A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
Start Date
10/8/2025
Completion Date
8/6/2032
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Calderasib
Pembrolizumab (+) Berahyaluronidase alfa
Pemetrexed
Cisplatin
Carboplatin
Conditions
Locations
Central Alabama Research ( Site 0108)
Birmingham, Alabama 35209
United States
University of Connecticut Health Center ( Site 0130)
Farmington, Connecticut 06030-8010
United States
Stamford Hospital ( Site 0126)
Stamford, Connecticut 06902
United States
Mount Sinai Cancer Center ( Site 0137)
Miami Beach, Florida 33140
United States
Indiana University Health Arnett Cancer Center ( Site 0116)
Lafayette, Indiana 47904
United States
New England Cancer Specialists ( Site 0139)
Westbrook, Maine 04092
United States
New York Oncology Hematology, P.C. ( Site 0119)
Albany, New York 12206
United States
St. Charles Health System, Inc ( Site 0146)
Bend, Oregon 97701
United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)
Lancaster, Pennsylvania 17601
United States
Blue Ridge Cancer Care ( Site 0144)
Roanoke, Virginia 24014
United States
Instituto Alexander Fleming ( Site 0311)
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ
Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300)
Mar del Plata, Buenos Aires B7600FZO
Argentina
Hospital Italiano de Cordoba ( Site 0308)
Córdoba, 5000
Argentina
CEMAIC ( Site 0309)
Córdoba, X5008AAC
Argentina
Genesis Care- Campbelltown ( Site 2907)
Campbelltown, New South Wales 2560
Australia
Northern Beaches Hospital ( Site 2905)
Frenchs Forest, New South Wales 2086
Australia
The Prince Charles Hospital ( Site 2903)
Brisbane, Queensland 4032
Australia
Mater Hospital Brisbane ( Site 2906)
South Brisbane, Queensland 4101
Australia
Peninsula & South Eastern Haematology and Oncology Group ( Site 2908)
Frankston, Victoria 3199
Australia
Klinikum Klagenfurt am Wörthersee ( Site 1002)
Klagenfurt, Carinthia 9020
Austria
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1005)
Graz, Styria 8036
Austria
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1001)
Vienna, 1210
Austria
Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3903)
Genk, Limburg 3600
Belgium
VITAZ ( Site 3902)
Sint-Niklaas, Oost-Vlaanderen 9100
Belgium
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0412)
Fortaleza, Ceará 60336-232
Brazil
Hospital Santa Rita de Cassia ( Site 0403)
Vitória, Espírito Santo 29043-260
Brazil
Real Hospital Portugues ( Site 0418)
Recife, Pernambuco 52010075
Brazil
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa ( Site 0400)
Porto Alegre, Rio Grande do Sul 90110-270
Brazil
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0410)
Florianópolis, Santa Catarina 88020-210
Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto USP ( Site 0419)
Ribeirão Preto, São Paulo 14048-900
Brazil
Faculdade de Medicina do ABC ( Site 0411)
Santo André, São Paulo 09060-870
Brazil
Hospital Alemao Oswaldo Cruz ( Site 0413)
São Paulo, São Paulo 01327-001
Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0417)
São Paulo, 04014-002
Brazil
Cross Cancer Institute ( Site 0203)
Edmonton, Alberta T6G 1Z2
Canada
Centro de Estudios Clínicos SAGA ( Site 0503)
Santiago, Region M. de Santiago 7500653
Chile
FALP ( Site 0500)
Santiago, Region M. de Santiago 7500921
Chile
Bradfordhill ( Site 0501)
Santiago, Region M. de Santiago 8420383
Chile
Anhui Provincial Cancer Hospital ( Site 2708)
Hefei, Anhui 230031
China
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2700)
Beijing, Beijing Municipality 100142
China
Beijing Peking Union Medical College Hospital ( Site 2702)
Beijing, Beijing Municipality 100730
China
The First Affiliated Hospital of Fujian Medical University ( Site 2701)
Fujian, Fujian 350005
China
Fujian Provincial Cancer Hospital ( Site 2706)
Fuzhou, Fujian 350014
China
The First Affiliated Hospital of Xiamen University ( Site 2717)
Fuzhou, Fujian 361003
China
The First Affiliated Hospital.Sun Yat-sen University ( Site 2714)
Guangzhou, Guangdong 510080
China
AFFILIATED CANCER HOSPITAL AND INSTITUTE OF GUANGZHOU MEDICAL UNIVERSITY ( Site 2743)
Guangzhou, Guangdong 510095
China
Zhujiang Hospital of Southern Medical University ( Site 2744)
Guangzhou, Guangdong 510280
China
Affiliated Cancer Hospital of Guangxi Medical University ( Site 2704)
Nanning, Guangxi 530021
China
JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 2745)
Jiamusi, Heilongjiang 154007
China
Henan Cancer Hospital ( Site 2746)
Zhengzhou, Henan 450008
China
Tongji Hospital Tongji Medical,Science & Technology ( Site 2722)
Wuhan, Hubei 430030
China
Hubei Cancer Hospital ( Site 2721)
Wuhan, Hubei 430079
China
Xiangya Hospital Central South University ( Site 2741)
Changsha, Hunan 410008
China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 2715)
Nanjing, Jiangsu 210000
China
Jiangxi Cancer Hospital ( Site 2725)
Nanchang, Jiangxi 330029
China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2729)
Xi'an, Shaanxi 710061
China
LinYi Cancer Hospital ( Site 2737)
Linyi, Shandong 276000
China
Shanghai Pulmonary Hospital-Oncology Department ( Site 2723)
Shanghai, Shanghai Municipality 200433
China
Shanxi Cancer Hospital ( Site 2728)
Taiyuan, Shanxi 030013
China
Sichuan Cancer Hospital. ( Site 2739)
Chengdu, Sichuan 610213
China
West China Hospital Sichuan University ( Site 2735)
Chengdu, Sichuan 611135
China
Chongqing University Cancer Hospital ( Site 2736)
Chongqing, Sichuan 400030
China
Yunnan Province Cancer Hospital ( Site 2734)
Kunming, Yunnan 650118
China
The First Affiliated Hospital, Zhejiang University ( Site 2716)
Hangzhou, Zhejiang 310003
China
Sir Run Run Shaw Hospital ( Site 2731)
Hangzhou, Zhejiang 310015
China
Zhejiang Cancer Hospital ( Site 2727)
Hangzhou, Zhejiang 310022
China
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2724)
Taizhou, Zhejiang 317000
China
Instituto De Cancerologia S.A. ( Site 0608)
Medellín, Antioquia 050025
Colombia
Hospital Universitario San Ignacio ( Site 0604)
Bogotá, Bogota D.C. 110231
Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0607)
Bogotá, Bogota D.C. 111321
Colombia
Hopital Europeen Marseille ( Site 1207)
Marseille, Bouches-du-Rhone 13003
France
CHU Caen ( Site 1212)
Caen, Calvados 14000
France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1209)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54500
France
Centre Hospitalier de Pau ( Site 1217)
Pau, Pyrenees-Atlantiques 64000
France
Centre Hospitalier Metropole Savoie Site de Chambery ( Site 1208)
Chambéry, Savoie 73011
France
Clinique de l'Europe ( Site 1213)
Amiens, Somme 80000
France
Groupe Hospitalier Paris Saint Joseph ( Site 1215)
Paris, 75014
France
Hôpital Européen Georges Pompidou ( Site 1214)
Paris, 75015
France
Agios Andreas Hospital Patras ( Site 1407)
Pátrai, Achaia 263 35
Greece
Errikos Dunant Hospital Center ( Site 1408)
Athens, Attica 115 26
Greece
General Hospital of Athens "Laiko" ( Site 1402)
Athens, Attica 11526
Greece
Metropolitan General Hospital ( Site 1400)
Athens, Attica 155 62
Greece
Papageorgiou General Hospital of Thessaloniki ( Site 1403)
Thessaloniki, 564 29
Greece
MEDI-K ( Site 3803)
Guatemala City, 01009
Guatemala
Centro Integral De Oncologia Gastrointestinal Y Hemato-Oncologia De Guatemala, S. A ( Site 3802)
Guatemala City, 01010
Guatemala
Servicios Médicos Oncológicos ( Site 3804)
Guatemala City, 1010
Guatemala
Orszagos Koranyi Pulmonologiai Intezet ( Site 1501)
Budapest, Pest County 1121
Hungary
Reformatus Pulmonologiai Centrum ( Site 1503)
Törökbálint, Pest County 2045
Hungary
Yitzhak Shamir Medical Center. ( Site 1709)
Beer Ya Akov, 7033001
Israel
Shaare Zedek Medical Center ( Site 1706)
Jerusalem, 9103102
Israel
Meir Medical Center. ( Site 1702)
Kfar Saba, 4428164
Israel
Sheba Medical Center ( Site 1700)
Ramat Gan, 5265601
Israel
Sourasky Medical Center ( Site 1705)
Tel Aviv, 6423906
Israel
Azienda Santiaria dell'Alto Adige, comprensorio di Bolzano ( Site 1818)
Bolzano, Bozen 39100
Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807)
Meldola, Forli-Cesena 47014
Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1811)
Bergamo, Lombardy 24127
Italy
Istituto Clinico Humanitas ( Site 1812)
Rozzano, Milano 20089
Italy
Ospedale San Giuseppe Moscati ( Site 1816)
Statte, Taranto 74010
Italy
AOU Careggi ( Site 1801)
Florence, Tuscany 50134
Italy
AOU Renato Dulbecco ( Site 1804)
Catanzaro, 88100
Italy
ASST Grande Ospedale Metropolitano Niguarda ( Site 1817)
Milan, 20162
Italy
A.O.R.N. Antonio Cardarelli ( Site 1810)
Naples, 80131
Italy
Policlinico San Matteo ( Site 1802)
Pavia, 27100
Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 1809)
Verona, 37126
Italy
Aichi Cancer Center ( Site 2813)
Nagoya, Aichi-ken 464-8681
Japan
Fujita Health University Hospital ( Site 2807)
Toyoake, Aichi-ken 470-1192
Japan
Hirosaki University Hospital ( Site 2818)
Hirosaki, Aomori 036-8563
Japan
Ehime University Hospital ( Site 2800)
Tōon, Ehime 791-0295
Japan
Kurume University Hospital ( Site 2815)
Kurume, Fukuoka 830-0011
Japan
Gunma Prefectural Cancer Center ( Site 2802)
Ōta, Gunma 373-8550
Japan
National Hospital Organization Himeji Medical Center ( Site 2827)
Himeji, Hyōgo 670-8520
Japan
Kobe City Medical Center General Hospital ( Site 2811)
Kobe, Hyōgo 650-0047
Japan
Takarazuka City Hospital ( Site 2828)
Takarazuka, Hyōgo 665-0827
Japan
Kanazawa University Hospital ( Site 2805)
Kanazawa, Ishikawa-ken 920-8641
Japan
St. Marianna University Hospital ( Site 2814)
Kawasaki, Kanagawa 216-8511
Japan
Yokohama Municipal Citizen's Hospital ( Site 2824)
Yokohama, Kanagawa 221-0855
Japan
Kanagawa Cancer Center ( Site 2820)
Yokohama, Kanagawa 241-8515
Japan
Saiseikai Matsusaka Municipal Hospital ( Site 2808)
Matsusaka, Mie-ken 515-8544
Japan
Tohoku University Hospital ( Site 2804)
Sendai, Miyagi 980-8574
Japan
Kansai Medical University Hospital ( Site 2809)
Hirakata, Osaka 573-1191
Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 2822)
Sakai, Osaka 591-8555
Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 2810)
Takatsuki, Osaka 569-8686
Japan
National Hospital Organization Ureshino Medical Center ( Site 2817)
Ureshino, Saga-ken 843-0393
Japan
Nippon Medical School Hospital ( Site 2819)
Bunkyo, Tokyo 113-8603
Japan
Tokyo Metropolitan Komagome Hospital ( Site 2823)
Bunkyo, Tokyo 113-8677
Japan
Tokyo Medical University Hospital ( Site 2829)
Shinjuku, Tokyo 160-0023
Japan
National Center for Global Health and Medicine ( Site 2806)
Shinjuku, Tokyo 162-8655
Japan
Chiba University Hospital ( Site 2812)
Chiba, 260-8677
Japan
National Hospital Organization Kyushu Medical Center ( Site 2801)
Fukuoka, 810-8563
Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 2821)
Hiroshima, 730-8518
Japan
Saiseikai Kumamoto Hospital ( Site 2816)
Kumamoto, 861-4193
Japan
Osaka Metropolitan University Hospital ( Site 2826)
Osaka, 545-8586
Japan
Sultan Ismail Hospital ( Site 3103)
Johor Bahru, Johor 81100
Malaysia
University Malaya Medical Centre ( Site 3107)
Wilayah Persekutuan, Kuala Lumpur 59100
Malaysia
Hospital Tengku Ampuan Afzan ( Site 3109)
Kuantan, Pahang 25100
Malaysia
Hospital Pulau Pinang ( Site 3108)
George Town, Pulau Pinang 10990
Malaysia
Hospital Wanita and Kanak Kanak Sabah ( Site 3110)
Kota Kinabalu, Sabah 88996
Malaysia
Sarawak General Hospital ( Site 3101)
Kuching, Sarawak 93586
Malaysia
Sunway Medical Centre ( Site 3106)
Petaling Jaya, Selangor 47500
Malaysia
Cengild G.I. Medical Centre ( Site 3112)
Kuala Lumpur, 592000
Malaysia
CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV ( Site 0801)
Guadalajara, Jalisco 44260
Mexico
Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 0800)
Monterrey, Nuevo León 64460
Mexico
Scientia Investigacion Clinica S.C. ( Site 0804)
Chihuahua City, 31207
Mexico
Grupo Médico ASSET ( Site 0811)
Mexico City, 3100
Mexico
Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1907)
Breda, North Brabant 4818 CK
Netherlands
Elisabeth-TweeSteden Ziekenhuis ( Site 1906)
Tilburg, North Holland 5022 GC
Netherlands
Universitair Medisch Centrum Utrecht ( Site 1901)
Utrecht, 3584 CX
Netherlands
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0902)
Lima, 15036
Peru
Oncosalud ( Site 0901)
Lima, 15036
Peru
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2008)
Przemyśl, Podkarpackie Voivodeship 37-700
Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2012)
Gliwice, Silesian Voivodeship 44-102
Poland
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 2004)
Olsztyn, Warmian-Masurian Voivodeship 10-357
Poland
Spitalul Clinic Colțea ( Site 2102)
Bucharest, Bucharest 030171
Romania
Institutul Oncologic Prof. Dr. I Chiricuta ( Site 2103)
Cluj-Napoca, Cluj 400015
Romania
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2101)
Florești, Cluj 407280
Romania
Centrul de Oncologie "Sfântul Nectarie" ( Site 2107)
Craiova, Dolj 200347
Romania
Spitalul Municipal Schuller Ploiești ( Site 2106)
Ploieşti, Prahova 100337
Romania
SC ONCO CARD SRL ( Site 2109)
Brasov, 500052
Romania
SC MNT Healthcare Europe SRL ( Site 2105)
Bucharest, 013975
Romania
Delta Health Care SRL ( Site 2108)
Bucharest, 014142
Romania
Chonnam National University Hwasun Hospital ( Site 3502)
Jeollanam-do, Jeonranamdo 58128
South Korea
Pusan National University Yangsan Hospital ( Site 3504)
Yangsan, Kyongsangnam-do 50612
South Korea
Pusan National University Hospital ( Site 3501)
Busan, Pusan-Kwangyokshi 49241
South Korea
Chungnam National University Hospital ( Site 3503)
Daejeon, Taejon-Kwangyokshi 35015
South Korea
Kyung Hee University Medical Center ( Site 3500)
Seoul, 02447
South Korea
Korea University Guro Hospital ( Site 3505)
Seoul, 08308
South Korea
Institut Català d'Oncologia (ICO) - Badalona ( Site 2200)
Badalona, Catalonia 08916
Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 2201)
Barcelona, Catalonia 08036
Spain
Complejo Hospitalario Universitario A Coruna ( Site 2207)
A Coruña, La Coruna 15006
Spain
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 2202)
Majadahonda, Madrid, Comunidad de 28220
Spain
Hospital General Universitario de Valencia ( Site 2204)
Valencia, Valenciana, Comunitat 46014
Spain
Hospital Universitario Ramon y Cajal ( Site 2203)
Madrid, 28034
Spain
Hospital Universitario Virgen de Valme ( Site 2205)
Seville, 41014
Spain
Chang Gung Memorial Hospital- Chiayi ( Site 3611)
Chiayi City, Chiayi 613
Taiwan
Taipei Medical University Shuang Ho Hospital ( Site 3602)
New Taipei City, 235
Taiwan
National Cheng Kung University Hospital ( Site 3604)
Tainan, 704
Taiwan
MacKay Memorial Hospital ( Site 3609)
Taipei, 10449
Taiwan
National Taiwan University Cancer Center (NTUCC) ( Site 3601)
Taipei, 106
Taiwan
Tri-Service General Hospital ( Site 3603)
Taipei, 114
Taiwan
Adana Medical Park Seyhan Hastanesi ( Site 2407)
Seyhan, Adana 01140
Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 2400)
Altindağ, Ankara 06230
Turkey (Türkiye)
Gazi Universitesi Tip Fakultesi ( Site 2404)
Ankara, 06560
Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi ( Site 2401)
Ankara, 06800
Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi ( Site 2406)
Edirne, 22030
Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2403)
Istanbul, 34722
Turkey (Türkiye)
Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 2504)
Chernivtsi, Chernivetska Oblast 58013
Ukraine
Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical ( Site 2507)
Lviv, Lviv Oblast 79031
Ukraine
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2518)
Odesa, Odesa Oblast 65025
Ukraine
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2517)
Rivne, Rivne Oblast 33010
Ukraine
Zhytomyr Regional Oncology Center ( Site 2519)
Zhytomyr, Zhytomyr Oblast 10002
Ukraine
Shalimov Institute of Surgery and Transplantation Oncology department ( Site 2512)
Kyiv, 02000
Ukraine
Universal Clinic Oberig ( Site 2506)
Kyiv, 03057
Ukraine
Royal Cornwall Hospital ( Site 2614)
Truro, Cornwall TR1 2LJ
United Kingdom
Royal Free Hospital ( Site 2601)
London, London, City of NW3 2QG
United Kingdom
Queen Elizabeth Hospital Birmingham ( Site 2612)
Birmingham, B15 2TH
United Kingdom
Leicester Royal Infirmary ( Site 2610)
Leicester, LE1 5WW
United Kingdom