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A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
675
Start Date
2025-10-08
Completion Date
2032-08-06
Last Updated
2026-10-26
Healthy Volunteers
No
Conditions
Interventions
Calderasib
Administered as an oral tablet
Pembrolizumab (+) Berahyaluronidase alfa
Administered as a SC injection
Pemetrexed
Administered as an IV Infusion
Cisplatin
Administered as an IV Infusion
Carboplatin
Administered as an IV Infusion
Locations (221)
Central Alabama Research ( Site 0108)
Birmingham, Alabama, United States
University of Connecticut Health Center ( Site 0130)
Farmington, Connecticut, United States
Stamford Hospital ( Site 0126)
Stamford, Connecticut, United States
Mount Sinai Cancer Center ( Site 0137)
Miami Beach, Florida, United States
Low Country Cancer Care ( Site 0156)
Savannah, Georgia, United States
Indiana University Health Arnett Cancer Center ( Site 0116)
Lafayette, Indiana, United States
New England Cancer Specialists ( Site 0139)
Westbrook, Maine, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0152)
Hackensack, New Jersey, United States
New York Oncology Hematology, P.C. ( Site 0119)
Albany, New York, United States
Wilmot Cancer Institute ( Site 0141)
Rochester, New York, United States
St. Charles Health System, Inc ( Site 0146)
Bend, Oregon, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)
Lancaster, Pennsylvania, United States
Hematology Oncology Associates of Fredericksburg ( Site 9550)
Fredericksburg, Virginia, United States
Bon Secours Cancer Institute at St. Francis ( Site 0148)
Midlothian, Virginia, United States
Blue Ridge Cancer Care ( Site 0144)
Roanoke, Virginia, United States
WVU Cancer Institute ( Site 0153)
Morgantown, West Virginia, United States
Instituto Alexander Fleming ( Site 0311)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300)
Mar del Plata, Buenos Aires, Argentina
Hospital Italiano de Cordoba ( Site 0308)
Córdoba, Argentina
CEMAIC ( Site 0309)
Córdoba, Argentina
Genesis Care- Campbelltown ( Site 2907)
Campbelltown, New South Wales, Australia
Northern Beaches Hospital ( Site 2905)
Frenchs Forest, New South Wales, Australia
The Prince Charles Hospital ( Site 2903)
Brisbane, Queensland, Australia
Mater Hospital Brisbane ( Site 2906)
South Brisbane, Queensland, Australia
Peninsula & South Eastern Haematology and Oncology Group ( Site 2908)
Frankston, Victoria, Australia
Klinikum Klagenfurt am Wörthersee ( Site 1002)
Klagenfurt, Carinthia, Austria
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1005)
Graz, Styria, Austria
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1001)
Vienna, Austria
Algemeen Ziekenhuis Klina ( Site 3904)
Brasschaat, Antwerpen, Belgium
Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3903)
Genk, Limburg, Belgium
VITAZ ( Site 3902)
Sint-Niklaas, Oost-Vlaanderen, Belgium
Clinical Chc Montlégia ( Site 3901)
Liège, Belgium
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0412)
Fortaleza, Ceará, Brazil
Hospital Santa Rita de Cassia ( Site 0403)
Vitória, Espírito Santo, Brazil
Real Hospital Portugues ( Site 0418)
Recife, Pernambuco, Brazil
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa ( Site 0400)
Porto Alegre, Rio Grande do Sul, Brazil
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0410)
Florianópolis, Santa Catarina, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto USP ( Site 0419)
Ribeirão Preto, São Paulo, Brazil
Faculdade de Medicina do ABC ( Site 0411)
Santo André, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz ( Site 0413)
São Paulo, São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0417)
São Paulo, Brazil
Cross Cancer Institute ( Site 0203)
Edmonton, Alberta, Canada
Sunnybrook Research Institute ( Site 0209)
Toronto, Ontario, Canada
Centro de Estudios Clínicos SAGA ( Site 0503)
Santiago, Region M. de Santiago, Chile
Fundación Arturo López Pérez ( Site 0500)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0501)
Santiago, Region M. de Santiago, Chile
Anhui Provincial Cancer Hospital ( Site 2708)
Hefei, Anhui, China
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2700)
Beijing, Beijing Municipality, China
Beijing Peking Union Medical College Hospital ( Site 2702)
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University ( Site 2701)
Fujian, Fujian, China
Fujian Provincial Cancer Hospital ( Site 2706)
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 2717)
Fuzhou, Fujian, China
The First Affiliated Hospital.Sun Yat-sen University ( Site 2714)
Guangzhou, Guangdong, China
AFFILIATED CANCER HOSPITAL AND INSTITUTE OF GUANGZHOU MEDICAL UNIVERSITY ( Site 2743)
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University ( Site 2744)
Guangzhou, Guangdong, China
Affiliated Cancer Hospital of Guangxi Medical University ( Site 2704)
Nanning, Guangxi, China
JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 2745)
Jiamusi, Heilongjiang, China
Henan Cancer Hospital ( Site 2746)
Zhengzhou, Henan, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 2722)
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 2721)
Wuhan, Hubei, China
Xiangya Hospital Central South University ( Site 2741)
Changsha, Hunan, China
Hunan Cancer Hospital ( Site 2710)
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 2715)
Nanjing, Jiangsu, China
Jiangxi Cancer Hospital ( Site 2725)
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2729)
Xi'an, Shaanxi, China
LinYi Cancer Hospital ( Site 2737)
Linyi, Shandong, China
Shanghai Chest Hospital ( Site 2747)
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital-Oncology Department ( Site 2723)
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital ( Site 2728)
Taiyuan, Shanxi, China
Sichuan Cancer Hospital. ( Site 2739)
Chengdu, Sichuan, China
West China Hospital Sichuan University ( Site 2735)
Chengdu, Sichuan, China
Chongqing University Cancer Hospital ( Site 2736)
Chongqing, Sichuan, China
Yunnan Province Cancer Hospital ( Site 2734)
Kunming, Yunnan, China
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 2716)
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital ( Site 2731)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 2727)
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2724)
Taizhou, Zhejiang, China
Promotora Médica Las Américas S.A. ( Site 0608)
Medellín, Antioquia, Colombia
Hospital Universitario San Ignacio ( Site 0604)
Bogotá, Bogota D.C., Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0607)
Bogotá, Bogota D.C., Colombia
Hopital Europeen Marseille ( Site 1207)
Marseille, Bouches-du-Rhone, France
CHU Caen ( Site 1212)
Caen, Calvados, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1209)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Centre Hospitalier de Pau ( Site 1217)
Pau, Pyrenees-Atlantiques, France
Centre Hospitalier Metropole Savoie Site de Chambery ( Site 1208)
Chambéry, Savoie, France
Clinique de l'Europe ( Site 1213)
Amiens, Somme, France
Groupe Hospitalier Paris Saint Joseph ( Site 1215)
Paris, France
Hôpital Européen Georges Pompidou ( Site 1214)
Paris, France
Agios Andreas Hospital Patras ( Site 1407)
Pátrai, Achaia, Greece
Errikos Dunant Hospital Center ( Site 1408)
Athens, Attica, Greece
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1409)
Athens, Attica, Greece
General Hospital of Athens "Laiko" ( Site 1402)
Athens, Attica, Greece
Metropolitan General Hospital ( Site 1400)
Athens, Attica, Greece
Papageorgiou General Hospital of Thessaloniki ( Site 1403)
Thessaloniki, Greece
MEDI-K ( Site 3803)
Guatemala City, Guatemala
Centro Integral De Oncologia Gastrointestinal Y Hemato-Oncologia De Guatemala, S. A ( Site 3802)
Guatemala City, Guatemala
Servicios Médicos Oncológicos ( Site 3804)
Guatemala City, Guatemala
Nograd Varmegyei Szent Lazar Korhaz ( Site 1509)
Salgótarján, Nógrád megye, Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 1501)
Budapest, Pest County, Hungary
Reformatus Pulmonologiai Centrum ( Site 1503)
Törökbálint, Pest County, Hungary