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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
2026-04-03
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 (116)
Central Alabama Research ( Site 0108)
Birmingham, Alabama, United States
Stamford Hospital ( Site 0126)
Stamford, Connecticut, United States
Mount Sinai Cancer Center ( Site 0137)
Miami Beach, Florida, United States
New England Cancer Specialists ( Site 0139)
Westbrook, Maine, United States
New York Oncology Hematology, P.C. ( Site 0119)
Albany, New York, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)
Lancaster, Pennsylvania, United States
Blue Ridge Cancer Care ( Site 0144)
Roanoke, 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
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1005)
Graz, Styria, Austria
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
IBCC - Núcleo de Pesquisa e Ensino ( Site 0417)
São Paulo, Brazil
Centro de Estudios Clínicos SAGA ( Site 0503)
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
The First Affiliated Hospital of Xiamen University ( Site 2717)
Fuzhou, Fujian, 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
Tongji Hospital Tongji Medical,Science & Technology ( Site 2722)
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 2721)
Wuhan, Hubei, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 2715)
Nanjing, Jiangsu, China
LinYi Cancer Hospital ( Site 2737)
Linyi, Shandong, China
Sichuan Cancer Hospital. ( Site 2739)
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital ( Site 2731)
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2724)
Taizhou, Zhejiang, China
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 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
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
Orszagos Koranyi Pulmonologiai Intezet ( Site 1501)
Budapest, Pest County, Hungary
Reformatus Pulmonologiai Centrum ( Site 1503)
Törökbálint, Pest County, Hungary
Yitzhak Shamir Medical Center. ( Site 1709)
Beer Ya Akov, Israel
Shaare Zedek Medical Center ( Site 1706)
Jerusalem, Israel
Meir Medical Center. ( Site 1702)
Kfar Saba, Israel
Sheba Medical Center ( Site 1700)
Ramat Gan, Israel
Sourasky Medical Center ( Site 1705)
Tel Aviv, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807)
Meldola, Forli-Cesena, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1811)
Bergamo, Lombardy, Italy
AOU Renato Dulbecco ( Site 1804)
Catanzaro, Italy
A.O.R.N. Antonio Cardarelli ( Site 1810)
Naples, Italy
Policlinico San Matteo ( Site 1802)
Pavia, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 1809)
Verona, Italy
Fujita Health University Hospital ( Site 2807)
Toyoake, Aichi-ken, Japan
Hirosaki University Hospital ( Site 2818)
Hirosaki, Aomori, Japan
National Hospital Organization Himeji Medical Center ( Site 2827)
Himeji, Hyōgo, Japan
Kobe City Medical Center General Hospital ( Site 2811)
Kobe, Hyōgo, Japan
Takarazuka City Hospital ( Site 2828)
Takarazuka, Hyōgo, Japan
Yokohama Municipal Citizen's Hospital ( Site 2824)
Yokohama, Kanagawa, Japan
Kanagawa Cancer Center ( Site 2820)
Yokohama, Kanagawa, Japan
Matsusaka Municipal Hospital ( Site 2808)
Matsusaka, Mie-ken, Japan
Tohoku University Hospital ( Site 2804)
Sendai, Miyagi, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 2822)
Sakai, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 2810)
Takatsuki, Osaka, Japan
National Hospital Organization Ureshino Medical Center ( Site 2817)
Ureshino, Saga-ken, Japan
Nippon Medical School Hospital ( Site 2819)
Bunkyo, Tokyo, Japan
Tokyo Medical University Hospital ( Site 2829)
Shinjuku, Tokyo, Japan
National Center for Global Health and Medicine ( Site 2806)
Shinjuku, Tokyo, Japan
National Hospital Organization Kyushu Medical Center ( Site 2801)
Fukuoka, Japan
Saiseikai Kumamoto Hospital ( Site 2816)
Kumamoto, Japan
Osaka Metropolitan University Hospital ( Site 2826)
Osaka, Japan
Hospital Wanita and Kanak Kanak Sabah ( Site 3110)
Kota Kinabalu, Sabah, Malaysia
Sarawak General Hospital ( Site 3101)
Kuching, Sarawak, Malaysia
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2008)
Przemyśl, Podkarpackie Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2012)
Gliwice, Silesian Voivodeship, Poland
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 2004)
Olsztyn, Warmian-Masurian Voivodeship, Poland
Spitalul Clinic Colțea ( Site 2102)
Bucharest, București, Romania
Institutul Oncologic Prof. Dr. I Chiricuta ( Site 2103)
Cluj-Napoca, Cluj, Romania
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2101)
Florești, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie" ( Site 2107)
Craiova, Dolj, Romania
SC ONCO CARD SRL ( Site 2109)
Brasov, Romania
Delta Health Care SRL ( Site 2108)
Bucharest, Romania
SC MNT Healthcare Europe SRL ( Site 2105)
Bucharest, Romania
Chonnam National University Hwasun Hospital ( Site 3502)
Jeollanam-do, Jeonranamdo, South Korea
Pusan National University Yangsan Hospital ( Site 3504)
Yangsan, Kyongsangnam-do, South Korea
Pusan National University Hospital ( Site 3501)
Busan, Pusan-Kwangyokshi, South Korea
Chungnam National University Hospital ( Site 3503)
Daejeon, Taejon-Kwangyokshi, South Korea
Kyung Hee University Medical Center ( Site 3500)
Seoul, South Korea
Korea University Guro Hospital ( Site 3505)
Seoul, South Korea
Institut Català d'Oncologia (ICO) - Badalona ( Site 2200)
Badalona, Catalonia, Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 2201)
Barcelona, Catalonia, Spain
Complejo Hospitalario Universitario A Coruna ( Site 2207)
A Coruña, La Coruna, Spain
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 2202)
Majadahonda, Madrid, Comunidad de, Spain
Hospital General Universitario de Valencia ( Site 2204)
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Ramon y Cajal ( Site 2203)
Madrid, Spain
Hospital Universitario Virgen de Valme ( Site 2205)
Seville, Spain
Chang Gung Memorial Hospital- Chiayi ( Site 3611)
Chiayi City, Chiayi, Taiwan
Taipei Medical University Shuang Ho Hospital ( Site 3602)
New Taipei City, Taiwan
National Cheng Kung University Hospital ( Site 3604)
Tainan, Taiwan
MacKay Memorial Hospital ( Site 3609)
Taipei, Taiwan
Tri-Service General Hospital ( Site 3603)
Taipei, Taiwan
Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 2504)
Chernivtsi, Chernivetska Oblast, Ukraine
Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical ( Site 2507)
Lviv, Lviv Oblast, Ukraine
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2517)
Rivne, Rivne Oblast, Ukraine
Shalimov Institute of Surgery and Transplantation Oncology department ( Site 2512)
Kyiv, Ukraine
Universal Clinic Oberig ( Site 2506)
Kyiv, Ukraine
Royal Cornwall Hospital ( Site 2614)
Truro, Cornwall, United Kingdom
Royal Free Hospital ( Site 2601)
London, London, City of, United Kingdom