A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)
7 other identifiers
interventional
600
26 countries
223
Brief Summary
This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses: Hypothesis 1: Combination of calderasib and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Hypothesis 2: Combination of calderasib plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer
Started May 2024
Typical duration for phase_3 nonsmall-cell-lung-cancer
223 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2024
CompletedFirst Posted
Study publicly available on registry
April 3, 2024
CompletedStudy Start
First participant enrolled
May 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 18, 2031
June 8, 2026
June 1, 2026
4.7 years
March 28, 2024
June 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS)
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 42 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Up to approximately 56 months
Secondary Outcomes (16)
Objective Response Rate (ORR)
Up to approximately 42 months
Duration of Response (DOR)
Up to approximately 42 months
Number of Participants Who Experience One or More Adverse Event (AEs)
Up to approximately 56 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Up to approximately 56 months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Baseline and Up to approximately 24 months
- +11 more secondary outcomes
Study Arms (2)
Calderasib with Pembrolizumab
EXPERIMENTALParticipants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and calderasib by oral tablets until discontinuation criterion is met.
Placebo with Pembrolizumab
ACTIVE COMPARATORParticipants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and placebo by oral tablets once daily until discontinuation criterion is met.
Interventions
IV infusion
Eligibility Criteria
You may not qualify if:
- Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
- Provides an archival tumor tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, PD-L1 status, and biomarker research
- If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to \< Grade 1 or baseline
- If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)
- If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable
- Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
- Has known history of, or active, neurologic paraneoplastic syndrome
- Has an active infection requiring systemic therapy, with exceptions
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has one or more of the following ophthalmological findings/conditions: intraocular pressure \>21 mmHg and/or any diagnosis of glaucoma, diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative disease
- Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC
- Has received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (225)
CBCC Global Research, Inc. ( Site 0123)
Bakersfield, California, 93309, United States
Beverly Hills Cancer Center ( Site 0116)
Beverly Hills, California, 90211, United States
Stamford Hospital ( Site 0136)
Stamford, Connecticut, 06902, United States
Mount Sinai Cancer Center ( Site 0137)
Miami Beach, Florida, 33140, United States
Orchard Healthcare Research Inc. ( Site 0115)
Skokie, Illinois, 60077, United States
Truman Medical Center ( Site 0126)
Kansas City, Missouri, 64108, United States
Cox Medical Center North ( Site 0133)
Springfield, Missouri, 65807, United States
St. Vincent Frontier Cancer Center-Research ( Site 0105)
Billings, Montana, 59102, United States
Atlantic Health System Morristown Medical Center ( Site 0121)
Morristown, New Jersey, 07960, United States
New York Oncology Hematology, P.C. ( Site 0132)
Albany, New York, 12206, United States
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103)
Cincinnati, Ohio, 45219, United States
Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106)
Kettering, Ohio, 45429, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0134)
Lancaster, Pennsylvania, 17601, United States
Oncology Consultants P.A. ( Site 0113)
Houston, Texas, 77030, United States
Circuit Clinical/SSM Health Dean Medical Group ( Site 0129)
Madison, Wisconsin, 53715, United States
AUSTRAL MEDICAL CENTER ( Site 0302)
CABA, Buenos Aires, C1019ABS, Argentina
Centro Oncologico Korben ( Site 0304)
CABA, Buenos Aires, C1426AGE, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
Mar del Plata, Buenos Aires, B7600FZO, Argentina
Fundacion Estudios Clinicos ( Site 0306)
Rosario, Santa Fe Province, S2000DEJ, Argentina
Sanatorio Parque ( Site 0301)
Rosario, Santa Fe Province, S2000DSV, Argentina
Chris O'Brien Lifehouse ( Site 3000)
Camperdown, New South Wales, 2050, Australia
Cancer Care Service Hervey Bay ( Site 3003)
Urraween, Queensland, 4655, Australia
Frankston Hospital ( Site 3002)
Frankston, Victoria, 3199, Australia
One Clinical Research ( Site 3001)
Nedlands, Western Australia, 6009, Australia
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 2401)
Graz, Styria, 8036, Austria
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2400)
Vienna, 1210, Austria
Hospital Mario Penna ( Site 0436)
Belo Horizonte, Minas Gerais, 30380-472, Brazil
Hospital de Câncer de Recife ( Site 0447)
Recife, Pernambuco, 50040-000, Brazil
Oncoclínica Oncologistas Associados ( Site 0441)
Teresina, Piauí, 64049-200, Brazil
Liga Norte Riograndense Contra o Câncer ( Site 0439)
Natal, Rio Grande do Norte, 59062-000, Brazil
Hospital de Caridade de Ijuí ( Site 0438)
Ijuí, Rio Grande do Sul, 98700 000, Brazil
Hospital de Clínicas de Passo Fundo ( Site 0442)
Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro Multidisciplinar de Pesquisa Clínica ( Site 0435)
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0437)
Barretos, São Paulo, 14784-400, Brazil
Instituto Nacional de Câncer - INCA ( Site 0446)
Rio de Janeiro, 20230-130, Brazil
Americas ( Site 0431)
Rio de Janeiro, 22775-001, Brazil
MBAL Uni Hospital-Department of Medical Oncology ( Site 1000)
Panagyurishte, Pazardzhik, 4500, Bulgaria
Multiprofile Hospital for Active Treatment SerdikaМЕD EOOD-Second Department of Medical Oncology ( Site 1002)
Sofia, Sofia (stolitsa), 1632, Bulgaria
MHAT - Heart and Brain ( Site 1006)
Pleven, 5804, Bulgaria
Medical Center Futuremeds ( Site 1007)
Plovdiv, 4000, Bulgaria
Complex Oncology Center - Plovdiv EOOD ( Site 1003)
Plovdiv, 4004, Bulgaria
CancerCare Manitoba ( Site 0210)
Winnipeg, Manitoba, R3E 0V9, Canada
QEII Health Sciences Centre - Victoria General Site-Dept. of Medical Oncology ( Site 0208)
Halifax, Nova Scotia, B3H 2Y9, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0205)
Hamilton, Ontario, L8V 5C2, Canada
Sunnybrook Research Institute ( Site 0206)
Toronto, Ontario, M4N 3M5, Canada
St. Marys Hospital Center ( Site 0204)
Montreal, Quebec, H3T 1M5, Canada
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0207)
Trois-Rivières, Quebec, G8Z 3R9, Canada
Clinica Universidad Catolica del Maule-Oncology ( Site 0500)
Talca, Maule Region, 3465584, Chile
Orlandi Oncologia-Oncology ( Site 0503)
Santiago, Region M. de Santiago, 7500713, Chile
FALP-UIDO ( Site 0501)
Santiago, Region M. de Santiago, 7500921, Chile
Centro de Oncología de Precisión-Oncology ( Site 0502)
Santiago, Region M. de Santiago, 7560908, Chile
Bradfordhill-Clinical Area ( Site 0504)
Santiago, Region M. de Santiago, 8420383, Chile
Anhui Provincial Cancer Hospital ( Site 3136)
Hefei, Anhui, 230031, China
Beijing Cancer hospital ( Site 3133)
Beijing, Beijing Municipality, 100142, China
Beijing Cancer hospital ( Site 3134)
Beijing, Beijing Municipality, 100142, China
Beijing Peking Union Medical College Hospital-pneumology department ( Site 3102)
Beijing, Beijing Municipality, 100730, China
Beijing Chest Hospital,Capital Medical University ( Site 3104)
Beijing, Beijing Municipality, 101149, China
Chongqing University Cancer Hospital ( Site 3119)
Chongqing, Chongqing Municipality, 400030, China
Army Medical Center of People's Liberation Army ( Site 3142)
Chongqing, Chongqing Municipality, 400042, China
Fujian Cancer Hospital ( Site 3127)
Fuzhou, Fujian, 350014, China
The First Affiliated hospital of Xiamen University ( Site 3148)
Xiamen, Fujian, 361003, China
The First Affiliated Hospital of Guangzhou Medical University ( Site 3108)
Guangzhou, Guangdong, 510160, China
Southern Medical University Nanfang Hospital ( Site 3128)
Guangzhou, Guangdong, 510515, China
Sun Yat-sen University Cancer Center ( Site 3137)
Guangzhou, Guangdong, 510555, China
Harbin Medical University Cancer Hospital ( Site 3123)
Harbin, Heilongjiang, 150081, China
JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 3124)
Jiamusi, Heilongjiang, 154007, China
Henan Cancer Hospital ( Site 3149)
Zhengzhou, Henan, 450008, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 3113)
Wuhan, Hubei, 430000, China
Hubei Cancer Hospital ( Site 3126)
Wuhan, Hubei, 430079, China
The Second Xiangya Hospital of Central South University ( Site 3130)
Changsha, Hunan, 410011, China
Hunan Cancer Hospital ( Site 3141)
Changsha, Hunan, 410013, China
Nanjing Gulou Hospital ( Site 3122)
Nanjing, Jiangsu, 210008, China
Nanjing First Hospital ( Site 3154)
Nanjing, Jiangsu, 210012, China
The First Affiliated Hospital of Soochow University ( Site 3146)
Suzhou, Jiangsu, 215006, China
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3155)
Wuxi, Jiangsu, 214122, China
The Second Affiliated Hospital of Nanchang University ( Site 3139)
Nanchang, Jiangxi, 330000, China
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3138)
Nanchang, Jiangxi, 330209, China
Jilin Province Tumor Hospital ( Site 3107)
Changchun, Jilin, 130000, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 3150)
Xi'an, Shaanxi, 710000, China
Shandong Cancer Hospital ( Site 3116)
Jinan, Shandong, 250117, China
LinYi Cancer Hospital ( Site 3111)
Linyi, Shandong, 276001, China
Shanghai Chest Hospital ( Site 3100)
Shanghai, Shanghai Municipality, 200030, China
Fudan University Shanghai Cancer Center ( Site 3144)
Shanghai, Shanghai Municipality, 200032, China
Zhongshan Hospital,Fudan University ( Site 3143)
Shanghai, Shanghai Municipality, 200032, China
Shanxi Cancer Hospital ( Site 3131)
Taiyuan, Shanxi, 030000, China
The Second Affiliated Hospital of Air Force Medical University ( Site 3117)
Xian, Shanxi, 710038, China
The Second Affiliated Hospital of Air Force Medical University ( Site 3152)
Xian, Shanxi, 710038, China
West China Hospital, Sichuan University ( Site 3140)
Chengdu, Sichuan, 610000, China
The Third People's Hospital of Chengdu (CDTPH) ( Site 3157)
Chengdu, Sichuan, 610031, China
Sichuan Cancer hospital. ( Site 3109)
Chengdu, Sichuan, 610042, China
The Second People's Hospital of Neijiang ( Site 3105)
Neijiang, Sichuan, 641000, China
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 3101)
Ürümqi, Xinjiang, 830000, China
Yunnan Province Cancer Hospital ( Site 3153)
Kunming, Yunnan, 650107, China
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115)
Hangzhou, Zhejiang, 310006, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3121)
Hangzhou, Zhejiang, 310016, China
Taizhou Hospital of Zhejiang Province ( Site 3145)
Linhai, Zhejiang, 317000, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 3151)
Wenzhou, Zhejiang, 325015, China
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1103)
Dijon, Bourgogne-Franche-Comté, 21000, France
Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire ( Site 1106)
Nîmes, Gard, 30029, France
Clinique Teissier Groupe ( Site 1100)
Valenciennes, Nord, 59304, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1101)
Clermont-Ferrand, Puy-de-Dome, 63003, France
Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1104)
Avignon, Vaucluse, 84000, France
Hôpital Ambroise Paré-Department of Respiratory Diseases and Thoracic Oncology ( Site 1105)
Boulogne-Billancourt, Île-de-France Region, 92100, France
High Technology Hospital Medcenter ( Site 1203)
Batumi, Adjara, 6000, Georgia
Caucasus Medical Centre ( Site 1202)
Tbilisi, Adjara, 0186, Georgia
American Hospital Network LLC ( Site 1208)
Tbilisi, 0102, Georgia
Todua Clinic, LLC ( Site 1204)
Tbilisi, 0112, Georgia
TSMU and Ingorokva High Medical Technology University Clinic LTD ( Site 1201)
Tbilisi, 0144, Georgia
New Hospitals ( Site 1200)
Tbilisi, 0162, Georgia
Cancer Research Centre. Mardaleishvili Medical Centre ( Site 1205)
Tbilisi, 0177, Georgia
Tbilisi Institute of Medicine ( Site 1206)
Tbilisi, 1206, Georgia
Marienhospital Stuttgart ( Site 1302)
Stuttgart, Baden-Wurttemberg, 70199, Germany
Evangelisches Krankenhaus Bielefeld - Johannesstift ( Site 1307)
Bielefeld, North Rhine-Westphalia, 33611, Germany
Krankenhaus Bethanien ( Site 1303)
Solingen, North Rhine-Westphalia, 42699, Germany
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1402)
Pátrai, Achaia, 26504, Greece
Agios Savvas Regional Cancer Hospital-2nd Medical Oncology Department ( Site 1407)
Athens, Attica, 115 22, Greece
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1400)
Athens, Attica, 115 27, Greece
Athens Medical Center ( Site 1406)
Marousi, Attica, 151 25, Greece
University General Hospital of Larissa-Oncology Clinic ( Site 1403)
Larissa, Thessaly, 411 10, Greece
Agios Loukas Clinic ( Site 1404)
Thessaloniki, 552 36, Greece
G. Papanikolaou General Hospital-Pulmonary Clinic of Aristotle University of Thessaloniki ( Site 1405)
Thessaloniki, 570 10, Greece
Sir H. N. Reliance Foundation Hospital and Research Centre ( Site 3201)
Mumbai, Maharashtra, 400004, India
Tata Memorial Hospital ( Site 3205)
Mumbai, Maharashtra, 400012, India
AIIMS New Delhi Dept of Medicine ( Site 3206)
New Delhi, National Capital Territory of Delhi, 110029, India
Indraprastha Apollo Hospitals-APOLLO RESEARCH INNOVATION ( Site 3203)
New Delhi, National Capital Territory of Delhi, 110076, India
Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia clinica sperimentale Toraco-Polmonare ( Site 1607)
Naples, Campania, 80131, Italy
Ospedale Santa Maria delle Croci ( Site 1606)
Ravenna, Emilia-Romagna, 48121, Italy
CRO-IRCCS-Clinical Oncology ( Site 1605)
Aviano, Friuli Venezia Giulia, 33081, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1601)
Rome, Lazio, 00168, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1600)
Milan, Lombardy, 20133, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1604)
Milan, Lombardy, 20141, Italy
A.O.R.N. Ospedale dei Colli - Monaldi V.-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1602)
Naples, Napoli, 80131, Italy
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1609)
Rome, Roma, 00144, Italy
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno-UOC Oncologia Medica Livorno ( Site 1608)
Livorno, Tuscany, 57124, Italy
IOV - Istituto Oncologico Veneto IRCCS UOSD - Unità di ricerca clinica ( Site 1603)
Padova, 35131, Italy
Nagoya University Hospital ( Site 3309)
Nagoya, Aichi-ken, 466-8560, Japan
Fujita Health University Hospital ( Site 3310)
Toyoake, Aichi-ken, 470-1192, Japan
National Cancer Center Hospital East ( Site 3303)
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center ( Site 3315)
Matsuyam, Ehime, 719-0280, Japan
National Hospital Organization Kyushu Cancer Center ( Site 3316)
Fukuoka, Fukuoka, 811-1395, Japan
Kurume University Hospital ( Site 3317)
Kurume, Fukuoka, 830-0011, Japan
Gunma Prefectural Cancer Center ( Site 3302)
Ōta, Gunma, 373-8550, Japan
Sapporo Medical University Hospital ( Site 3324)
Sapporo, Hokkaido, 060-8543, Japan
Kanazawa University Hospital ( Site 3308)
Kanazawa, Ishikawa-ken, 920-8641, Japan
St. Marianna University Hospital ( Site 3320)
Kawasaki, Kanagawa, 216-8511, Japan
Saiseikai Matsusaka Municipal Hospital ( Site 3311)
Matsusaka, Mie-ken, 515-8544, Japan
Miyagi Cancer Center ( Site 3301)
Natori-shi, Miyagi, 981-1293, Japan
Sendai Kousei Hospital ( Site 3300)
Sendai, Miyagi, 981-0914, Japan
Kansai Medical University Hospital ( Site 3312)
Hirakata, Osaka, 573-1191, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 3313)
Takatsuki, Osaka, 569-8686, Japan
Saitama Prefectural Cancer Center ( Site 3304)
Kitaadachi-gun, Saitama, 362-0806, Japan
Nippon Medical School Hospital ( Site 3306)
Bunkyo, Tokyo, 113-8603, Japan
Toho University Omori Medical Center ( Site 3319)
Ōta-ku, Tokyo, 143-8541, Japan
Tokyo Medical University Hospital ( Site 3307)
Shinjuku, Tokyo, 160-0023, Japan
National Center for Global Health and Medicine ( Site 3305)
Shinjuku, Tokyo, 162-8655, Japan
Chiba University Hospital ( Site 3322)
Chiba, 260-8677, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 3314)
Hiroshima, 730-8518, Japan
Saiseikai Kumamoto Hospital ( Site 3318)
Kumamoto, 861-4193, Japan
Niigata University Medical & Dental Hospital ( Site 3323)
Niigata, 951-8520, Japan
Osaka Metropolitan University Hospital ( Site 3321)
Osaka, 545-8586, Japan
Arké SMO S.A. de C.V. ( Site 0602)
Mexico City, Mexico City, 06700, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 0600)
Monterrey, Nuevo León, 66460, Mexico
Oaxaca Site Management Organization S.C. ( Site 0603)
Oaxaca City, 68000, Mexico
Ziekenhuis Gelderse Vallei ( Site 1705)
Ede, Gelderland, 6716 RP, Netherlands
Ziekenhuis St. Jansdal-Poli Longziekten ( Site 1701)
Harderwijk, Gelderland, 3844 DG, Netherlands
Isala, locatie Zwolle-Poli Longziekten ( Site 1700)
Zwolle, Overijssel, 8025 AB, Netherlands
Universitair Medisch Centrum Utrecht ( Site 1704)
Utrecht, 3584 CX, Netherlands
Auckland City Hospital ( Site 3400)
Auckland, 1023, New Zealand
The Medical City ( Site 3507)
Pasig, National Capital Region, 1600, Philippines
Lung Center of the Philippines-Pulmonary, Critical Care and Sleep Medicine ( Site 3503)
Quezon City, National Capital Region, 1100, Philippines
Veterans Memorial Medical Center-Section of Oncology ( Site 3505)
Quezon City, National Capital Region, 1100, Philippines
ST. LUKE'S MEDICAL CENTER-Medical oncology ( Site 3501)
Quezon City, National Capital Region, 1102, Philippines
Szpital Specjalistyczny im. Henryka Klimontowicza ( Site 1801)
Gorlice, Lesser Poland Voivodeship, 38-300, Poland
Pratia MCM Krakow ( Site 1808)
Krakow, Lesser Poland Voivodeship, 30-727, Poland
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie ( Site 1805)
Lublin, Lublin Voivodeship, 20-090, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1800)
Warsaw, Masovian Voivodeship, 02-781, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1804)
Przemyśl, Podkarpackie Voivodeship, 37-700, Poland
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 1809)
Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland
Centrul de Diagnostic si Tratament Provita. ( Site 1992)
Bucharest, Bucharest, 020335, Romania
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1994)
Craiova, Dolj, 200542, Romania
Cabinet Medical Oncomed ( Site 1998)
Timișoara, Timiș County, 300239, Romania
SC ONCO CARD SRL ( Site 1995)
Brasov, 500052, Romania
Institutul Oncologic Cluj-Oncologie Medicala ( Site 1999)
Cluj-Napoca, 400015, Romania
Sigmedical Services SRL ( Site 1997)
Suceava, 720214, Romania
The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3606)
Bupyeong-gu, Incheon, 21431, South Korea
Chonnam National University Hwasun Hospital-Pulmonology ( Site 3604)
Hwasun, Jeonranamdo, 58128, South Korea
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3600)
Suwon, Kyonggi-do, 16247, South Korea
Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3603)
Yangsan, Kyongsangnam-do, 50612, South Korea
Yeungnam University Hospital ( Site 3607)
Daegu, Taegu-Kwangyokshi, 42415, South Korea
Keimyung University Dongsan Hospital ( Site 3611)
Daegu, Taegu-Kwangyokshi, 42601, South Korea
Chungnam national university hospital ( Site 3602)
Junggu, Taejon-Kwangyokshi, 35015, South Korea
Inha University Hospital ( Site 3610)
Incheon, 22332, South Korea
Kyung Hee University Hospital ( Site 3605)
Seoul, 02447, South Korea
Korea University Anam Hospital ( Site 3609)
Seoul, 02841, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3608)
Seoul, 03312, South Korea
Korea University Guro Hospital ( Site 3601)
Seoul, 08308, South Korea
Hospital Insular de Gran Canaria-Oncology ( Site 2019)
Las Palmas de Gran Canaria, Las Palmas, 35001, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2012)
Madrid, Madrid, Comunidad de, 28009, Spain
H.R.U Málaga - Hospital General-Oncology ( Site 2014)
Málaga, Malaga, 29011, Spain
Hospital Universitari Vall d Hebron ( Site 2010)
Barcelona, 08035, Spain
Hospital Universitario La Princesa ( Site 2020)
Madrid, 28006, Spain
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 2017)
Madrid, 28040, Spain
Hospital Universitario Virgen de la Victoria ( Site 2021)
Málaga, 29010, Spain
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2015)
Seville, 41009, Spain
Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2102)
Bornova, İzmir, 35100, Turkey (Türkiye)
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2107)
Adana, 01140, Turkey (Türkiye)
SBU GULHANE EGITIM VE ARASTIRMA HASTANESI Onkoloji ( Site 2104)
Ankara, 06010, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2101)
Ankara, 06230, Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 2106)
Ankara, 06520, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 2100)
Ankara, 06800, Turkey (Türkiye)
Medipol Mega Universite Hastanesi-oncology ( Site 2105)
Istanbul, 34214, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2103)
Istanbul, 34722, Turkey (Türkiye)
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 2209)
Cherkasy, Cherkasy Oblast, 18009, Ukraine
Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2210)
Chernivtsi, Chernivetska Oblast, 58013, Ukraine
Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2215)
Kryvyi Rih, Dnipropetrovsk Oblast, 50000, Ukraine
Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 2202)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine
Kirovohrad Regional Oncology Center-Chemotherapy department ( Site 2204)
Kropyvnytskyi, Kirovohrad Oblast, 25011, Ukraine
Medical Center "MedOffice Group" ( Site 2219)
Kiev, Kyivska Oblast, 03022, Ukraine
Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2217)
Lviv, Lviv Oblast, 79059, Ukraine
Rivne Regional Clinical Hospital ( Site 2205)
Rivne, Rivne Oblast, 33007, Ukraine
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2920)
Rivne, Rivne Oblast, 33010, Ukraine
Communal Noncommercial Enterprise "Podillia Regional Oncolog-Cardiothoracic department ( Site 2211)
Vinnytsia, Vinnytsia Oblast, 21029, Ukraine
ME Volyn Regional Clinical Hospital of the Volyn Regional Council ( Site 2216)
Lutsk, Volyn Oblast, 43018, Ukraine
Milton Keynes Hospital ( Site 2304)
Milton Keynes, Buckinghamshire, MK6 5LD, United Kingdom
Royal Devon & Exeter Hospital-Oncology ( Site 2302)
Exeter, Devon, EX2 5DW, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2024
First Posted
April 3, 2024
Study Start
May 24, 2024
Primary Completion (Estimated)
February 19, 2029
Study Completion (Estimated)
February 18, 2031
Last Updated
June 8, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf