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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)
NCT07190248 · Merck Sharp & Dohme LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
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
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
Study design
Enrollment target: 675 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-10-08
Estimated completion: 2032-08-06
Last updated: 2026-04-13
Interventions
Drug: CalderasibBiological: Pembrolizumab (+) Berahyaluronidase alfaDrug: PemetrexedDrug: CisplatinDrug: Carboplatin
Primary outcomes
- • Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% (Up to approximately 48 months)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (122)
Central Alabama Research ( Site 0108)Recruiting
Birmingham, Alabama, United States
Stamford Hospital ( Site 0126)Recruiting
Stamford, Connecticut, United States
Mount Sinai Cancer Center ( Site 0137)Completed
Miami Beach, Florida, United States
New England Cancer Specialists ( Site 0139)Recruiting
Westbrook, Maine, United States
New York Oncology Hematology, P.C. ( Site 0119)Recruiting
Albany, New York, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)Recruiting
Lancaster, Pennsylvania, United States
Blue Ridge Cancer Care ( Site 0144)Recruiting
Roanoke, Virginia, United States
Instituto Alexander Fleming ( Site 0311)Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300)Recruiting
Mar del Plata, Buenos Aires, Argentina
Hospital Italiano de Cordoba ( Site 0308)Recruiting
Córdoba, Argentina
CEMAIC ( Site 0309)Recruiting
Córdoba, Argentina
Genesis Care- Campbelltown ( Site 2907)Recruiting
Campbelltown, New South Wales, Australia
Northern Beaches Hospital ( Site 2905)Recruiting
Frenchs Forest, New South Wales, Australia
The Prince Charles Hospital ( Site 2903)Recruiting
Brisbane, Queensland, Australia
Mater Hospital Brisbane ( Site 2906)Recruiting
South Brisbane, Queensland, Australia
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1005)Recruiting
Graz, Styria, Austria
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa ( Site 0400)Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0410)Recruiting
Florianópolis, Santa Catarina, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto USP ( Site 0419)Recruiting
Ribeirão Preto, São Paulo, Brazil
Faculdade de Medicina do ABC ( Site 0411)Recruiting
Santo André, São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0417)Recruiting
São Paulo, Brazil
Centro de Estudios Clínicos SAGA ( Site 0503)Recruiting
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0501)Recruiting
Santiago, Region M. de Santiago, Chile
Anhui Provincial Cancer Hospital ( Site 2708)Recruiting
Hefei, Anhui, China
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2700)Recruiting
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University ( Site 2701)Recruiting
Fujian, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 2717)Recruiting
Fuzhou, Fujian, China
AFFILIATED CANCER HOSPITAL AND INSTITUTE OF GUANGZHOU MEDICAL UNIVERSITY ( Site 2743)Recruiting
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University ( Site 2744)Recruiting
Guangzhou, Guangdong, China
Affiliated Cancer Hospital of Guangxi Medical University ( Site 2704)Recruiting
Nanning, Guangxi, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 2722)Recruiting
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 2721)Recruiting
Wuhan, Hubei, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 2715)Recruiting
Nanjing, Jiangsu, China
LinYi Cancer Hospital ( Site 2737)Recruiting
Linyi, Shandong, China
Sichuan Cancer Hospital. ( Site 2739)Recruiting
Chengdu, Sichuan, China
Chongqing University Cancer Hospital ( Site 2736)Recruiting
Chongqing, Sichuan, China
Sir Run Run Shaw Hospital ( Site 2731)Recruiting
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2724)Recruiting
Taizhou, Zhejiang, China
Hopital Europeen Marseille ( Site 1207)Recruiting
Marseille, Bouches-du-Rhone, France
CHU Caen ( Site 1212)Recruiting
Caen, Calvados, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1209)Recruiting
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Centre Hospitalier Metropole Savoie Site de Chambery ( Site 1208)Recruiting
Chambéry, Savoie, France
Clinique de l'Europe ( Site 1213)Recruiting
Amiens, Somme, France
Groupe Hospitalier Paris Saint Joseph ( Site 1215)Recruiting
Paris, France
Hôpital Européen Georges Pompidou ( Site 1214)Recruiting
Paris, France
Agios Andreas Hospital Patras ( Site 1407)Recruiting
Pátrai, Achaia, Greece
Errikos Dunant Hospital Center ( Site 1408)Recruiting
Athens, Attica, Greece
General Hospital of Athens "Laiko" ( Site 1402)Recruiting
Athens, Attica, Greece
Metropolitan General Hospital ( Site 1400)Recruiting
Athens, Attica, Greece
Papageorgiou General Hospital of Thessaloniki ( Site 1403)Recruiting
Thessaloniki, Greece
Orszagos Koranyi Pulmonologiai Intezet ( Site 1501)Recruiting
Budapest, Pest County, Hungary
Reformatus Pulmonologiai Centrum ( Site 1503)Recruiting
Törökbálint, Pest County, Hungary
Yitzhak Shamir Medical Center. ( Site 1709)Recruiting
Beer Ya Akov, Israel
Shaare Zedek Medical Center ( Site 1706)Recruiting
Jerusalem, Israel
Meir Medical Center. ( Site 1702)Recruiting
Kfar Saba, Israel
Sheba Medical Center ( Site 1700)Recruiting
Ramat Gan, Israel
Sourasky Medical Center ( Site 1705)Recruiting
Tel Aviv, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807)Recruiting
Meldola, Forli-Cesena, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1811)Recruiting
Bergamo, Lombardy, Italy
Istituto Clinico Humanitas ( Site 1812)Recruiting
Rozzano, Milano, Italy
Ospedale San Giuseppe Moscati ( Site 1816)Recruiting
Statte, Taranto, Italy
AOU Careggi ( Site 1801)Recruiting
Florence, Tuscany, Italy
AOU Renato Dulbecco ( Site 1804)Recruiting
Catanzaro, Italy
A.O.R.N. Antonio Cardarelli ( Site 1810)Recruiting
Naples, Italy
Policlinico San Matteo ( Site 1802)Recruiting
Pavia, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 1809)Recruiting
Verona, Italy
Fujita Health University Hospital ( Site 2807)Recruiting
Toyoake, Aichi-ken, Japan
Hirosaki University Hospital ( Site 2818)Recruiting
Hirosaki, Aomori, Japan
National Hospital Organization Himeji Medical Center ( Site 2827)Recruiting
Himeji, Hyōgo, Japan
Kobe City Medical Center General Hospital ( Site 2811)Recruiting
Kobe, Hyōgo, Japan
Takarazuka City Hospital ( Site 2828)Recruiting
Takarazuka, Hyōgo, Japan
Yokohama Municipal Citizen's Hospital ( Site 2824)Recruiting
Yokohama, Kanagawa, Japan
Kanagawa Cancer Center ( Site 2820)Recruiting
Yokohama, Kanagawa, Japan
Saiseikai Matsusaka Municipal Hospital ( Site 2808)Recruiting
Matsusaka, Mie-ken, Japan
Tohoku University Hospital ( Site 2804)Recruiting
Sendai, Miyagi, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 2822)Recruiting
Sakai, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 2810)Recruiting
Takatsuki, Osaka, Japan
National Hospital Organization Ureshino Medical Center ( Site 2817)Recruiting
Ureshino, Saga-ken, Japan
Nippon Medical School Hospital ( Site 2819)Recruiting
Bunkyo, Tokyo, Japan
Tokyo Medical University Hospital ( Site 2829)Recruiting
Shinjuku, Tokyo, Japan
National Center for Global Health and Medicine ( Site 2806)Recruiting
Shinjuku, Tokyo, Japan
National Hospital Organization Kyushu Medical Center ( Site 2801)Recruiting
Fukuoka, Japan
Saiseikai Kumamoto Hospital ( Site 2816)Recruiting
Kumamoto, Japan
Osaka Metropolitan University Hospital ( Site 2826)Recruiting
Osaka, Japan
Hospital Pulau Pinang ( Site 3108)Recruiting
George Town, Pulau Pinang, Malaysia
Hospital Wanita and Kanak Kanak Sabah ( Site 3110)Recruiting
Kota Kinabalu, Sabah, Malaysia
Sarawak General Hospital ( Site 3101)Recruiting
Kuching, Sarawak, Malaysia
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2008)Recruiting
Przemyśl, Podkarpackie Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2012)Recruiting
Gliwice, Silesian Voivodeship, Poland
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 2004)Recruiting
Olsztyn, Warmian-Masurian Voivodeship, Poland
Spitalul Clinic Colțea ( Site 2102)Recruiting
Bucharest, Bucharest, Romania
Institutul Oncologic Prof. Dr. I Chiricuta ( Site 2103)Recruiting
Cluj-Napoca, Cluj, Romania
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2101)Recruiting
Florești, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie" ( Site 2107)Recruiting
Craiova, Dolj, Romania
SC ONCO CARD SRL ( Site 2109)Recruiting
Brasov, Romania
SC MNT Healthcare Europe SRL ( Site 2105)Recruiting
Bucharest, Romania
Delta Health Care SRL ( Site 2108)Recruiting
Bucharest, Romania
Chonnam National University Hwasun Hospital ( Site 3502)Recruiting
Jeollanam-do, Jeonranamdo, South Korea
Pusan National University Yangsan Hospital ( Site 3504)Recruiting
Yangsan, Kyongsangnam-do, South Korea
Pusan National University Hospital ( Site 3501)Recruiting
Busan, Pusan-Kwangyokshi, South Korea
Chungnam National University Hospital ( Site 3503)Recruiting
Daejeon, Taejon-Kwangyokshi, South Korea
Kyung Hee University Medical Center ( Site 3500)Recruiting
Seoul, South Korea
Korea University Guro Hospital ( Site 3505)Recruiting
Seoul, South Korea
Institut Català d'Oncologia (ICO) - Badalona ( Site 2200)Recruiting
Badalona, Catalonia, Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 2201)Recruiting
Barcelona, Catalonia, Spain
Complejo Hospitalario Universitario A Coruna ( Site 2207)Recruiting
A Coruña, La Coruna, Spain
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 2202)Recruiting
Majadahonda, Madrid, Comunidad de, Spain
Hospital General Universitario de Valencia ( Site 2204)Recruiting
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Ramon y Cajal ( Site 2203)Recruiting
Madrid, Spain
Hospital Universitario Virgen de Valme ( Site 2205)Recruiting
Seville, Spain
Chang Gung Memorial Hospital- Chiayi ( Site 3611)Recruiting
Chiayi City, Chiayi, Taiwan
Taipei Medical University Shuang Ho Hospital ( Site 3602)Recruiting
New Taipei City, Taiwan
National Cheng Kung University Hospital ( Site 3604)Recruiting
Tainan, Taiwan
MacKay Memorial Hospital ( Site 3609)Recruiting
Taipei, Taiwan
Tri-Service General Hospital ( Site 3603)Recruiting
Taipei, Taiwan
Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 2504)Recruiting
Chernivtsi, Chernivetska Oblast, Ukraine
Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical ( Site 2507)Recruiting
Lviv, Lviv Oblast, Ukraine
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2517)Recruiting
Rivne, Rivne Oblast, Ukraine
Shalimov Institute of Surgery and Transplantation Oncology department ( Site 2512)Recruiting
Kyiv, Ukraine
Universal Clinic Oberig ( Site 2506)Recruiting
Kyiv, Ukraine
Royal Cornwall Hospital ( Site 2614)Recruiting
Truro, Cornwall, United Kingdom
Royal Free Hospital ( Site 2601)Recruiting
London, London, City of, United Kingdom