A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248 | Recruiting Phase 3 DMC FDA Drug

• 6 other identifiers: 1084-007U1111-1307-95692024-514500-14-00MK-1084-007KANDLELIT-007jRCT2031240722
• Study Type: interventional
• Target: 675
• Locations: 28 countries
• Sites: 178

Brief Summary

Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation. The goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%

  PFS is defined as the time from randomization until either documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PFS as determined by blinded independent central review (BICR) will be presented.

  Up to approximately 48 months

Secondary Outcomes (16)

• PFS in All Participants

  Up to approximately 48 months

• Overall Survival (OS) in Participants with PD-L1 TPS ≥1%

  Up to approximately 62 months

• OS in Participants in All Participants

  Up to approximately 62 months

• Overall Response Rate (ORR) in All Participants

  Up to approximately 48 months

• ORR in Participants with PD-L1 TPS ≥1%

  Up to approximately 48 months

Study Arms (2)

Calderasib + Pembrolizumab (+) Berahyaluronidase alfa

EXPERIMENTAL

Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) plus calderasib until discontinuation criterion is met.

Drug: Calderasib; Biological: Pembrolizumab (+) Berahyaluronidase alfa

Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy

ACTIVE COMPARATOR

Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) and pemetrexed via intravenous (IV) infusion at a dose of 500 mg/m\^2 on days 1 and 22 of cycles 1 and 3 until discontinuation criterion is met PLUS investigator's choice of carboplatin via IV infusion at area under curve (AUC) 5 mg/mL/minute on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks) OR cisplatin via IV infusion at a dose of 75 mg/m\^2 on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks).

Biological: Pembrolizumab (+) Berahyaluronidase alfa; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

Interventions

Pemetrexed DRUG

Administered as an IV Infusion

Also known as: Alimta

Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy

Cisplatin DRUG

Administered as an IV Infusion

Also known as: Platinol-AQ

Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy

Pembrolizumab (+) Berahyaluronidase alfa BIOLOGICAL

Administered as a SC injection

Also known as: MK-3475A

Calderasib + Pembrolizumab (+) Berahyaluronidase alfa; Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy

Calderasib DRUG

Administered as an oral tablet

Also known as: MK-1084

Calderasib + Pembrolizumab (+) Berahyaluronidase alfa

Carboplatin DRUG

Administered as an IV Infusion

Also known as: PARAPLATIN®

Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c
• If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)

You may not qualify if:

• Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
• Has a gastrointestinal disorder affecting absorption
• Is HIV positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC
• Has known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has active autoimmune disease that has required systemic treatment in the past 2 years
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has active infection requiring systemic therapy except those specified by protocol
• Has history of stem cell/solid organ transplant
• Has not adequately recovered from major surgery or has ongoing surgical complications

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (181)

Central Alabama Research ( Site 0108)

Birmingham, Alabama, 35209, United States

RECRUITING

Stamford Hospital ( Site 0126)

Stamford, Connecticut, 06902, United States

RECRUITING

Mount Sinai Cancer Center ( Site 0137)

Miami Beach, Florida, 33140, United States

COMPLETED

Indiana University Health Arnett Cancer Center ( Site 0116)

Lafayette, Indiana, 47904, United States

RECRUITING

New England Cancer Specialists ( Site 0139)

Westbrook, Maine, 04092, United States

RECRUITING

New York Oncology Hematology, P.C. ( Site 0119)

Albany, New York, 12206, United States

RECRUITING

St. Charles Health System, Inc ( Site 0146)

Bend, Oregon, 97701, United States

RECRUITING

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)

Lancaster, Pennsylvania, 17601, United States

RECRUITING

Blue Ridge Cancer Care ( Site 0144)

Roanoke, Virginia, 24014, United States

RECRUITING

Instituto Alexander Fleming ( Site 0311)

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

RECRUITING

Hospital Italiano de Cordoba ( Site 0308)

Córdoba, 5000, Argentina

RECRUITING

CEMAIC ( Site 0309)

Córdoba, X5008AAC, Argentina

RECRUITING

Genesis Care- Campbelltown ( Site 2907)

Campbelltown, New South Wales, 2560, Australia

RECRUITING

Northern Beaches Hospital ( Site 2905)

Frenchs Forest, New South Wales, 2086, Australia

RECRUITING

The Prince Charles Hospital ( Site 2903)

Brisbane, Queensland, 4032, Australia

RECRUITING

Mater Hospital Brisbane ( Site 2906)

South Brisbane, Queensland, 4101, Australia

RECRUITING

Klinikum Klagenfurt am Wörthersee ( Site 1002)

Klagenfurt, Carinthia, 9020, Austria

RECRUITING

Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1005)

Graz, Styria, 8036, Austria

RECRUITING

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1001)

Vienna, 1210, Austria

RECRUITING

Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3903)

Genk, Limburg, 3600, Belgium

RECRUITING

CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0412)

Fortaleza, Ceará, 60336-232, Brazil

RECRUITING

Hospital Santa Rita de Cassia ( Site 0403)

Vitória, Espírito Santo, 29043-260, Brazil

RECRUITING

Real Hospital Portugues ( Site 0418)

Recife, Pernambuco, 52010075, Brazil

RECRUITING

Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa ( Site 0400)

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

RECRUITING

CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0410)

Florianópolis, Santa Catarina, 88020-210, Brazil

RECRUITING

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto USP ( Site 0419)

Ribeirão Preto, São Paulo, 14048-900, Brazil

RECRUITING

Faculdade de Medicina do ABC ( Site 0411)

Santo André, São Paulo, 09060-870, Brazil

RECRUITING

Hospital Alemao Oswaldo Cruz ( Site 0413)

São Paulo, São Paulo, 01327-001, Brazil

RECRUITING

IBCC - Núcleo de Pesquisa e Ensino ( Site 0417)

São Paulo, 04014-002, Brazil

RECRUITING

Cross Cancer Institute ( Site 0203)

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

Centro de Estudios Clínicos SAGA ( Site 0503)

Santiago, Region M. de Santiago, 7500653, Chile

RECRUITING

FALP ( Site 0500)

Santiago, Region M. de Santiago, 7500921, Chile

RECRUITING

Bradfordhill ( Site 0501)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

Anhui Provincial Cancer Hospital ( Site 2708)

Hefei, Anhui, 230031, China

RECRUITING

Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2700)

Beijing, Beijing Municipality, 100142, China

RECRUITING

Beijing Peking Union Medical College Hospital ( Site 2702)

Beijing, Beijing Municipality, 100730, China

RECRUITING

The First Affiliated Hospital of Fujian Medical University ( Site 2701)

Fujian, Fujian, 350005, China

RECRUITING

Fujian Provincial Cancer Hospital ( Site 2706)

Fuzhou, Fujian, 350014, China

RECRUITING

The First Affiliated Hospital of Xiamen University ( Site 2717)

Fuzhou, Fujian, 361003, China

RECRUITING

The First Affiliated Hospital.Sun Yat-sen University ( Site 2714)

Guangzhou, Guangdong, 510080, China

RECRUITING

AFFILIATED CANCER HOSPITAL AND INSTITUTE OF GUANGZHOU MEDICAL UNIVERSITY ( Site 2743)

Guangzhou, Guangdong, 510095, China

RECRUITING

Zhujiang Hospital of Southern Medical University ( Site 2744)

Guangzhou, Guangdong, 510280, China

RECRUITING

Affiliated Cancer Hospital of Guangxi Medical University ( Site 2704)

Nanning, Guangxi, 530021, China

RECRUITING

JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 2745)

Jiamusi, Heilongjiang, 154007, China

RECRUITING

Henan Cancer Hospital ( Site 2746)

Zhengzhou, Henan, 450008, China

RECRUITING

Tongji Hospital Tongji Medical,Science & Technology ( Site 2722)

Wuhan, Hubei, 430030, China

RECRUITING

Hubei Cancer Hospital ( Site 2721)

Wuhan, Hubei, 430079, China

RECRUITING

Xiangya Hospital Central South University ( Site 2741)

Changsha, Hunan, 410008, China

RECRUITING

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 2715)

Nanjing, Jiangsu, 210000, China

ACTIVE NOT RECRUITING

Jiangxi Cancer Hospital ( Site 2725)

Nanchang, Jiangxi, 330029, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2729)

Xi'an, Shaanxi, 710061, China

RECRUITING

LinYi Cancer Hospital ( Site 2737)

Linyi, Shandong, 276000, China

RECRUITING

Shanghai Pulmonary Hospital-Oncology Department ( Site 2723)

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Shanxi Cancer Hospital ( Site 2728)

Taiyuan, Shanxi, 030013, China

RECRUITING

Sichuan Cancer Hospital. ( Site 2739)

Chengdu, Sichuan, 610213, China

RECRUITING

West China Hospital Sichuan University ( Site 2735)

Chengdu, Sichuan, 611135, China

RECRUITING

Chongqing University Cancer Hospital ( Site 2736)

Chongqing, Sichuan, 400030, China

RECRUITING

Yunnan Province Cancer Hospital ( Site 2734)

Kunming, Yunnan, 650118, China

RECRUITING

The First Affiliated Hospital, Zhejiang University ( Site 2716)

Hangzhou, Zhejiang, 310003, China

RECRUITING

Sir Run Run Shaw Hospital ( Site 2731)

Hangzhou, Zhejiang, 310015, China

RECRUITING

Zhejiang Cancer Hospital ( Site 2727)

Hangzhou, Zhejiang, 310022, China

RECRUITING

Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2724)

Taizhou, Zhejiang, 317000, China

RECRUITING

Instituto De Cancerologia S.A. ( Site 0608)

Medellín, Antioquia, 050025, Colombia

RECRUITING

Hospital Universitario San Ignacio ( Site 0604)

Bogotá, Bogota D.C., 110231, Colombia

RECRUITING

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0607)

Bogotá, Bogota D.C., 111321, Colombia

RECRUITING

Hopital Europeen Marseille ( Site 1207)

Marseille, Bouches-du-Rhone, 13003, France

RECRUITING

CHU Caen ( Site 1212)

Caen, Calvados, 14000, France

RECRUITING

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1209)

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

RECRUITING

Centre Hospitalier Metropole Savoie Site de Chambery ( Site 1208)

Chambéry, Savoie, 73011, France

RECRUITING

Clinique de l'Europe ( Site 1213)

Amiens, Somme, 80000, France

RECRUITING

Groupe Hospitalier Paris Saint Joseph ( Site 1215)

Paris, 75014, France

RECRUITING

Hôpital Européen Georges Pompidou ( Site 1214)

Paris, 75015, France

RECRUITING

Agios Andreas Hospital Patras ( Site 1407)

Pátrai, Achaia, 263 35, Greece

RECRUITING

Errikos Dunant Hospital Center ( Site 1408)

Athens, Attica, 115 26, Greece

RECRUITING

General Hospital of Athens "Laiko" ( Site 1402)

Athens, Attica, 11526, Greece

RECRUITING

Metropolitan General Hospital ( Site 1400)

Athens, Attica, 155 62, Greece

RECRUITING

Papageorgiou General Hospital of Thessaloniki ( Site 1403)

Thessaloniki, 564 29, Greece

RECRUITING

MEDI-K ( Site 3803)

Guatemala City, 01009, Guatemala

ACTIVE NOT RECRUITING

Centro Integral De Oncologia Gastrointestinal Y Hemato-Oncologia De Guatemala, S. A ( Site 3802)

Guatemala City, 01010, Guatemala

RECRUITING

Servicios Médicos Oncológicos ( Site 3804)

Guatemala City, 1010, Guatemala

RECRUITING

Orszagos Koranyi Pulmonologiai Intezet ( Site 1501)

Budapest, Pest County, 1121, Hungary

RECRUITING

Reformatus Pulmonologiai Centrum ( Site 1503)

Törökbálint, Pest County, 2045, Hungary

RECRUITING

Yitzhak Shamir Medical Center. ( Site 1709)

Beer Ya Akov, 7033001, Israel

RECRUITING

Shaare Zedek Medical Center ( Site 1706)

Jerusalem, 9103102, Israel

RECRUITING

Meir Medical Center. ( Site 1702)

Kfar Saba, 4428164, Israel

RECRUITING

Sheba Medical Center ( Site 1700)

Ramat Gan, 5265601, Israel

RECRUITING

Sourasky Medical Center ( Site 1705)

Tel Aviv, 6423906, Israel

RECRUITING

Azienda Santiaria dell'Alto Adige, comprensorio di Bolzano ( Site 1818)

Bolzano, Bozen, 39100, Italy

RECRUITING

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807)

Meldola, Forli-Cesena, 47014, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1811)

Bergamo, Lombardy, 24127, Italy

RECRUITING

Istituto Clinico Humanitas ( Site 1812)

Rozzano, Milano, 20089, Italy

RECRUITING

Ospedale San Giuseppe Moscati ( Site 1816)

Statte, Taranto, 74010, Italy

RECRUITING

AOU Careggi ( Site 1801)

Florence, Tuscany, 50134, Italy

RECRUITING

AOU Renato Dulbecco ( Site 1804)

Catanzaro, 88100, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda ( Site 1817)

Milan, 20162, Italy

RECRUITING

A.O.R.N. Antonio Cardarelli ( Site 1810)

Naples, 80131, Italy

RECRUITING

Policlinico San Matteo ( Site 1802)

Pavia, 27100, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 1809)

Verona, 37126, Italy

RECRUITING

Aichi Cancer Center ( Site 2813)

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

Fujita Health University Hospital ( Site 2807)

Toyoake, Aichi-ken, 470-1192, Japan

RECRUITING

Hirosaki University Hospital ( Site 2818)

Hirosaki, Aomori, 036-8563, Japan

RECRUITING

Kurume University Hospital ( Site 2815)

Kurume, Fukuoka, 830-0011, Japan

RECRUITING

Gunma Prefectural Cancer Center ( Site 2802)

Ōta, Gunma, 373-8550, Japan

RECRUITING

National Hospital Organization Himeji Medical Center ( Site 2827)

Himeji, Hyōgo, 670-8520, Japan

RECRUITING

Kobe City Medical Center General Hospital ( Site 2811)

Kobe, Hyōgo, 650-0047, Japan

RECRUITING

Takarazuka City Hospital ( Site 2828)

Takarazuka, Hyōgo, 665-0827, Japan

RECRUITING

Kanazawa University Hospital ( Site 2805)

Kanazawa, Ishikawa-ken, 920-8641, Japan

RECRUITING

St. Marianna University Hospital ( Site 2814)

Kawasaki, Kanagawa, 216-8511, Japan

RECRUITING

Yokohama Municipal Citizen's Hospital ( Site 2824)

Yokohama, Kanagawa, 221-0855, Japan

RECRUITING

Kanagawa Cancer Center ( Site 2820)

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Saiseikai Matsusaka Municipal Hospital ( Site 2808)

Matsusaka, Mie-ken, 515-8544, Japan

RECRUITING

Tohoku University Hospital ( Site 2804)

Sendai, Miyagi, 980-8574, Japan

RECRUITING

Kansai Medical University Hospital ( Site 2809)

Hirakata, Osaka, 573-1191, Japan

RECRUITING

National Hospital Organization Kinki-chuo Chest Medical Center ( Site 2822)

Sakai, Osaka, 591-8555, Japan

RECRUITING

Osaka Medical and Pharmaceutical University Hospital ( Site 2810)

Takatsuki, Osaka, 569-8686, Japan

RECRUITING

National Hospital Organization Ureshino Medical Center ( Site 2817)

Ureshino, Saga-ken, 843-0393, Japan

RECRUITING

Nippon Medical School Hospital ( Site 2819)

Bunkyo, Tokyo, 113-8603, Japan

RECRUITING

Tokyo Metropolitan Komagome Hospital ( Site 2823)

Bunkyo, Tokyo, 113-8677, Japan

RECRUITING

Tokyo Medical University Hospital ( Site 2829)

Shinjuku, Tokyo, 160-0023, Japan

RECRUITING

National Center for Global Health and Medicine ( Site 2806)

Shinjuku, Tokyo, 162-8655, Japan

RECRUITING

Chiba University Hospital ( Site 2812)

Chiba, 260-8677, Japan

RECRUITING

National Hospital Organization Kyushu Medical Center ( Site 2801)

Fukuoka, 810-8563, Japan

RECRUITING

Hiroshima City Hiroshima Citizens Hospital ( Site 2821)

Hiroshima, 730-8518, Japan

RECRUITING

Saiseikai Kumamoto Hospital ( Site 2816)

Kumamoto, 861-4193, Japan

RECRUITING

Osaka Metropolitan University Hospital ( Site 2826)

Osaka, 545-8586, Japan

RECRUITING

Sultan Ismail Hospital ( Site 3103)

Johor Bahru, Johor, 81100, Malaysia

RECRUITING

University Malaya Medical Centre ( Site 3107)

Wilayah Persekutuan, Kuala Lumpur, 59100, Malaysia

RECRUITING

Hospital Tengku Ampuan Afzan ( Site 3109)

Kuantan, Pahang, 25100, Malaysia

RECRUITING

Hospital Pulau Pinang ( Site 3108)

George Town, Pulau Pinang, 10990, Malaysia

RECRUITING

Hospital Wanita and Kanak Kanak Sabah ( Site 3110)

Kota Kinabalu, Sabah, 88996, Malaysia

RECRUITING

Sarawak General Hospital ( Site 3101)

Kuching, Sarawak, 93586, Malaysia

RECRUITING

Sunway Medical Centre ( Site 3106)

Petaling Jaya, Selangor, 47500, Malaysia

RECRUITING

Cengild G.I. Medical Centre ( Site 3112)

Kuala Lumpur, 592000, Malaysia

RECRUITING

CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV ( Site 0801)

Guadalajara, Jalisco, 44260, Mexico

RECRUITING

Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0800)

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Scientia Investigacion Clinica S.C. ( Site 0804)

Chihuahua City, 31207, Mexico

RECRUITING

Grupo Médico ASSET ( Site 0811)

Mexico City, 3100, Mexico

RECRUITING

Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1907)

Breda, North Brabant, 4818 CK, Netherlands

RECRUITING

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0902)

Lima, 15036, Peru

RECRUITING

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2008)

Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

RECRUITING

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2012)

Gliwice, Silesian Voivodeship, 44-102, Poland

RECRUITING

Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 2004)

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

RECRUITING

Spitalul Clinic Colțea ( Site 2102)

Bucharest, Bucharest, 030171, Romania

RECRUITING

Institutul Oncologic Prof. Dr. I Chiricuta ( Site 2103)

Cluj-Napoca, Cluj, 400015, Romania

RECRUITING

SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2101)

Florești, Cluj, 407280, Romania

RECRUITING

Centrul de Oncologie "Sfântul Nectarie" ( Site 2107)

Craiova, Dolj, 200347, Romania

RECRUITING

Spitalul Municipal Schuller Ploiești ( Site 2106)

Ploieşti, Prahova, 100337, Romania

RECRUITING

SC ONCO CARD SRL ( Site 2109)

Brasov, 500052, Romania

RECRUITING

SC MNT Healthcare Europe SRL ( Site 2105)

Bucharest, 013975, Romania

RECRUITING

Delta Health Care SRL ( Site 2108)

Bucharest, 014142, Romania

RECRUITING

Chonnam National University Hwasun Hospital ( Site 3502)

Jeollanam-do, Jeonranamdo, 58128, South Korea

RECRUITING

Pusan National University Yangsan Hospital ( Site 3504)

Yangsan, Kyongsangnam-do, 50612, South Korea

RECRUITING

Pusan National University Hospital ( Site 3501)

Busan, Pusan-Kwangyokshi, 49241, South Korea

RECRUITING

Chungnam National University Hospital ( Site 3503)

Daejeon, Taejon-Kwangyokshi, 35015, South Korea

RECRUITING

Kyung Hee University Medical Center ( Site 3500)

Seoul, 02447, South Korea

RECRUITING

Korea University Guro Hospital ( Site 3505)

Seoul, 08308, South Korea

RECRUITING

Institut Català d'Oncologia (ICO) - Badalona ( Site 2200)

Badalona, Catalonia, 08916, Spain

RECRUITING

HOSPITAL CLÍNIC DE BARCELONA ( Site 2201)

Barcelona, Catalonia, 08036, Spain

RECRUITING

Complejo Hospitalario Universitario A Coruna ( Site 2207)

A Coruña, La Coruna, 15006, Spain

RECRUITING

HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 2202)

Majadahonda, Madrid, Comunidad de, 28220, Spain

RECRUITING

Hospital General Universitario de Valencia ( Site 2204)

Valencia, Valenciana, Comunitat, 46014, Spain

RECRUITING

Hospital Universitario Ramon y Cajal ( Site 2203)

Madrid, 28034, Spain

RECRUITING

Hospital Universitario Virgen de Valme ( Site 2205)

Seville, 41014, Spain

RECRUITING

Chang Gung Memorial Hospital- Chiayi ( Site 3611)

Chiayi City, Chiayi, 613, Taiwan

RECRUITING

Taipei Medical University Shuang Ho Hospital ( Site 3602)

New Taipei City, 235, Taiwan

RECRUITING

National Cheng Kung University Hospital ( Site 3604)

Tainan, 704, Taiwan

RECRUITING

MacKay Memorial Hospital ( Site 3609)

Taipei, 10449, Taiwan

RECRUITING

National Taiwan University Cancer Center (NTUCC) ( Site 3601)

Taipei, 106, Taiwan

RECRUITING

Tri-Service General Hospital ( Site 3603)

Taipei, 114, Taiwan

RECRUITING

Hacettepe Universite Hastaneleri ( Site 2400)

Altindağ, Ankara, 06230, Turkey (Türkiye)

RECRUITING

Trakya Universitesi Tip Fakultesi ( Site 2406)

Edirne, 22030, Turkey (Türkiye)

RECRUITING

Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 2504)

Chernivtsi, Chernivetska Oblast, 58013, Ukraine

RECRUITING

Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical ( Site 2507)

Lviv, Lviv Oblast, 79031, Ukraine

RECRUITING

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2517)

Rivne, Rivne Oblast, 33010, Ukraine

RECRUITING

Zhytomyr Regional Oncology Center ( Site 2519)

Zhytomyr, Zhytomyr Oblast, 10002, Ukraine

RECRUITING

Shalimov Institute of Surgery and Transplantation Oncology department ( Site 2512)

Kyiv, 02000, Ukraine

RECRUITING

Universal Clinic Oberig ( Site 2506)

Kyiv, 03057, Ukraine

RECRUITING

Royal Cornwall Hospital ( Site 2614)

Truro, Cornwall, TR1 2LJ, United Kingdom

RECRUITING

Royal Free Hospital ( Site 2601)

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

RECRUITING

Leicester Royal Infirmary ( Site 2610)

Leicester, LE1 5WW, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; Pemetrexed; Cisplatin; Carboplatin

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)

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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 24, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): December 7, 2029
• Study Completion (Estimated): August 6, 2032
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

BE (1); NL (1); CN (29); GU (3); KR (6); IT (11); GB (3); PE (1); TW (6); TU (2); BR (9); ME (4); JP (27); CL (3); RO (8); FR (7); HU (2); US (9); IL (5); GR (5); PL (3); AR (4); ES (7); UA (6); MY (8); CO (3); AU (4); CA (1)