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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)
Sponsor: Merck Sharp & Dohme LLC
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 is one primary study hypothesis: 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).
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
348
Start Date
2024-05-24
Completion Date
2031-02-18
Last Updated
2026-10-26
Healthy Volunteers
No
Conditions
Interventions
Calderasib
Oral tablets
Placebo
Oral tablets
Pembrolizumab
IV infusion
Locations (246)
CBCC Global Research, Inc. ( Site 0123)
Bakersfield, California, United States
Beverly Hills Cancer Center ( Site 0116)
Beverly Hills, California, United States
Stamford Hospital ( Site 0136)
Stamford, Connecticut, United States
Mount Sinai Cancer Center ( Site 0137)
Miami Beach, Florida, United States
Orchard Healthcare Research Inc. ( Site 0115)
Skokie, Illinois, United States
Truman Medical Center ( Site 0126)
Kansas City, Missouri, United States
Cox Medical Center North ( Site 0133)
Springfield, Missouri, United States
St. Vincent Frontier Cancer Center-Research ( Site 0105)
Billings, Montana, United States
Atlantic Health System Morristown Medical Center ( Site 0121)
Morristown, New Jersey, United States
New York Oncology Hematology, P.C. ( Site 0132)
Albany, New York, United States
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103)
Cincinnati, Ohio, United States
Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106)
Kettering, Ohio, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0134)
Lancaster, Pennsylvania, United States
Oncology Consultants P.A. ( Site 0113)
Houston, Texas, United States
Circuit Clinical/SSM Health Dean Medical Group ( Site 0129)
Madison, Wisconsin, United States
Centro de Oncología e Investigación de Buenos Aires ( Site 0308)
Berazategui, Buenos Aires, Argentina
AUSTRAL MEDICAL CENTER ( Site 0302)
CABA, Buenos Aires, Argentina
Centro Oncologico Korben ( Site 0304)
CABA, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
Mar del Plata, Buenos Aires, Argentina
Clinica Viedma S. A ( Site 0307)
Viedma, Río Negro Province, Argentina
Fundacion Estudios Clinicos ( Site 0306)
Rosario, Santa Fe Province, Argentina
Sanatorio Parque ( Site 0301)
Rosario, Santa Fe Province, Argentina
Chris O'Brien Lifehouse ( Site 3000)
Camperdown, New South Wales, Australia
Cancer Care Service Hervey Bay ( Site 3003)
Urraween, Queensland, Australia
Frankston Hospital ( Site 3002)
Frankston, Victoria, Australia
One Clinical Research ( Site 3001)
Nedlands, Western Australia, Australia
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 2401)
Graz, Styria, Austria
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2400)
Vienna, Austria
Hospital Mario Penna ( Site 0436)
Belo Horizonte, Minas Gerais, Brazil
Hospital de Câncer de Recife ( Site 0447)
Recife, Pernambuco, Brazil
Oncoclínica Oncologistas Associados ( Site 0441)
Teresina, Piauí, Brazil
Liga Norte Riograndense Contra o Câncer ( Site 0439)
Natal, Rio Grande do Norte, Brazil
Hospital de Caridade de Ijuí ( Site 0438)
Ijuí, Rio Grande do Sul, Brazil
Hospital de Clínicas de Passo Fundo ( Site 0442)
Passo Fundo, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro Multidisciplinar de Pesquisa Clínica ( Site 0435)
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0437)
Barretos, São Paulo, Brazil
Instituto Nacional de Câncer - INCA ( Site 0446)
Rio de Janeiro, Brazil
Americas ( Site 0431)
Rio de Janeiro, Brazil
MBAL Uni Hospital-Department of Medical Oncology ( Site 1000)
Panagyurishte, Pazardzhik, Bulgaria
Multiprofile Hospital for Active Treatment SerdikaМЕD EOOD-Second Department of Medical Oncology ( Site 1002)
Sofia, Sofia (stolitsa), Bulgaria
MHAT - Heart and Brain ( Site 1006)
Pleven, Bulgaria
Medical Center Futuremeds ( Site 1007)
Plovdiv, Bulgaria
Complex Oncology Center - Plovdiv EOOD ( Site 1003)
Plovdiv, Bulgaria
CancerCare Manitoba ( Site 0210)
Winnipeg, Manitoba, Canada
QEII Health Sciences Centre - Victoria General Site-Dept. of Medical Oncology ( Site 0208)
Halifax, Nova Scotia, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0205)
Hamilton, Ontario, Canada
Sunnybrook Research Institute ( Site 0206)
Toronto, Ontario, Canada
St. Marys Hospital Center ( Site 0204)
Montreal, Quebec, Canada
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0207)
Trois-Rivières, Quebec, Canada
Clinica Universidad Catolica del Maule-Oncology ( Site 0500)
Talca, Maule Region, Chile
Orlandi Oncologia-Oncology ( Site 0503)
Santiago, Region M. de Santiago, Chile
FALP-UIDO ( Site 0501)
Santiago, Region M. de Santiago, Chile
Centro de Oncología de Precisión ( Site 0502)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 0504)
Santiago, Region M. de Santiago, Chile
Anhui Provincial Cancer Hospital ( Site 3136)
Hefei, Anhui, China
Beijing Cancer hospital ( Site 3133)
Beijing, Beijing Municipality, China
Beijing Cancer hospital ( Site 3134)
Beijing, Beijing Municipality, China
Beijing Peking Union Medical College Hospital-pneumology department ( Site 3102)
Beijing, Beijing Municipality, China
Beijing Chest Hospital,Capital Medical University ( Site 3104)
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital ( Site 3119)
Chongqing, Chongqing Municipality, China
Army Medical Center of People's Liberation Army ( Site 3142)
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital ( Site 3127)
Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University ( Site 3148)
Xiamen, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University ( Site 3108)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 3128)
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center ( Site 3137)
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital ( Site 3123)
Harbin, Heilongjiang, China
JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 3124)
Jiamusi, Heilongjiang, China
Henan Cancer Hospital ( Site 3149)
Zhengzhou, Henan, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 3113)
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 3126)
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University ( Site 3130)
Changsha, Hunan, China
Hunan Cancer Hospital ( Site 3141)
Changsha, Hunan, China
Nanjing Gulou Hospital ( Site 3122)
Nanjing, Jiangsu, China
Nanjing First Hospital ( Site 3154)
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University ( Site 3146)
Suzhou, Jiangsu, China
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3155)
Wuxi, Jiangsu, China
The Second Affiliated Hospital of Nanchang University ( Site 3139)
Nanchang, Jiangxi, China
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3138)
Nanchang, Jiangxi, China
Jilin Province Tumor Hospital ( Site 3107)
Changchun, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 3150)
Xi'an, Shaanxi, China
Shandong Cancer Hospital ( Site 3116)
Jinan, Shandong, China
LinYi Cancer Hospital ( Site 3111)
Linyi, Shandong, China
Shanghai Chest Hospital ( Site 3100)
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center ( Site 3144)
Shanghai, Shanghai Municipality, China
Zhongshan Hospital,Fudan University ( Site 3143)
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital ( Site 3131)
Taiyuan, Shanxi, China
The Second Affiliated Hospital of Air Force Medical University ( Site 3117)
Xian, Shanxi, China
The Second Affiliated Hospital of Air Force Medical University ( Site 3152)
Xian, Shanxi, China
West China Hospital, Sichuan University ( Site 3140)
Chengdu, Sichuan, China
The Third People's Hospital of Chengdu (CDTPH) ( Site 3157)
Chengdu, Sichuan, China
Sichuan Cancer hospital. ( Site 3109)
Chengdu, Sichuan, China
The Second People's Hospital of Neijiang ( Site 3105)
Neijiang, Sichuan, China
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 3101)
Ürümqi, Xinjiang, China
Yunnan Province Cancer Hospital ( Site 3153)
Kunming, Yunnan, China
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115)
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3121)
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province ( Site 3145)
Linhai, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 3151)
Wenzhou, Zhejiang, China
Sociedad De Oncología y Hematología Del Cesar SAS ( Site 4000)
Valledupar, Cesar Department, Colombia