A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)

NCT06623422 | Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: V940-0092023-506327-29-00U1111-1293-5814INTerpath-009jRCT2061240105
• Study Type: interventional
• Target: 680
• Locations: 31 countries
• Sites: 231

Brief Summary

The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1); Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2); Individualized neoantigen therapy (INT)

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival (DFS)

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

  Up to ~97 months

Secondary Outcomes (9)

• Overall Survival (OS)

  Up to ~129 months

• Distant Metastasis-Free Survival (DMFS)

  Up to ~129 months

• Disease-Free Survival 2 (DFS2)

  Up to ~129 months

• Lung Cancer Specific Survival (LCSS)

  Up to ~129 months

• Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30)

  Baseline and up to ~129 months

Study Arms (2)

Pembrolizumab + Intismeran autogene

EXPERIMENTAL

For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via intravenous (IV) infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC\] 5 or 6 mg/mL/min, pemetrexed 500 mg/m\^2, gemcitabine 1000 mg/m\^2, paclitaxel 175 mg/m\^2 or 200 mg/m\^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to \~12 weeks). After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS intismeran autogene 1 mg via intramuscular (IM) injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to \~42 weeks).

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

Pembrolizumab + Placebo

ACTIVE COMPARATOR

For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via IV infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m\^2 or carboplatin AUC 5 or 6 mg/mL/min, pemetrexed 500 mg/m\^2, gemcitabine 1000 mg/m\^2, paclitaxel 175 mg/m\^2 or 200 mg/m\^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to \~12 weeks). After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS matching placebo via IM injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to \~42 weeks).

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

Interventions

Pembrolizumab BIOLOGICAL

IV Infusion

Also known as: MK-3475, KEYTRUDA®

Pembrolizumab + Intismeran autogene; Pembrolizumab + Placebo

Cisplatin DRUG

IV infusion

Also known as: Platinol®, Platinol®-AQ

Pembrolizumab + Intismeran autogene; Pembrolizumab + Placebo

Carboplatin DRUG

IV infusion

Also known as: Paraplatin®

Pembrolizumab + Intismeran autogene; Pembrolizumab + Placebo

Intismeran autogene BIOLOGICAL

IM injection

Also known as: mRNA-4157, V940

Pembrolizumab + Intismeran autogene

Pemetrexed DRUG

IV infusion

Also known as: Alimta®

Pembrolizumab + Intismeran autogene; Pembrolizumab + Placebo

Gemcitabine DRUG

IV infusion

Also known as: Gemzar

Pembrolizumab + Intismeran autogene; Pembrolizumab + Placebo

Paclitaxel DRUG

IV infusion

Also known as: Taxol®, Onxol®

Pembrolizumab + Intismeran autogene; Pembrolizumab + Placebo

Placebo OTHER

IM injection

Pembrolizumab + Placebo

Eligibility Criteria

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

You may qualify if:

• Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \[American Joint Committee on Cancer (AJCC) 8th Edition\]
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
• Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
• Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \[eg, DEL19 or L858R\])
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral 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 prior to randomization
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

You may not qualify if:

• Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor
• Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
• Received prior neoadjuvant therapy for their current NSCLC diagnosis
• Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein \[CTLA-4\], OX-40, CD137)
• Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol
• Received prior treatment with a cancer vaccine
• Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• ModernaTX, Inc.: collaborator

Study Sites (231)

Banner MD Anderson Cancer Center ( Site 0181)

Gilbert, Arizona, 85234, United States

RECRUITING

The University of Arizona Cancer Center - North Campus ( Site 0163)

Tucson, Arizona, 85719, United States

RECRUITING

Providence St. Jude Medical Center ( Site 0106)

Fullerton, California, 92835, United States

RECRUITING

VA Long Beach Healthcare System ( Site 0199)

Long Beach, California, 90822, United States

RECRUITING

USC Norris Comprehensive Cancer Center ( Site 0205)

Los Angeles, California, 90033, United States

RECRUITING

UCSF Medical Center at Mission Bay ( Site 0178)

San Francisco, California, 94158, United States

RECRUITING

University of Colorado Anschutz Medical Campus ( Site 0151)

Aurora, Colorado, 80045, United States

RECRUITING

UCHealth Memorial Hospital Central ( Site 0125)

Colorado Springs, Colorado, 80909, United States

RECRUITING

Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)

Greeley, Colorado, 80631, United States

RECRUITING

Centura Health - St. Anthony North Health Campus ( Site 0189)

Westminster, Colorado, 80023, United States

RECRUITING

Yale University School of Medicine ( Site 0201)

New Haven, Connecticut, 06510, United States

RECRUITING

Eastern CT Hematology & Oncology Associates ( Site 0202)

Norwich, Connecticut, 06360, United States

RECRUITING

The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156)

Fort Lauderdale, Florida, 33316, United States

RECRUITING

Miami Cancer Institute at Baptist Health, Inc. ( Site 0214)

Miami, Florida, 33176, United States

RECRUITING

Beacon Cancer Care ( Site 0127)

Post Falls, Idaho, 83854, United States

RECRUITING

The University of Chicago Medical Center ( Site 0118)

Chicago, Illinois, 60637, United States

RECRUITING

Maryland Oncology Hematology (MOH) ( Site 8102)

Rockville, Maryland, 20850, United States

RECRUITING

Massachusetts General Hospital ( Site 0136)

Boston, Massachusetts, 02114, United States

RECRUITING

Dana Farber Cancer Hospital ( Site 0155)

Boston, Massachusetts, 02215, United States

RECRUITING

Ellis Fischel Cancer Center ( Site 0133)

Columbia, Missouri, 65212, United States

COMPLETED

Lake Regional Hospital-Cancer Center ( Site 0123)

Osage Beach, Missouri, 65065, United States

COMPLETED

Roswell Park Cancer Institute ( Site 0184)

Buffalo, New York, 14263, United States

RECRUITING

Hematology-Oncology Associates of CNY ( Site 0164)

East Syracuse, New York, 13057, United States

RECRUITING

The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216)

New York, New York, 10011, United States

RECRUITING

Icahn School of Medicine at Mount Sinai ( Site 0116)

New York, New York, 10029, United States

RECRUITING

Memorial Sloan Kettering Cancer Center ( Site 0137)

New York, New York, 10065, United States

RECRUITING

SUNY Upstate Cancer Center ( Site 0140)

Syracuse, New York, 13210, United States

RECRUITING

Montefiore Medical Center ( Site 0160)

The Bronx, New York, 10461, United States

RECRUITING

Westchester Medical Center ( Site 0196)

Valhalla, New York, 10595, United States

RECRUITING

Novant Health Weisiger Cancer Insititute ( Site 0266)

Charlotte, North Carolina, 28204, United States

RECRUITING

Novant Health Forsyth Medical Center ( Site 0166)

Winston-Salem, North Carolina, 27103, United States

RECRUITING

University of Cincinnati Medical Center ( Site 0119)

Cincinnati, Ohio, 45219, United States

RECRUITING

St. Lukes Hospital and Health Network ( Site 0186)

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

Thompson Cancer Survival Center ( Site 0168)

Knoxville, Tennessee, 37916, United States

RECRUITING

Elliston Place Medical Oncology & Hematology ( Site 0215)

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - DFW ( Site 8103)

Dallas, Texas, 75246, United States

RECRUITING

UT Southwestern Medical Center ( Site 0190)

Dallas, Texas, 75390, United States

RECRUITING

Houston Methodist Cancer Center ( Site 0191)

Houston, Texas, 77030, United States

RECRUITING

MD Anderson Cancer Center ( Site 0150)

Houston, Texas, 77030, United States

RECRUITING

Memorial Hermann Cancer Center ( Site 0172)

Houston, Texas, 77030, United States

RECRUITING

Michael E. DeBakey VA Medical Center ( Site 0197)

Houston, Texas, 77030, United States

RECRUITING

O'Quinn Medical Tower at McNair Campus ( Site 0131)

Houston, Texas, 77030, United States

RECRUITING

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)

Tyler, Texas, 75701, United States

RECRUITING

Virginia Cancer Specialists ( Site 0167)

Fairfax, Virginia, 22031, United States

RECRUITING

Virginia Oncology Associates (VOA) ( Site 8101)

Norfolk, Virginia, 23502, United States

RECRUITING

VCU Health Adult Outpatient Pavillion ( Site 0193)

Richmond, Virginia, 23219, United States

RECRUITING

Swedish Cancer Institute ( Site 0143)

Seattle, Washington, 98104, United States

RECRUITING

Virginia Mason Franciscan Health - St. Michael Cancer Center ( Site 0192)

Silverdale, Washington, 98383, United States

RECRUITING

CEMIC ( Site 2454)

Caba., Buenos Aires, C1431FWO, Argentina

RECRUITING

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2459)

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

RECRUITING

Fundacion Intecnus ( Site 2456)

Bariloche, Río Negro Province, R8402APU, Argentina

RECRUITING

Centro Médico IPAM ( Site 2452)

Rosario, Santa Fe Province, S2001SBK, Argentina

RECRUITING

Instituto Medico Especializado Alexander Fleming ( Site 2457)

Buenos Aires, C1426ANZ, Argentina

RECRUITING

Instituto Oncologico de Cordoba -IONC ( Site 2455)

Córdoba, X5001HWE, Argentina

RECRUITING

Calvary Mater Newcastle ( Site 2106)

Waratah, New South Wales, 2298, Australia

RECRUITING

Tasman Oncology Research ( Site 2104)

Southport, Queensland, 4215, Australia

COMPLETED

Princess Alexandra Hospital ( Site 2102)

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Grampians Health ( Site 2101)

Ballarat, Victoria, 3350, Australia

RECRUITING

One Clinical Research ( Site 2103)

Nedlands, Western Australia, 6009, Australia

RECRUITING

Cliniques Universitaires Saint-Luc ( Site 1203)

Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

RECRUITING

Jessa Ziekenhuis ( Site 1204)

Hasselt, Limburg, 3500, Belgium

RECRUITING

UZ Gent ( Site 1201)

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 2502)

Fortaleza, Ceará, 60336-550, Brazil

RECRUITING

Liga Norte Riograndense Contra o Cancer ( Site 2513)

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

RECRUITING

Hospital Tacchini ( Site 2506)

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

RECRUITING

Hospital de Clínicas de Passo Fundo ( Site 2504)

Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

RECRUITING

Hospital Moinhos de Vento ( Site 2510)

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

RECRUITING

Hospital Nossa Senhora Da Conceicao ( Site 2512)

Porto Alegre, Rio Grande do Sul, 91359-200, Brazil

RECRUITING

Instituto de Oncologia Saint Gallen ( Site 2507)

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

RECRUITING

Hospital de Amor - Barretos ( Site 2511)

Barretos, São Paulo, 14784-400, Brazil

RECRUITING

Instituto Nacional de Câncer - INCA ( Site 2501)

Rio de Janeiro, 20230-130, Brazil

RECRUITING

MBAL Uni Hospital ( Site 1253)

Panagyurishte, Pazardzhik, 4500, Bulgaria

RECRUITING

MHAT - Heart and Brain ( Site 1252)

Pleven, 5800, Bulgaria

RECRUITING

Queen Elizabeth II Health Sciences Centre ( Site 1101)

Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

Hamilton Health Sciences - Juravinski Site ( Site 1104)

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1105)

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

Lakeridge Health ( Site 1107)

Oshawa, Ontario, L1G 2B9, Canada

RECRUITING

Sunnybrook Research Institute ( Site 1106)

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

McGill University Health Centre ( Site 1103)

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

IUCPQ ( Site 1112)

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Orlandi Oncologia ( Site 2555)

Santiago, Region M. de Santiago, 7500713, Chile

RECRUITING

FALP ( Site 2551)

Santiago, Region M. de Santiago, 7500921, Chile

RECRUITING

Clínica RedSalud Vitacura ( Site 2556)

Santiago, Region M. de Santiago, 7650018, Chile

RECRUITING

Bradfordhill ( Site 2552)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

ONCOCENTRO APYS ( Site 2554)

Viña del Mar, Valparaiso, 2520598, Chile

RECRUITING

Bradford Hill Norte ( Site 2563)

Antofagasta, 1263521, Chile

RECRUITING

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2603)

Bogotá, Bogota D.C., 110131, Colombia

RECRUITING

Hospital Universitario San Ignacio ( Site 2610)

Bogotá, Bogota D.C., 110231, Colombia

RECRUITING

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 2604)

Bogotá, Bogota D.C., 111321, Colombia

RECRUITING

IMAT S.A.S ( Site 2602)

Montería, Departamento de Córdoba, 230002, Colombia

RECRUITING

Oncologos del Occidente ( Site 2608)

Pereira, Risaralda Department, 660001, Colombia

RECRUITING

Fundacion Valle del Lili- CIC ( Site 2601)

Cali, Valle del Cauca Department, 760032, Colombia

COMPLETED

Oulun yliopistollinen sairaala ( Site 1301)

Oulu, Northern Savonia, 90220, Finland

RECRUITING

Turku University Hospital ( Site 1303)

Turku, Southwest Finland, 20520, Finland

RECRUITING

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1354)

Tours, Centre-Val de Loire, 3700, France

RECRUITING

CHU Besançon ( Site 1358)

Besançon, Franche-Comte, 25000, France

COMPLETED

Institut De Cancerologie De L Ouest ( Site 1357)

Saint-Herblain, Loire-Atlantique, 44800, France

RECRUITING

Institut Cœur Poumon -CHU Lille ( Site 1352)

Lille, Nord, 59037, France

RECRUITING

CENTRE LEON BERARD ( Site 1351)

Lyon, Rhone, 69008, France

RECRUITING

Pitie Salpetriere University Hospital ( Site 1355)

Paris, 75013, France

RECRUITING

Gustave Roussy ( Site 1353)

Villejuif, Île-de-France Region, 94805, France

RECRUITING

Thoraxklinik-Heidelberg gGmbH ( Site 1412)

Heidelberg, Baden-Wurttemberg, 69126, Germany

RECRUITING

Robert-Bosch-Krankenhaus ( Site 1401)

Stuttgart, Baden-Wurttemberg, 70736, Germany

RECRUITING

Klinikverbund Allgäu gGmbH ( Site 1408)

Kempten (Allgäu), Bavaria, 87439, Germany

RECRUITING

UKGM Gießen/Marburg ( Site 1404)

Giessen, Hesse, 35392, Germany

RECRUITING

Pius Hospital Oldenburg ( Site 1407)

Oldenburg, Lower Saxony, 26121, Germany

RECRUITING

St.-Antonius-Hospital ( Site 1411)

Eschweiler, North Rhine-Westphalia, 52249, Germany

RECRUITING

Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1405)

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Marienhaus Klinikum Mainz ( Site 1403)

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1452)

Pátrai, Achaia, 265 04, Greece

RECRUITING

Errikos Dunant Hospital Center ( Site 1457)

Athens, Attica, 115 26, Greece

RECRUITING

THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1451)

Athens, Attica, 115 27, Greece

RECRUITING

Metropolitan Hospital ( Site 1459)

Athens, Attica, 185 47, Greece

RECRUITING

ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1460)

Chaïdári, Attica, 124 62, Greece

RECRUITING

University General Hospital of Herakleion ( Site 1458)

Heraklion, Irakleio, 715 00, Greece

RECRUITING

University General Hospital of Larissa-Oncology Clinic ( Site 1453)

Larissa, Thessaly, 411 10, Greece

RECRUITING

Papageorgiou General Hospital of Thessaloniki ( Site 1454)

Thessaloniki, 564 29, Greece

RECRUITING

Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 1506)

Székesfehérvár, Fejér, 8000, Hungary

RECRUITING

Petz Aladár Megyei Oktató Kórház ( Site 1502)

Győr, Győr-Moson-Sopron, 9024, Hungary

RECRUITING

Debreceni Egyetem Altalanos Orvostudomanyi Kar Tudogyogyaszati Tanszek ( Site 1508)

Debrecen, Hajdú-Bihar, 4032, Hungary

RECRUITING

Mátrai Gyógyintézet ( Site 1504)

Mátraháza, Heves County, 3233, Hungary

RECRUITING

Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1505)

Törökbálint, Pest County, 2045, Hungary

RECRUITING

Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1507)

Kaposvár, Somogy County, 7400, Hungary

RECRUITING

Orszagos Koranyi Pulmonologiai Intezet ( Site 1501)

Budapest, 1121, Hungary

RECRUITING

Cork University Hospital ( Site 1553)

Cork, T12 E8YV, Ireland

RECRUITING

St. James's Hospital ( Site 1554)

Dublin, 8, Ireland

RECRUITING

Tallaght University Hospital ( Site 1551)

Dublin, D24 NR0A, Ireland

RECRUITING

Rambam Health Care Campus ( Site 1603)

Haifa, 3109601, Israel

RECRUITING

Shaare Zedek Medical Center ( Site 1601)

Jerusalem, 9103102, Israel

RECRUITING

Hadassah Medical Center ( Site 1605)

Jerusalem, 9112001, Israel

RECRUITING

Meir Medical Center ( Site 1606)

Kfar Saba, 4428164, Israel

RECRUITING

Sheba Medical Center ( Site 1602)

Ramat Gan, 5265601, Israel

RECRUITING

AOU Renato Dulbecco ( Site 1661)

Catanzaro, Calabria, 88100, Italy

RECRUITING

Ospedale Santa Maria delle Croci ( Site 1652)

Ravenna, Emilia-Romagna, 48121, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1653)

Rome, Lazio, 00168, Italy

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1660)

Rome, Roma, 00128, Italy

RECRUITING

Istituto Nazionale Tumori Regina Elena ( Site 1651)

Rome, Roma, 00128, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1656)

Milan, 20133, Italy

RECRUITING

IEO Istituto Europeo di Oncologia ( Site 1655)

Milan, 20141, Italy

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1657)

Naples, 80131, Italy

RECRUITING

IRCCS Istituto Oncologico Veneto ( Site 1654)

Padova, 35128, Italy

RECRUITING

Centro Ricerche Cliniche di Verona ( Site 1659)

Verona, 37134, Italy

RECRUITING

Hospital of the University of Occupational and Environmental Health, Japan ( Site 1166)

Kitakyushu, Fukuoka, 807-8556, Japan

RECRUITING

St. Marianna University Hospital ( Site 1159)

Kawasaki, Kanagawa, 216-8511, Japan

RECRUITING

Kanagawa Cancer Center ( Site 1158)

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Kindai University Hospital ( Site 1162)

Sakai, Osaka, 590-0197, Japan

RECRUITING

Shizuoka Cancer Center ( Site 1160)

Sunto-gun, Shizuoka, 411-8777, Japan

RECRUITING

Dokkyo Medical University Hospital ( Site 1152)

Shimotsuga-gun, Tochigi, 321-0293, Japan

RECRUITING

National Cancer Center Hospital ( Site 1156)

Chūō, Tokyo, 104-0045, Japan

RECRUITING

Tokyo Medical University Hospital ( Site 1157)

Shinjuku, Tokyo, 160-0023, Japan

RECRUITING

Chiba University Hospital ( Site 1154)

Chiba, 260-8677, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center ( Site 1167)

Fukuoka, 811-1395, Japan

RECRUITING

Fukushima Medical University Hospital ( Site 1151)

Fukushima, 960-1295, Japan

RECRUITING

Hiroshima University Hospital ( Site 1165)

Hiroshima, 734-8551, Japan

RECRUITING

Okayama University Hospital ( Site 1164)

Okayama, 700-8558, Japan

RECRUITING

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1161)

Osaka, 541-8567, Japan

RECRUITING

Wakayama Medical University Hospital ( Site 1163)

Wakayama, 641-8510, Japan

RECRUITING

Radboudumc ( Site 1706)

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Maastricht UMC+ ( Site 1705)

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

Jeroen Bosch Hospital ( Site 1701)

's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands

RECRUITING

Medisch Centrum Leeuwarden ( Site 1702)

Leeuwarden, Provincie Friesland, 8901 BR, Netherlands

RECRUITING

Meander Medisch Centrum ( Site 1703)

Amersfoort, Utrecht, 3813 TZ, Netherlands

RECRUITING

University Medical Center Groningen ( Site 1707)

Groningen, 9713 GZ, Netherlands

RECRUITING

Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 2201)

Tauranga, Bay of Plenty, 3112, New Zealand

RECRUITING

Dunedin Hospital ( Site 2202)

Dunedin, Otago, 9016, New Zealand

RECRUITING

Waikato Hospital ( Site 2204)

Hamilton, Waikato Region, 3204, New Zealand

RECRUITING

Aliada ( Site 2753)

Lima, 15036, Peru

RECRUITING

Clínica Internacional - Sede San Borja ( Site 2752)

Lima, 15036, Peru

RECRUITING

Detecta Clínica ( Site 2751)

Lima, 15038, Peru

RECRUITING

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1763)

Poznan, Greater Poland Voivodeship, 60-569, Poland

RECRUITING

Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 1756)

Krakow, Lesser Poland Voivodeship, 31-202, Poland

RECRUITING

Instytut Gruźlicy i Chorób Płuc w Warszawie ( Site 1764)

Warsaw, Masovian Voivodeship, 01-138, Poland

RECRUITING

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1759)

Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne ( Site 1758)

Gdansk, Pomeranian Voivodeship, 80-214, Poland

RECRUITING

Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie ( Site 1760)

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

RECRUITING

Swietokrzyskie Centrum Onkologii. ( Site 1754)

Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

RECRUITING

Centrul Medical Medicover Victoria ( Site 1802)

Bucharest, Bucharest, 010626, Romania

RECRUITING

Cabinet Medical Oncomed ( Site 1803)

Timișoara, Timiș County, 300239, Romania

RECRUITING

S.C. ONCO CARD S.R.L ( Site 1805)

Brasov, 500052, Romania

RECRUITING

Institutul Regional de Oncologie ( Site 1804)

Iași, 700483, Romania

RECRUITING

National Cancer Centre Singapore ( Site 2251)

Singapore, Central Singapore, 168583, Singapore

RECRUITING

Tan Tock Seng Hospital ( Site 2252)

Singapore, Central Singapore, 308433, Singapore

RECRUITING

National Cancer Center ( Site 2305)

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

RECRUITING

The Catholic University of Korea St. Vincent s Hospital ( Site 2301)

Suwon, Kyonggi-do, 16247, South Korea

RECRUITING

Ajou University Hospital ( Site 2306)

Suwon, Kyonggi-do, 16499, South Korea

RECRUITING

Seoul National University Hospital ( Site 2303)

Seoul, 03080, South Korea

RECRUITING

Severance Hospital Yonsei University Health System ( Site 2302)

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center ( Site 2304)

Seoul, 06351, South Korea

RECRUITING

Seoul St. Mary's Hospital ( Site 2307)

Seoul, 06591, South Korea

RECRUITING

Hospital Insular de Gran Canaria ( Site 1911)

Canarias, Canary Islands, 35016, Spain

RECRUITING

Complejo Hospitalario Universitario A Coruna ( Site 1916)

A Coruña, La Coruna, 15006, Spain

RECRUITING

Hospital Universitario Quiron Madrid ( Site 1913)

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Hospital Universitari Vall D Hebron ( Site 1910)

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona ( Site 1919)

Barcelona, 08036, Spain

RECRUITING

Hospital General Universitario Gregorio Maranon ( Site 1912)

Madrid, 28009, Spain

RECRUITING

Hospital Quiron Malaga ( Site 1914)

Málaga, 29004, Spain

RECRUITING

Karolinska Universitetssjukhuset Solna ( Site 1951)

Stockholm, Stockholm County, 171 64, Sweden

RECRUITING

Chung Shan Medical University Hospital ( Site 2351)

Taichung, 40201, Taiwan

RECRUITING

China Medical University Hospital ( Site 2358)

Taichung, 40447, Taiwan

RECRUITING

National Cheng Kung University Hospital ( Site 2354)

Tainan, 704302, Taiwan

RECRUITING

National Taiwan University Cancer Center (NTUCC) ( Site 2360)

Taipei, 10002, Taiwan

RECRUITING

Mackay Memorial Hospital ( Site 2355)

Taipei, 104217, Taiwan

RECRUITING

Taipei Medical University Hospital ( Site 2352)

Taipei, 11030, Taiwan

RECRUITING

Koo Foundation Sun Yat-Sen Cancer Center ( Site 2359)

Taipei, 112, Taiwan

RECRUITING

Taipei Veterans General Hospital ( Site 2357)

Taipei, 112, Taiwan

RECRUITING

Chang Gung Memorial Hospital ( Site 2361)

Taoyuan, 333, Taiwan

RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 2403)

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Ramathibodi Hospital ( Site 2405)

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

Faculty of Medicine - Khon Kaen University ( Site 2401)

Muang, Changwat Khon Kaen, 40002, Thailand

RECRUITING

Songklanagarind Hospital ( Site 2402)

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

Maharaj Nakorn Chiang Mai Hospital ( Site 2404)

Muang, Chiang Mai, 50200, Thailand

RECRUITING

Hacettepe Universite Hastaneleri ( Site 2001)

Sıhhiye, Ankara, 06230, Turkey (Türkiye)

RECRUITING

Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2006)

Adapazarı, Sakarya, 54100, Turkey (Türkiye)

RECRUITING

Namık Kemal University Medical Faculty ( Site 2007)

Tekirdağ, Tekirdas, 59100, Turkey (Türkiye)

RECRUITING

Adana Medical Park Seyhan Hastanesi ( Site 2010)

Adana, 01140, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Sehir Hastanesi ( Site 2002)

Ankara, 06800, Turkey (Türkiye)

RECRUITING

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2003)

Istanbul, 34722, Turkey (Türkiye)

RECRUITING

Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 2009)

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

Karadeniz Technical University ( Site 2008)

Trabzon, 61080, Turkey (Türkiye)

RECRUITING

Bristol Haematology and Oncology Centre ( Site 2072)

Bristol, Bristol, City of, BS2 8ED, United Kingdom

RECRUITING

ROYAL MARSDEN HOSPITAL (CHELSEA)-Lung Unit ( Site 2075)

London, Kensington and Chelsea, SW3 6JJ, United Kingdom

RECRUITING

St Bartholomews Hospital ( Site 2052)

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

RECRUITING

Royal Free Hospital ( Site 2074)

London, London, City of, NW3 2QG, United Kingdom

RECRUITING

Guys Hospital ( Site 2057)

London, London, City of, SE1 3SS, United Kingdom

RECRUITING

Royal Marsden Hospital (Sutton) ( Site 2076)

London, London, City of, SW3 6JJ, United Kingdom

RECRUITING

Nottingham City Hospital ( Site 2058)

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

RECRUITING

St James University Hospital ( Site 2055)

Leeds, LS9 7TF, United Kingdom

RECRUITING

Leicester Royal Infirmary ( Site 2051)

Leicester, LE1 5WW, United Kingdom

RECRUITING

The Christie NHS Foundation Trust ( Site 2066)

Manchester, M20 4BX, United Kingdom

RECRUITING

The Clatterbridge Cancer Centre ( Site 2069)

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

RECRUITING

Queen Alexandra Hospital ( Site 2059)

Portsmouth, PO6 3LY, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; Cisplatin; Carboplatin; Pemetrexed; Gemcitabine; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; 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; 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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: October 2, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): May 16, 2033
• Study Completion (Estimated): January 26, 2038
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

BR (9); HU (7); US (48); IL (5); NZ (3); PL (7); CA (7); PE (3); NL (6); DE (8); TH (5); JP (15); BU (2); CL (6); IE (3); RO (4); FR (7); GB (12); FI (2); AR (6); CO (6); AU (5); SG (2); KR (7); ES (7); BE (3); IT (10); TW (9); GR (8); TU (8); SE (1)