RecruitingPhase 3NCT07190248

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

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)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

675 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called calderasib (MK-1084) alone and in combination with other cancer treatments for people with advanced non-small cell lung cancer (NSCLC) that has not been treated with systemic therapy before. **You may be eligible if...** - You have non-squamous NSCLC that is locally advanced (stage IIIB or IIIC, not eligible for surgery or radiation) or metastatic (stage IV) - You have not received prior systemic treatment for your advanced cancer - If HIV positive: your HIV must be well controlled on antiretroviral therapy **You may NOT be eligible if...** - You have small cell lung cancer or mixed tumors with small cell elements - You have active inflammatory bowel disease (like Crohn's disease or ulcerative colitis) - You have uncontrolled heart or blood vessel disease - You have gut absorption problems - You have active brain metastases - You have an active autoimmune disease requiring recent systemic treatment - You have a history of serious lung inflammation (pneumonitis requiring steroids) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCalderasib

Administered as an oral tablet

BIOLOGICALPembrolizumab (+) Berahyaluronidase alfa

Administered as a SC injection

DRUGPemetrexed

Administered as an IV Infusion

DRUGCisplatin

Administered as an IV Infusion

DRUGCarboplatin

Administered as an IV Infusion

Locations(145)

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

Indiana University Health Arnett Cancer Center ( Site 0116)

Lafayette, Indiana, 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

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1001)

Vienna, Austria

Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3903)

Genk, Limburg, 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

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

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

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 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

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

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

Istituto Clinico Humanitas ( Site 1812)

Rozzano, Milano, Italy

Ospedale San Giuseppe Moscati ( Site 1816)

Statte, Taranto, Italy

AOU Careggi ( Site 1801)

Florence, Tuscany, 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

Saiseikai 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

Chiba University Hospital ( Site 2812)

Chiba, 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 Pulau Pinang ( Site 3108)

George Town, Pulau Pinang, Malaysia

Hospital Wanita and Kanak Kanak Sabah ( Site 3110)

Kota Kinabalu, Sabah, Malaysia

Sarawak General Hospital ( Site 3101)

Kuching, Sarawak, Malaysia

Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1907)

Breda, North Brabant, Netherlands

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, Bucharest, 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

Spitalul Municipal Schuller Ploiești ( Site 2106)

Ploieşti, Prahova, Romania

SC ONCO CARD SRL ( Site 2109)

Brasov, Romania

SC MNT Healthcare Europe SRL ( Site 2105)

Bucharest, Romania

Delta Health Care SRL ( Site 2108)

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

Leicester Royal Infirmary ( Site 2610)

Leicester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07190248

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