A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)

NCT06312137 | Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: 2870-0192023-508012-35-00MK-2870-019jRCT2021240020U1111-1297-4260
• Study Type: interventional
• Target: 780
• Locations: 30 countries
• Sites: 261

Brief Summary

This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).

Conditions

Non Small Cell Lung Cancer

Keywords

Carcinoma; Lung cancer; Non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)

  DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.

  Up to ~ 93 months

Secondary Outcomes (12)

• Overall Survival (OS)

  Up to ~ 118 months

• Distant metastasis-free survival (DMFS) as assessed by investigator

  Up to ~ 118 months

• Disease-Free Survival (DFS) as assessed by investigator

  Up to ~ 118 months

• Lung Cancer Specific Survival (LCSS)

  Up to ~ 118 months

• Number of Participants Who Experience an Adverse Event (AE)

  Up to ~ 118 months

Study Arms (2)

Pembrolizumab + Sacituzumab tirumotecan

EXPERIMENTAL

Participants will receive pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by sacituzumab tirumotecan 4 mg/kg IV infusion every 2 weeks (Q2W) for up to 12 doses (\~24 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (\~42 weeks).

Biological: Sacituzumab tirumotecan; Biological: Pembrolizumab; Drug: Rescue medication

Pembrolizumab

ACTIVE COMPARATOR

Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (\~42 weeks).

Biological: Pembrolizumab; Drug: Cisplatin; Drug: Pemetrexed; Drug: Gemcitabine; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Carboplatin DRUG

Carboplatin will be administered in the neoadjuvant phase as AUC 5 mg/mL/min or AUC 6 mg/mL/min IV infusion q3w for up to 12 weeks as background treatment.

Pembrolizumab

Pembrolizumab BIOLOGICAL

Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks

Also known as: MK-3475

Pembrolizumab; Pembrolizumab + Sacituzumab tirumotecan

Cisplatin DRUG

Cisplatin is administered as 75 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase

Pembrolizumab

Pemetrexed DRUG

Pemetrexed will be administered in the neoadjuvant phase as 500 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in participants with nonsquamous NSCLC.

Pembrolizumab

Paclitaxel DRUG

Paclitaxel will be administered in the neoadjuvant phase as 175 mg/m2 or 200 mg/m2 IV infusion q3w for up to 12 weeks as background treatment.

Pembrolizumab

Sacituzumab tirumotecan BIOLOGICAL

Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks

Also known as: MK-2870, sac-TMT, SKB264

Pembrolizumab + Sacituzumab tirumotecan

Gemcitabine DRUG

Gemcitabine will be administered in the neoadjuvant phase as 1000 mg/m2 or 1250 mg/m2 IV infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in participants with squamous NSCLC.

Pembrolizumab

Rescue medication DRUG

Participants are allowed to take rescue medication to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.

Pembrolizumab + Sacituzumab tirumotecan

Eligibility Criteria

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

You may not qualify if:

• Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement \[N2\]) per AJCC eighth edition guidelines
• Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy
• Is able to undergo surgery based on opinion of investigator after consultation with surgeon
• Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy
• Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology.
• Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period
• Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization
• Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load at screening
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention
• Has one of the following tumor locations/types:
• NSCLC involving the superior sulcus
• Large cell neuro-endocrine cancer (LCNEC)
• Sarcomatoid tumor

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (264)

UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060)

Little Rock, Arkansas, 72205, United States

RECRUITING

Highlands Oncology Group-Research Department ( Site 0062)

Springdale, Arkansas, 72762, United States

RECRUITING

Beverly Hills Cancer Center ( Site 0070)

Beverly Hills, California, 90211, United States

RECRUITING

The Angeles Clinic and Research Institute ( Site 0040)

Los Angeles, California, 90025, United States

RECRUITING

The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079)

Los Angeles, California, 90025, United States

RECRUITING

UCLA Clinical & Translational Research Center (CTRC) ( Site 0033)

Los Angeles, California, 90095, United States

RECRUITING

Hoag Memorial Hospital Presbyterian ( Site 0096)

Newport Beach, California, 92663, United States

RECRUITING

St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 4002)

Orange, California, 92868, United States

RECRUITING

San Francisco Oncology Associates ( Site 0066)

San Francisco, California, 94115, United States

RECRUITING

Stamford Hospital ( Site 0083)

Stamford, Connecticut, 06902, United States

RECRUITING

Mayo Clinic in Florida ( Site 0014)

Jacksonville, Florida, 32224, United States

RECRUITING

Mount Sinai Cancer Center ( Site 0038)

Miami Beach, Florida, 33140, United States

RECRUITING

Mid Florida Hematology and Oncology Center ( Site 0018)

Orange City, Florida, 32763, United States

RECRUITING

Emory University School of Medicine-Phase I ( Site 0056)

Atlanta, Georgia, 30322, United States

RECRUITING

Northside Hospital ( Site 0055)

Atlanta, Georgia, 30342, United States

RECRUITING

Centricity Research Columbus Cancer Center ( Site 0005)

Columbus, Georgia, 31904, United States

COMPLETED

Southeastern Regional Medical Center ( Site 0065)

Newnan, Georgia, 30265, United States

RECRUITING

Lewis Cancer and Research Pavilion ( Site 0063)

Savannah, Georgia, 31405, United States

RECRUITING

Archbold Cancer Center ( Site 0071)

Thomasville, Georgia, 31792, United States

RECRUITING

Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0017)

Elmhurst, Illinois, 60126, United States

COMPLETED

Accellacare of Duly ( Site 4005)

Lisle, Illinois, 60532, United States

RECRUITING

Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0078)

Naperville, Illinois, 60540, United States

COMPLETED

Parkview Research Center at Parkview Regional Medical Center ( Site 0089)

Fort Wayne, Indiana, 46845, United States

RECRUITING

Indiana University Health Arnett Cancer Center ( Site 0076)

Lafayette, Indiana, 47904, United States

RECRUITING

Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0061)

Edgewood, Kentucky, 41017, United States

RECRUITING

LSU Health Baton Rouge North Clinic ( Site 4003)

Baton Rouge, Louisiana, 70805, United States

RECRUITING

Our Lady of the Lake Physician Group-Medical Oncology ( Site 0080)

Baton Rouge, Louisiana, 70808, United States

RECRUITING

New England Cancer Specialists ( Site 0095)

Westbrook, Maine, 04092, United States

RECRUITING

Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027)

Minneapolis, Minnesota, 55407, United States

RECRUITING

Mayo Clinic - Rochester ( Site 0073)

Rochester, Minnesota, 55905, United States

RECRUITING

Mercy South - David M Sindelar Cancer Center ( Site 0098)

St Louis, Missouri, 63128, United States

RECRUITING

Mercy Research - David C. Pratt Cancer Center ( Site 0006)

St Louis, Missouri, 63141, United States

RECRUITING

Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037)

Reno, Nevada, 89502, United States

RECRUITING

Atlantic Health Morristown Medical Center ( Site 0077)

Morristown, New Jersey, 07960, United States

RECRUITING

Cayuga Medical Center ( Site 0086)

Ithaca, New York, 14850, United States

RECRUITING

Stony Brook University-Cancer Center ( Site 0054)

Stony Brook, New York, 11794, United States

RECRUITING

White Plains Hospital ( Site 0091)

White Plains, New York, 10601, United States

RECRUITING

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0057)

Fargo, North Dakota, 58102, United States

RECRUITING

Hightower Clinical, LLC ( Site 0084)

Oklahoma City, Oklahoma, 73102, United States

RECRUITING

Oregon Health and Science University ( Site 0052)

Portland, Oregon, 97239, United States

RECRUITING

Penn State Milton S. Hershey Medical Center-Penn State Cancer Institute ( Site 0059)

Hershey, Pennsylvania, 17033, United States

RECRUITING

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0068)

Lancaster, Pennsylvania, 17601, United States

RECRUITING

Saint Joseph's Candler Health System ( Site 4010)

Bluffton, South Carolina, 29910, United States

RECRUITING

Medical University of South Carolina-Hollings Cancer Center ( Site 0045)

Charleston, South Carolina, 29425, United States

RECRUITING

Sanford Cancer Center ( Site 0053)

Sioux Falls, South Dakota, 57104, United States

RECRUITING

Avera Cancer Institute- Research ( Site 0090)

Sioux Falls, South Dakota, 57105, United States

RECRUITING

University of Tennessee Medical Center Knoxville ( Site 0082)

Knoxville, Tennessee, 37920, United States

RECRUITING

Millennium Research & Clinical Development ( Site 0039)

Houston, Texas, 77090, United States

COMPLETED

Huntsman Cancer Institute ( Site 0042)

Salt Lake City, Utah, 84112-5500, United States

RECRUITING

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0213)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

RECRUITING

Hospital Británico de Buenos Aires-Oncology ( Site 0207)

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina

RECRUITING

Sanatorio Británico-Clinical Oncology Department ( Site 0206)

Rosario, Santa Fe Province, S2000CVB, Argentina

RECRUITING

Sanatorio Parque ( Site 0205)

Rosario, Santa Fe Province, S2000DSV, Argentina

RECRUITING

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 0217)

San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina

RECRUITING

Hospital Aleman-Oncology ( Site 0202)

Buenos Aires, C1118AAT, Argentina

RECRUITING

Hospital Privado Universitario de Córdoba-Hematology and Oncology ( Site 0204)

Córdoba, X5016KEH, Argentina

RECRUITING

Westmead Hospital ( Site 0701)

Westmead, New South Wales, 2145, Australia

RECRUITING

The Prince Charles Hospital ( Site 0700)

Brisbane, Queensland, 4032, Australia

RECRUITING

Fiona Stanley Hospital-Medical Oncology ( Site 0705)

Murdoch, Western Australia, 6150, Australia

RECRUITING

Medizinische Universitaet Innsbruck-Department for Internal Medicine V ( Site 1403)

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 1402)

Linz, Upper Austria, 4020, Austria

RECRUITING

Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 1401)

Vienna, 1140, Austria

RECRUITING

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1400)

Vienna, 1210, Austria

RECRUITING

Antwerp University Hospital-Thoracic Oncology ( Site 1503)

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi ( Site 1502)

Yvoir, Namur, 5530, Belgium

RECRUITING

VITAZ ( Site 1500)

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

RECRUITING

Liga Norte Riograndense Contra o Câncer ( Site 0301)

Natal, Rio Grande do Norte, 59062-000, Brazil

RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0303)

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

RECRUITING

Hospital Nossa Senhora da Conceição ( Site 0302)

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

RECRUITING

Instituto de Oncologia Saint Gallen ( Site 0319)

Santa Cruz do Sul, Rio Grande do Sul, 96830-180, Brazil

RECRUITING

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0304)

Barretos, São Paulo, 14784400, Brazil

RECRUITING

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0313)

São José do Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 0305)

São Paulo, 01246-000, Brazil

RECRUITING

Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0100)

Greenfield Park, Quebec, J4V 2H1, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal ( Site 0104)

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

St. Marys Hospital Center ( Site 0107)

Montreal, Quebec, H3T 1M5, Canada

RECRUITING

McGill University Health Centre ( Site 0105)

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

FALP-UIDO ( Site 0401)

Providencia, Region M. de Santiago, 7500921, Chile

RECRUITING

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0404)

Santiago, Region M. de Santiago, 7500653, Chile

RECRUITING

Clínica RedSalud Vitacura ( Site 0412)

Santiago, Region M. de Santiago, 7650018, Chile

RECRUITING

Bradfordhill-Clinical Area ( Site 0400)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

ONCOCENTRO APYS-ACEREY ( Site 0410)

Viña del Mar, Valparaiso, 2520598, Chile

RECRUITING

Beijing Cancer hospital-Thoracic Surgery department I ( Site 1301)

Beijing, Beijing Municipality, 100010, China

RECRUITING

Beijing Peking Union Medical College Hospital-Thoracic surgery department ( Site 1302)

Beijing, Beijing Municipality, 100730, China

RECRUITING

Peking University People's Hospital ( Site 1300)

Beijing, Beijing Municipality, 101109, China

RECRUITING

Fujian Cancer Hospital-oncology department ( Site 1314)

Fuzhou, Fujian, 350014, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University-thoracic surgery department ( Site 1320)

Guangzhou, Guangdong, 510120, China

RECRUITING

Southern Medical University Nanfang Hospital-Thoracic surgery department ( Site 1313)

Guangzhou, Guangdong, 510515, China

RECRUITING

Henan Cancer Hospital-henan cancer hospital ( Site 1316)

Zhengzhou, Henan, 450000, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology-Thoracic Surgery ( Site 1306)

Wuhan, Hubei, 430022, China

RECRUITING

Hubei Cancer Hospital ( Site 1308)

Wuhan, Hubei, 430079, China

RECRUITING

Xiangya Hospital Central South University-Thoracic surgery ( Site 1311)

Changsha, Hunan, 410008, China

RECRUITING

Hunan Cancer Hospital ( Site 1312)

Changsha, Hunan, 410013, China

RECRUITING

Nanjing First Hospital ( Site 1310)

Nanjing, Jiangsu, 210012, China

RECRUITING

The First Affiliated Hospital of Soochow University-Thoracic Surgery Department ( Site 1318)

Suzhou, Jiangsu, 215006, China

RECRUITING

The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 1330)

Nanchang, Jiangxi, 330209, China

RECRUITING

The First Hospital of Jilin University ( Site 1324)

Changchun, Jilin, 130031, China

RECRUITING

The Second Affiliated Hospital of Air Force Medical University ( Site 1332)

Xi'an, Shaanxi, 710038, China

RECRUITING

Shandong Cancer Hospital ( Site 1321)

Jinan, Shandong, 250117, China

RECRUITING

Zhongshan Hospital Fudan University ( Site 1325)

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 1304)

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Sichuan Cancer hospital. ( Site 1327)

Chengdu, Sichuan, 610042, China

RECRUITING

The Second People's Hospital of Neijiang ( Site 1322)

Neijiang, Sichuan, 641000, China

COMPLETED

Yunnan Province Cancer Hospital ( Site 1315)

Kunming, Yunnan, 650107, China

RECRUITING

The first Affiliated Hospital, Zhejiang University School of-Thoracic Cardiovascular Surgery Ward ( Site 1303)

Hangzhou, Zhejiang, 310003, China

RECRUITING

Zhejiang Cancer Hospital ( Site 1309)

Hangzhou, Zhejiang, 310022, China

RECRUITING

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 1328)

Hangzhou, Zhejiang, 31009, China

RECRUITING

Taizhou Hospital of Zhejiang Province ( Site 1329)

Linhai, Zhejiang, 317000, China

RECRUITING

Ningbo No. 2 Hospital ( Site 1305)

Ningbo, Zhejiang, 315010, China

RECRUITING

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1600)

Brno, Brno-mesto, 656 53, Czechia

RECRUITING

Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 1601)

Ostrava, Ostrava Mesto, 703 00, Czechia

RECRUITING

CHRU de Brest ( Site 1804)

Brest, Finistere, 29609, France

RECRUITING

CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1801)

Toulouse, Haute-Garonne, 31400, France

RECRUITING

CHU Charles Nicolle ( Site 1803)

Rouen, Haute-Normandie, 76000, France

RECRUITING

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1805)

Limoges, Haute-Vienne, 87042, France

RECRUITING

Clinique Teissier Groupe ( Site 1811)

Valenciennes, Nord, 59304, France

RECRUITING

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1810)

Clermont-Ferrand, Puy-de-Dome, 63003, France

RECRUITING

Hospices Civils de Lyon - Hopital Louis Pradel ( Site 1809)

Bron, Rhone, 69677, France

RECRUITING

HIA Sainte Anne ( Site 1800)

Toulon, Var, 83800 Cede, France

RECRUITING

Hôpital Tenon ( Site 1802)

Paris, 75020, France

RECRUITING

Groupe hospitalier Paris saint Joseph. ( Site 1807)

Paris, Île-de-France Region, 75014, France

RECRUITING

Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1914)

Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

RECRUITING

Universitaetsklinikum Regensburg ( Site 1907)

Regensburg, Bavaria, 93053, Germany

RECRUITING

Lungenklinik Hemer ( Site 1905)

Hemer, North Rhine-Westphalia, 58675, Germany

RECRUITING

Katholisches Klinikum Koblenz ( Site 1911)

Koblenz, Rhineland-Palatinate, 56073, Germany

RECRUITING

Universitätsklinikum Leipzig ( Site 1915)

Leipzig, Saxony, 04103, Germany

RECRUITING

Krankenhaus Martha-Maria Halle-Dölau-Klinik für Innere Medizin II ( Site 1908)

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

Zentralklinik Bad Berka-Klinik für Hämatologie und Onkologie ( Site 1902)

Bad Berka, Thuringia, 99437, Germany

RECRUITING

SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 1900)

Gera, Thuringia, 07548, Germany

RECRUITING

Evangelische Lungenklinik Berlin-Pneumologie ( Site 1904)

Berlin, 13125, Germany

RECRUITING

Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1903)

Berlin, 13353, Germany

RECRUITING

Vivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- ( Site 1912)

Berlin, 13585, Germany

RECRUITING

Helios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1916)

Berlin, 14165, Germany

RECRUITING

UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 2006)

Pátrai, Achaia, 26504, Greece

RECRUITING

251 Hellenic Air Force General Hospital ( Site 2003)

Athens, Attica, 115 25, Greece

RECRUITING

THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 2000)

Athens, Attica, 115 27, Greece

RECRUITING

Athens Medical Center ( Site 2005)

Athens, Attica, 151 25, Greece

RECRUITING

Metaxa Cancer Hospital of Piraeus ( Site 2002)

Piraeus, Attica, 185 37, Greece

RECRUITING

University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2001)

Heraklion, Irakleio, 715 00, Greece

RECRUITING

University General Hospital of Larissa-Oncology Clinic ( Site 2004)

Larissa, Thessaly, 411 10, Greece

RECRUITING

European Interbalkan Medical Center ( Site 2007)

Thessaloniki, 57001, Greece

RECRUITING

Queen Mary Hospital ( Site 3400)

Hksar, Hong Kong

RECRUITING

Hong Kong United Oncology Centre ( Site 3403)

Kowloon, Hong Kong

RECRUITING

Queen Elizabeth Hospital ( Site 3402)

Yau Ma Tei, 999077, Hong Kong

RECRUITING

Rambam Health Care Campus-Oncology Division ( Site 2203)

Haifa, 3109601, Israel

RECRUITING

Shaare Zedek Medical Center ( Site 2206)

Jerusalem, 9103102, Israel

RECRUITING

Rabin Medical Center ( Site 2204)

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center ( Site 2200)

Ramat Gan, 5265601, Israel

RECRUITING

Humanitas Istituto Clinico Catanese ( Site 2315)

Misterbianco, Catania, 95045, Italy

RECRUITING

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 2302)

Meldola, Emilia-Romagna, 47014, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 2300)

Milan, Lombardy, 20133, Italy

RECRUITING

San Paolo - ASST SANTI PAOLO E CARLO ( Site 2314)

Milan, Lombardy, 20142, Italy

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 2301)

Monza, Lombardy, 20900, Italy

RECRUITING

Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 2309)

Rome, Roma, 00144, Italy

RECRUITING

Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 2307)

Florence, Tuscany, 50134, Italy

RECRUITING

Humanitas Gavazzeni-ONCOLOGY ( Site 2310)

Bergamo, 24125, Italy

RECRUITING

Ospedale San Martino ( Site 2313)

Genova, 16132, Italy

RECRUITING

Ospedale San Raffaele-Oncologia Medica ( Site 2311)

Milan, 20132, Italy

RECRUITING

Azienda Ospedaliero Universitaria di Parma ( Site 2312)

Parma, 43126, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 2303)

Pavia, 27100, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 2306)

Roma, 00168, Italy

RECRUITING

APSS- Presidio Ospedaliero S. Chiara ( Site 2304)

Trento, 38122, Italy

RECRUITING

National Cancer Center Hospital East ( Site 1202)

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

National Hospital Organization Shikoku Cancer Center ( Site 1216)

Matsuyama, Ehime, 791-0280, Japan

RECRUITING

Hospital of the University of Occupational and Environmental Health, Japan ( Site 1217)

Kitakyushu, Fukuoka, 807-8556, Japan

RECRUITING

Kobe City Medical Center General Hospital ( Site 1213)

Kobe, Hyōgo, 650-0047, Japan

RECRUITING

St. Marianna University Hospital ( Site 1207)

Kawasaki, Kanagawa, 216-8511, Japan

RECRUITING

Kanagawa Cancer Center ( Site 1206)

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Kansai Medical University Hospital ( Site 1211)

Hirakata, Osaka, 573-1191, Japan

RECRUITING

Kindai University Hospital ( Site 1212)

Sakai, Osaka, 590-0197, Japan

RECRUITING

Saitama Prefectural Cancer Center ( Site 1201)

Kitaadachi-gun, Saitama, 3620806, Japan

RECRUITING

Juntendo University Hospital ( Site 1204)

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

Tokyo Medical University Hospital ( Site 1203)

Shinjuku, Tokyo, 160-0023, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center ( Site 1218)

Fukuoka, 811-1395, Japan

RECRUITING

Fukushima Medical University Hospital ( Site 1200)

Fukushima, 960-1295, Japan

RECRUITING

Hiroshima University Hospital ( Site 1215)

Hiroshima, 734-8551, Japan

RECRUITING

Nagasaki University Hospital ( Site 1220)

Nagasaki, 852-8501, Japan

RECRUITING

Niigata Cancer Center Hospital ( Site 1208)

Niigata, 951-8566, Japan

RECRUITING

Okayama University Hospital ( Site 1214)

Okayama, 700-8558, Japan

RECRUITING

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1210)

Osaka, 541-8567, Japan

RECRUITING

Nippon Medical School Hospital ( Site 1205)

Tokyo, 113-8603, Japan

RECRUITING

Yamagata University Hospital ( Site 1219)

Yamagata, 990-9585, Japan

RECRUITING

CIO - Centro de Inmuno-Oncología de Occidente ( Site 0506)

Guadalajara, Jalisco, 44630, Mexico

RECRUITING

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0508)

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Centro de Investigacion Clinica de Oaxaca ( Site 0509)

Oaxaca City, Oaxaca, 68020, Mexico

RECRUITING

Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 0504)

Chihuahua City, 31123, Mexico

RECRUITING

Mediadvance Clinical ( Site 0502)

Chihuahua City, 31203, Mexico

RECRUITING

Oaxaca Site Management Organization S.C. ( Site 0507)

Oaxaca City, 68000, Mexico

RECRUITING

Amphia Ziekenhuis, locatie Breda Molengracht-long oncologie ( Site 3453)

Breda, North Brabant, 4818 CK, Netherlands

RECRUITING

Isala, locatie Zwolle-Poli Longziekten ( Site 3454)

Zwolle, Overijssel, 8025 BK, Netherlands

RECRUITING

Leids Universitair Medisch Centrum-Longziekten ( Site 3451)

Leiden, South Holland, 2333 ZG, Netherlands

RECRUITING

Erasmus Medisch Centrum ( Site 3452)

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Meander Medisch Centrum-Researchbureau Longgeneeskunde ( Site 3458)

Amersfoort, Utrecht, 3813TZ, Netherlands

RECRUITING

University Medical Center Groningen ( Site 3459)

Groningen, 9713 GZ, Netherlands

RECRUITING

Martini Ziekenhuis ( Site 3460)

Groningen, 9728 NT, Netherlands

RECRUITING

Sint Antonius Ziekenhuis ( Site 3455)

Utrecht, 3543 AZ, Netherlands

RECRUITING

Auckland City Hospital ( Site 0800)

Auckland, 1023, New Zealand

RECRUITING

Akershus Universitetssykehus ( Site 2501)

Lørenskog, Akershus, 1478, Norway

RECRUITING

Drammen Sykehus, Vestre Viken HF ( Site 2502)

Drammen, Buskerud, 3004, Norway

RECRUITING

Sykehuset Innlandet HF Gjøvik ( Site 2503)

Gjøvik, Oppland, 2819, Norway

RECRUITING

Oslo universitetssykehus HF. Radiumhospitalet ( Site 2504)

Oslo, 0379, Norway

RECRUITING

IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0604)

Lima, 15036, Peru

RECRUITING

Oncosalud ( Site 0602)

Lima, 15036, Peru

RECRUITING

INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 0600)

Lima, 15038, Peru

RECRUITING

Instituto Neuro Cardiovascular de las Americas ( Site 0607)

Lima, 15038, Peru

RECRUITING

Hospital Nacional Edgardo Rebagliati Martins-medical oncology ( Site 0603)

Lima, Lima11, Peru

RECRUITING

Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 2602)

Poznan, Greater Poland Voivodeship, 60-569, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny nr 4 w Lublinie ( Site 2611)

Lublin, Lublin Voivodeship, 20-090, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2600)

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2601)

Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

RECRUITING

Bialostockie Centrum Onkologii ( Site 2604)

Bialystok, Podlaskie Voivodeship, 15-027, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny w Białymstoku ( Site 2612)

Bialystok, Podlaskie Voivodeship, 15-540, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne ( Site 2610)

Gdansk, Pomeranian Voivodeship, 80-214, Poland

ACTIVE NOT RECRUITING

Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 2613)

Prabuty, Pomeranian Voivodeship, 82-550, Poland

RECRUITING

Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii ( Site 2606)

Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland

RECRUITING

Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 2703)

Lisbon, Lisbon District, 1769-001, Portugal

RECRUITING

UNIDADE LOCAL DE SAUDE DE MATOSINHOS-Serviço de Oncologia ( Site 2705)

Matosinhos Municipality, Porto District, 4464-513, Portugal

RECRUITING

Instituto Portugês de Oncologia de Coimbra Francisco Gentil-Oncologia Médica ( Site 2704)

Coimbra, 3000-075, Portugal

RECRUITING

Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2702)

Porto, 4200-072, Portugal

RECRUITING

MEMORIAL HEALTHCARE INTERNATIONAL S.R.L.. ( Site 2803)

Bucharest, Bucharest, 013823, Romania

RECRUITING

Cardiomed SRL Cluj-Napoca-Medical Oncology ( Site 2801)

Cluj-Napoca, Cluj, 400015, Romania

COMPLETED

SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2802)

Florești, Cluj, 407280, Romania

RECRUITING

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2805)

Craiova, Dolj, 200542, Romania

COMPLETED

Spitalul Clinic Municipal De Urgenta Timisoara ( Site 2806)

Timișoara, Timiș County, 300595, Romania

RECRUITING

SC ONCO CARD SRL ( Site 2808)

Brasov, 500052, Romania

RECRUITING

SC MNT HEALTHCARE EUROPE SRL ( Site 2811)

Bucharest, 013975, Romania

RECRUITING

Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu ( Site 2804)

Bucharest, 077015, Romania

RECRUITING

Institutul Regional de Oncologie ( Site 2807)

Iași, 700483, Romania

RECRUITING

National Cancer Center-Lung Cancer Center ( Site 1002)

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

RECRUITING

Seoul National University Bundang Hospital-Medical Oncology ( Site 1003)

Seongnam, Kyonggi-do, 13620, South Korea

RECRUITING

The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1001)

Suwon, Kyonggi-do, 16247, South Korea

RECRUITING

Chungbuk National University Hospital-Internal medicine ( Site 1000)

Cheongju-si, North Chungcheong, 28644, South Korea

RECRUITING

Keimyung University Dongsan Hospital CRC room 1 ( Site 1006)

Daegu, Taegu-Kwangyokshi, 42601, South Korea

RECRUITING

Asan Medical Center-Lung Cancer Center ( Site 1005)

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center-Division of Hematology/Oncology ( Site 1004)

Seoul, 06351, South Korea

RECRUITING

Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2901)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2905)

Santiago de Compostela, La Coruna, 15706, Spain

RECRUITING

Hospital Insular de Gran Canaria-Oncology ( Site 2903)

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

RECRUITING

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2902)

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2900)

Barcelona, 08035, Spain

RECRUITING

Hospital Clinico San Carlos-Oncology Department ( Site 2904)

Madrid, 28040, Spain

RECRUITING

CHUV (centre hospitalier universitaire vaudois) ( Site 3003)

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Kantonsspital Graubünden-Medizin ( Site 3006)

Chur, Kanton Graubünden, 7000, Switzerland

RECRUITING

Kantonsspital Münsterlingen - Spital Thurgau AG ( Site 3005)

Münsterlingen, Thurgau, 8596, Switzerland

RECRUITING

HFR Fribourg - Hôpital Cantonal ( Site 3004)

Fribourg, 1708, Switzerland

RECRUITING

National Taiwan University Cancer Center (NTUCC) ( Site 1105)

Taipei City, Taipei, 106, Taiwan

RECRUITING

Tri-Service General Hospital ( Site 1100)

Taipei City, Taipei, 114, Taiwan

RECRUITING

Taoyuan General Hospital ( Site 1106)

Taoyuan City, Taoyuan, 33004, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1103)

Kaohsiung City, 807, Taiwan

RECRUITING

Taichung Veterans General Hospital-Chest ( Site 1101)

Taichung, 40705, Taiwan

RECRUITING

National Cheng Kung University Hospital-Clinical Trial Center ( Site 1102)

Tainan, 704, Taiwan

COMPLETED

National Taiwan University Hospital-Oncology ( Site 1104)

Taipei, 10002, Taiwan

RECRUITING

Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 3106)

Adana, 01140, Turkey (Türkiye)

RECRUITING

Gulhane Egitim Arastirma Hastanesi-Onkoloji ( Site 3104)

Ankara, 06010, Turkey (Türkiye)

RECRUITING

Hacettepe Universite Hastaneleri-oncology hospital ( Site 3101)

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Memorial Ankara Hastanesi-Medical Oncology ( Site 3110)

Ankara, 06520, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 3103)

Ankara, 06800, Turkey (Türkiye)

RECRUITING

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3107)

Istanbul, 34722, Turkey (Türkiye)

RECRUITING

Erciyes Universitesi Tıp Fakultesi Hastanesi ( Site 3111)

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

Addenbrooke's Hospital ( Site 3217)

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

RECRUITING

Mount Vernon Hospital ( Site 3218)

Northwood, Hillingdon, HA6 2RN, United Kingdom

RECRUITING

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3203)

London, London, City of, EC1A 7BE, United Kingdom

RECRUITING

Churchill Hospital ( Site 3219)

Oxford, Oxfordshire, OX3 7LE, United Kingdom

RECRUITING

Freeman Hospital-Northern Centre for Cancer Care ( Site 3212)

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma; Lung Neoplasms

Interventions

pembrolizumab; Cisplatin; Pemetrexed; Gemcitabine; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

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

Model Details: This is a multi site study

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: April 3, 2024
• Primary Completion (Estimated): February 21, 2034
• Study Completion (Estimated): October 23, 2034
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

GR (8); HK (3); ME (6); AU (4); CH (4); DE (12); CA (4); AR (7); US (49); GB (5); KR (7); NO (4); FR (10); TU (7); ES (6); CN (27); CZ (2); PL (9); IT (14); TW (7); RO (9); NL (8); BE (3); BR (7); PT (4); CL (5); PE (5); JP (20); IL (4); NZ (1)