australia

Location

Monash Cancer Centre ( Site 1205)

Clayton, Victoria, 3168, Australia

Location

Innsbruck LKH ( Site 1302)

Innsbruck, Tyrol, 6020, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)

Linz, Upper Austria, 4020, Austria

Location

Klinikum Wels-Grieskirchen ( Site 1304)

Wels, Upper Austria, 4600, Austria

Location

Social Medical Center - Otto Wagner Hospital ( Site 1301)

Vienna, Vienna, 1145, Austria

Location

Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)

Vienna, 1210, Austria

Location

Instituto do Cancer do Ceara ( Site 0251)

Fortaleza, Ceará, 60430-230, Brazil

Location

Hospital Sao Rafael ( Site 0258)

Salvador - BA, Estado de Bahia, 41253-190, Brazil

Location

Oncologica do Brasil ( Site 0256)

Belém, Pará, 66053-000, Brazil

Location

Hospital Tacchini ( Site 0265)

Bento Gonçalves, Rio Grande do Sul, 95700-000, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

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

Itajaí, Santa Catarina, 88301-220, Brazil

Location

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

Sao Jose Rio Preto, São Paulo, 15090-000, Brazil

Location

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

Rio de Janeiro, 20230-130, Brazil

Location

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

São Paulo, 01246-000, Brazil

Location

Hospital Paulistano - Amil Clinical Research ( Site 0263)

São Paulo, 01321-001, Brazil

Location

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0260)

São Paulo, 01321-001, Brazil

Location

Nova Scotia Health Authority ( Site 0103)

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0107)

Hamilton, Ontario, L8V5C2, Canada

Location

Kingston Health Sciences Centre ( Site 0102)

Kingston, Ontario, K7L 2V7, Canada

Location

Stronach Regional Cancer Centre ( Site 0100)

Newmarket, Ontario, L3Y 2P9, Canada

Location

CISSS de la Monteregie-Centre ( Site 0101)

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Hopital Cite de la Sante de Laval ( Site 0105)

Laval, Quebec, H7M 3L9, Canada

Location

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

Montreal, Quebec, H3T 1M5, Canada

Location

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

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Centre Hospitalier De Chauny ( Site 1411)

Chauny, Aisne, 02300, France

Location

CHU Caen ( Site 1406)

Caen, Calvados, 14033, France

Location

CHU Angers ( Site 1405)

Angers, Maine-et-Loire, 49100, France

Location

Institut De Cancerologie De Lorraine ( Site 1409)

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

Location

Hopital Robert Schuman ( Site 1402)

Vantoux, Moselle, 57070, France

Location

Centre Jean Perrin ( Site 1407)

Clermont-Ferrand, Puy-de-Dome, 63011, France

Location

Centre Hospitalier de Pau ( Site 1412)

Pau, Pyrenees-Atlantiques, 64000, France

Location

CHU de Rouen ( Site 1403)

Rouen, Seine-Maritime, 76000, France

Location

Hopital d'Instruction des Armees Begin ( Site 1413)

Saint-Mandé, Val-de-Marne, 94163, France

Location

Studienzentrum Aschaffenburg ( Site 1575)

Aschaffenburg, Bavaria, 63739, Germany

Location

Klinikum der LMU ( Site 1550)

Munich, Bavaria, 80336, Germany

Location

Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1573)

Munich, Bavaria, 81925, Germany

Location

Universitaetsklinikum Regensburg ( Site 1562)

Regensburg, Bavaria, 93042, Germany

Location

Klinikum Wuerzburg Mitte gGmbH ( Site 1559)

Würzburg, Bavaria, 97074, Germany

Location

Universitaetsklinikum Frankfurt ( Site 1563)

Frankfurt am Main, Hesse, 60590, Germany

Location

Pneumologische Lehrklinik Universitaet Goettingen ( Site 1551)

Immenhausen, Hesse, 34376, Germany

Location

Universitaetsmedizin Goettingen ( Site 1557)

Göttingen, Lower Saxony, 37075, Germany

Location

Universitaetsklinikum Bonn ( Site 1574)

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Kliniken Essen Mitte ( Site 1567)

Essen, North Rhine-Westphalia, 45136, Germany

Location

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

Koblenz, Rhineland-Palatinate, 56068, Germany

Location

Helios Klinikum Erfurt GmbH ( Site 1552)

Erfurt, Thuringia, 99089, Germany

Location

Katholisches Marienkrankenhaus gGmbH ( Site 1572)

Hamburg, 22087, Germany

Location

National Hospital Organization Nagoya Medical Center ( Site 0806)

Nagoya, Aichi-ken, 460-0001, Japan

Location

Aichi Cancer Center Hospital ( Site 0803)

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East ( Site 0801)

Kashiwa, Chiba, 277-8577, Japan

Location

Kurume University Hospital ( Site 0814)

Kurume, Fukuoka, 830-0011, Japan

Location

Kanazawa University Hospital ( Site 0811)

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Kanagawa Cancer Center ( Site 0807)

Yokohama, Kanagawa, 241-8515, Japan

Location

Sendai Kousei Hospital ( Site 0812)

Sendai, Miyagi, 980-0873, Japan

Location

Kansai Medical University Hospital ( Site 0804)

Hirakata, Osaka, 573-1191, Japan

Location

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

Sakai, Osaka, 591-8555, Japan

Location

Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)

Sunto-gun, Shizuoka, 411-8777, Japan

Location

National Hospital Organization Kyushu Medical Center ( Site 0805)

Fukuoka, 810-8563, Japan

Location

Niigata Cancer Center Hospital ( Site 0808)

Niigata, 951-8566, Japan

Location

Okayama University Hospital ( Site 0810)

Okayama, 700-8558, Japan

Location

Osaka International Cancer Institute ( Site 0809)

Osaka, 541-8567, Japan

Location

The Cancer Institute Hospital of JFCR ( Site 0800)

Tokyo, 135-8550, Japan

Location

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

La Paz, Baja California Sur, 23040, Mexico

Location

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0334)

Guadalajara, Jalisco, 44280, Mexico

Location

Arke Estudios Clinicos ( Site 0333)

Mexico City, Mexico City, 06700, Mexico

Location

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

Monterrey, Nuevo León, 64060, Mexico

Location

CLIMERS Clinical Medical Research ( Site 0306)

Orizaba, Veracruz, 94300, Mexico

Location

FAICIC Clinical Research ( Site 0303)

Veracruz, 91900, Mexico

Location

MidCentral DHB Palmerston North Hospital ( Site 1102)

Palmerston North, Manawatu-Wanganui, 4414, New Zealand

Location

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

Wellington, 6021, New Zealand

Location

Przychodnia Lekarska Komed ( Site 2416)

Konin, Greater Poland Voivodeship, 62-500, Poland

Location

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

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)

Krakow, Lesser Poland Voivodeship, 31-202, Poland

Location

Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)

Olsztyn, Lower Silesian Voivodeship, 10-357, Poland

Location

Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)

Zgorzelec, Lower Silesian Voivodeship, 59-900, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)

Racibórz, Silesian Voivodeship, 47-400, Poland

Location

Cardiomed SRL Cluj-Napoca ( Site 2504)

Cluj-Napoca, Cluj, 400015, Romania

Location

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

Cluj-Napoca, Cluj, 407280, Romania

Location

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

Craiova, Dolj, 200347, Romania

Location

Policlinica Oncomed SRL ( Site 2505)

Timișoara, Timiș County, 300239, Romania

Location

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

Bucharest, 022548, Romania

Location

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

Constanța, 900591, Romania

Location

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

Moscow, Moscow, 115478, Russia

Location

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

Moscow, Moscow, 119991, Russia

Location

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

Moscow, Moscow, 125284, Russia

Location

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

Moscow, Moscow, 125367, Russia

Location

Moscow Regional Oncological Dispensary ( Site 2028)

Balashikha, Moscow Oblast, 143900, Russia

Location

Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)

Nizhny Novgorod, Nizhny Novgorod Oblast, 603081, Russia

Location

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

Omsk, Omsk Oblast, 644013, Russia

Location

SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)

Samara, Samara Oblast, 443031, Russia

Location

SBHI Leningrad Regional Clinical Hospital ( Site 2002)

Saint Petersburg, Sankt-Peterburg, 194291, Russia

Location

SPb Central Clinical Railway Hospital ( Site 2003)

Saint Petersburg, Sankt-Peterburg, 195271, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

SPb SBHI City Clinical Oncological Dispensary ( Site 2001)

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021)

Kazan', Tatarstan, Respublika, 420029, Russia

Location

National Cancer Center ( Site 1006)

Goyang-si, Kyonggi-do, 10408, South Korea

Location

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

Gyeonggi-do, Kyonggi-do, 16247, South Korea

Location

Ajou University Hospital ( Site 1004)

Suwon, Kyonggi-do, 16499, South Korea

Location

Gyeongsang National University Hospital ( Site 1005)

Jinju, Kyongsangnam-do, 52727, South Korea

Location

Chungbuk National University Hospital ( Site 1002)

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Asan Medical Center ( Site 1007)

Songpa-gu, Seoul, 05505, South Korea

Location

Seoul National University Hospital ( Site 1000)

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 1001)

Seoul, 03722, South Korea

Location

Korea University Guro Hospital ( Site 1008)

Seoul, 08308, South Korea

Location

Hospital Duran i Reynals ( Site 1710)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Complejo Hospitalario de Jaen ( Site 1713)

Jaén, La Coruna, 23007, Spain

Location

Hospital Sant Creu i Sant Pau ( Site 1711)

Barcelona, 08041, Spain

Location

Hospital Universitario 12 de Octubre ( Site 1716)

Madrid, 28041, Spain

Location

Complejo Hospitalario de Malaga ( Site 1714)

Málaga, 29010, Spain

Location

Hospital Universitario Virgen Macarena ( Site 1712)

Seville, 41009, Spain

Location

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)

Kaohsiung City, 83301, Taiwan

Location

China Medical University Hospital ( Site 0904)

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital ( Site 0905)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 0900)

Taipei, 10048, Taiwan

Location

Mackay Memorial Hospital ( Site 0902)

Taipei, 104, Taiwan

Location

Chang Gung Medical Foundation.Linkou Branch ( Site 0903)

Taoyuan District, 333, Taiwan

Location

Namik Kemal Universitesi Tip Fakultesi ( Site 2100)

Tekirdağ, Tekirdas, 59100, Turkey (Türkiye)

Location

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

Adana, 01120, Turkey (Türkiye)

Location

Gazi Universitesi Tip Fakultesi ( Site 2104)

Ankara, 06500, Turkey (Türkiye)

Location

Ankara Sehir Hastanesi ( Site 2105)

Ankara, 06800, Turkey (Türkiye)

Location

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

Istanbul, 34093, Turkey (Türkiye)

Location

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

Istanbul, 34722, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi ( Site 2109)

Izmir, 35040, Turkey (Türkiye)

Location

Erciyes Universitesi Tip Fakultesi ( Site 2108)

Kayseri, 38039, Turkey (Türkiye)

Location

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

Samsun, 55270, Turkey (Türkiye)

Location

Cherkasy Regional Oncology Dispensary ( Site 2225)

Cherkasy, Cherkasy Oblast, 18009, Ukraine

Location

City Clinical Hosp.4 of DCC ( Site 2215)

Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine

Location

MI Precarpathian Clinical Oncology Center ( Site 2218)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

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

Kharkiv, Kharkivs’ka Oblast’, 61024, Ukraine

Location

Regional Centre of Oncology-Thoracic organs ( Site 2219)

Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine

Location

PP PPC Acinus Medical and Diagnostic Centre ( Site 2223)

Kropyvnytskyi, Kirovohrad Oblast, 25006, Ukraine

Location

Medical Center Asklepion LLC ( Site 2243)

Khodosovka, Kyivska Oblast, 08173, Ukraine

Location

Kyiv City Clinical Oncology Centre ( Site 2224)

Kyiv, Kyivska Oblast, 03115, Ukraine

Location

Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2227)

Kyiv, Kyivska Oblast, 03126, Ukraine

Location

MI Odessa Regional Oncological Centre ( Site 2222)

Odesa, Odesa Oblast, 65055, Ukraine

Location

Central City Clinical Hospital ( Site 2221)

Uzhhorod, Zakarpattia Oblast, 88000, Ukraine

Location

Medical Center Verum ( Site 2228)

Kyiv, 03039, Ukraine

Location

Southend University Hospital NHS Foundation Trust ( Site 1913)

Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom

Location

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

London, London, City of, EC1M 6BQ, United Kingdom

Location

Chelsea and Westminster Hospital ( Site 1901)

London, London, City of, SW10 9NH, United Kingdom

Location

Newcastle Freeman Hospital ( Site 1902)

Newcastle upon Tyne, Newcastle Upon Tyne, NE7 7DN, United Kingdom

Location

West Suffolk Hospitals NHS Trust ( Site 1919)

Bury St Edmunds, Suffolk, IP33 2QZ, United Kingdom

Location

Western General Hospital, Edinburgh ( Site 1924)

Edinburgh, United Kingdom, EH4 2XU, United Kingdom

Location

Singleton Hospital ( Site 1909)

Swansea, Wales, SA2 8QA, United Kingdom

Location

Colchester General Hospital ( Site 1911)

Colchester, Worcestershire, CO4 5JL, United Kingdom

Location

Birmingham Heartlands Hospital ( Site 1910)

Birmingham, B9 5SS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39477187 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma

Interventions

pembrolizumab; Carboplatin; Paclitaxel; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; olaparib

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 6, 2019
• Study Start: June 28, 2019
• Primary Completion: September 21, 2023
• Study Completion: January 30, 2026
• Last Updated: February 25, 2026
• Results First Posted: November 6, 2024

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

UA (12); CA (8); AU (5); TU (9); NZ (2); KR (9); RO (6); ME (6); TW (6); GB (9); AR (10); DE (13); US (18); PL (7); JP (15); BR (11); RU (13); FR (9); ES (6)