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NCT07190248PHASE3Recruiting

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Merck Sharp & Dohme LLC

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

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c * If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements * Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has a gastrointestinal disorder affecting absorption * Is HIV positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has active autoimmune disease that has required systemic treatment in the past 2 years * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy except those specified by protocol * Has history of stem cell/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications

Interventions

DRUG

Calderasib

BIOLOGICAL

Pembrolizumab (+) Berahyaluronidase alfa

DRUG

Pemetrexed

DRUG

Cisplatin

DRUG

Carboplatin

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Conditions

Non-small Cell Lung Cancer

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