NCT07190248From ClinicalTrials.govRecruiting

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)

Non-small Cell Lung Cancer

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Merck Sharp & Dohme LLC
Enrolment target: 675
Started: 8 October 2025
Main results due: 7 December 2029
Study sites: 215
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(215)

Central Alabama Research ( Site 0108)
Birmingham, Alabama, United States
Recruiting
University of Connecticut Health Center ( Site 0130)
Farmington, Connecticut, United States
Recruiting
Stamford Hospital ( Site 0126)
Stamford, Connecticut, United States
Recruiting
Mount Sinai Cancer Center ( Site 0137)
Miami Beach, Florida, United States
Completed
Indiana University Health Arnett Cancer Center ( Site 0116)
Lafayette, Indiana, United States
Recruiting
New England Cancer Specialists ( Site 0139)
Westbrook, Maine, United States
Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0152)
Hackensack, New Jersey, United States
Recruiting
New York Oncology Hematology, P.C. ( Site 0119)
Albany, New York, United States
Recruiting
Wilmot Cancer Institute ( Site 0141)
Rochester, New York, United States
Recruiting
St. Charles Health System, Inc ( Site 0146)
Bend, Oregon, United States
Recruiting
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)
Lancaster, Pennsylvania, United States
Recruiting
Hematology Oncology Associates of Fredericksburg ( Site 9550)
Fredericksburg, Virginia, United States
Recruiting
Blue Ridge Cancer Care ( Site 0144)
Roanoke, Virginia, United States
Recruiting
Instituto Alexander Fleming ( Site 0311)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300)
Mar del Plata, Buenos Aires, Argentina
Recruiting
Hospital Italiano de Cordoba ( Site 0308)
Córdoba, Argentina
Recruiting
CEMAIC ( Site 0309)
Córdoba, Argentina
Recruiting
Genesis Care- Campbelltown ( Site 2907)
Campbelltown, New South Wales, Australia
Recruiting
Northern Beaches Hospital ( Site 2905)
Frenchs Forest, New South Wales, Australia
Recruiting
The Prince Charles Hospital ( Site 2903)
Brisbane, Queensland, Australia
Recruiting
Mater Hospital Brisbane ( Site 2906)
South Brisbane, Queensland, Australia
Recruiting
Peninsula & South Eastern Haematology and Oncology Group ( Site 2908)
Frankston, Victoria, Australia
Recruiting
Klinikum Klagenfurt am Wörthersee ( Site 1002)
Klagenfurt, Carinthia, Austria
Recruiting
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1005)
Graz, Styria, Austria
Recruiting
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1001)
Vienna, Austria
Recruiting
Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3903)
Genk, Limburg, Belgium
Recruiting
VITAZ ( Site 3902)
Sint-Niklaas, Oost-Vlaanderen, Belgium
Recruiting
Clinical Chc Montlégia ( Site 3901)
Liège, Belgium
Recruiting
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0412)
Fortaleza, Ceará, Brazil
Recruiting
Hospital Santa Rita de Cassia ( Site 0403)
Vitória, Espírito Santo, Brazil
Recruiting
Real Hospital Portugues ( Site 0418)
Recife, Pernambuco, Brazil
Recruiting
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa ( Site 0400)
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0410)
Florianópolis, Santa Catarina, Brazil
Recruiting
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto USP ( Site 0419)
Ribeirão Preto, São Paulo, Brazil
Recruiting
Faculdade de Medicina do ABC ( Site 0411)
Santo André, São Paulo, Brazil
Recruiting
Hospital Alemao Oswaldo Cruz ( Site 0413)
São Paulo, São Paulo, Brazil
Recruiting
IBCC - Núcleo de Pesquisa e Ensino ( Site 0417)
São Paulo, Brazil
Recruiting
Cross Cancer Institute ( Site 0203)
Edmonton, Alberta, Canada
Recruiting
Sunnybrook Research Institute ( Site 0209)
Toronto, Ontario, Canada
Recruiting
Centro de Estudios Clínicos SAGA ( Site 0503)
Santiago, Region M. de Santiago, Chile
Recruiting
FALP ( Site 0500)
Santiago, Region M. de Santiago, Chile
Recruiting
Bradfordhill ( Site 0501)
Santiago, Region M. de Santiago, Chile
Recruiting
Anhui Provincial Cancer Hospital ( Site 2708)
Hefei, Anhui, China
Recruiting
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2700)
Beijing, Beijing Municipality, China
Recruiting
Beijing Peking Union Medical College Hospital ( Site 2702)
Beijing, Beijing Municipality, China
Recruiting
The First Affiliated Hospital of Fujian Medical University ( Site 2701)
Fujian, Fujian, China
Recruiting
Fujian Provincial Cancer Hospital ( Site 2706)
Fuzhou, Fujian, China
Recruiting
The First Affiliated Hospital of Xiamen University ( Site 2717)
Fuzhou, Fujian, China
Recruiting
The First Affiliated Hospital.Sun Yat-sen University ( Site 2714)
Guangzhou, Guangdong, China
Recruiting
AFFILIATED CANCER HOSPITAL AND INSTITUTE OF GUANGZHOU MEDICAL UNIVERSITY ( Site 2743)
Guangzhou, Guangdong, China
Recruiting
Zhujiang Hospital of Southern Medical University ( Site 2744)
Guangzhou, Guangdong, China
Recruiting
Affiliated Cancer Hospital of Guangxi Medical University ( Site 2704)
Nanning, Guangxi, China
Recruiting
JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 2745)
Jiamusi, Heilongjiang, China
Recruiting
Henan Cancer Hospital ( Site 2746)
Zhengzhou, Henan, China
Recruiting
Tongji Hospital Tongji Medical,Science & Technology ( Site 2722)
Wuhan, Hubei, China
Recruiting
Hubei Cancer Hospital ( Site 2721)
Wuhan, Hubei, China
Recruiting
Xiangya Hospital Central South University ( Site 2741)
Changsha, Hunan, China
Recruiting
Hunan Cancer Hospital ( Site 2710)
Changsha, Hunan, China
Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 2715)
Nanjing, Jiangsu, China
Active, not recruiting
Jiangxi Cancer Hospital ( Site 2725)
Nanchang, Jiangxi, China
Recruiting

Showing 60 of 215 sites — filter to narrow it down. 211 of the 215 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07190248. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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