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Clinical Trials in the UK / NCT07190248
Recruiting Phase 3

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

NCT07190248 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2025-10-08
Last updated
2026-09-14

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

CalderasibPembrolizumab (+) Berahyaluronidase alfaPemetrexedCisplatinCarboplatin

Calderasib: Administered as an oral tablet

Pembrolizumab (+) Berahyaluronidase alfa: Administered as a SC injection

Pemetrexed: Administered as an IV Infusion

Cisplatin: Administered as an IV Infusion

Carboplatin: Administered as an IV Infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (211)

FacilityCityRegionStatus
Central Alabama Research ( Site 0108) Birmingham Alabama Recruiting
University of Connecticut Health Center ( Site 0130) Farmington Connecticut Recruiting
Stamford Hospital ( Site 0126) Stamford Connecticut Recruiting
Mount Sinai Cancer Center ( Site 0137) Miami Beach Florida Completed
Indiana University Health Arnett Cancer Center ( Site 0116) Lafayette Indiana Recruiting
New England Cancer Specialists ( Site 0139) Westbrook Maine Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0152) Hackensack New Jersey Recruiting
New York Oncology Hematology, P.C. ( Site 0119) Albany New York Recruiting
Wilmot Cancer Institute ( Site 0141) Rochester New York Recruiting
St. Charles Health System, Inc ( Site 0146) Bend Oregon Recruiting
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111) Lancaster Pennsylvania Recruiting
Hematology Oncology Associates of Fredericksburg ( Site 9550) Fredericksburg Virginia Recruiting
Blue Ridge Cancer Care ( Site 0144) Roanoke Virginia Recruiting
Instituto Alexander Fleming ( Site 0311) Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300) Mar del Plata Buenos Aires 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 Recruiting
Northern Beaches Hospital ( Site 2905) Frenchs Forest New South Wales Recruiting
The Prince Charles Hospital ( Site 2903) Brisbane Queensland Recruiting
Mater Hospital Brisbane ( Site 2906) South Brisbane Queensland Recruiting
Peninsula & South Eastern Haematology and Oncology Group ( Site 2908) Frankston Victoria Recruiting
Klinikum Klagenfurt am Wörthersee ( Site 1002) Klagenfurt Carinthia Recruiting
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1005) Graz Styria Recruiting
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1001) Vienna Austria Recruiting
Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3903) Genk Limburg Recruiting
VITAZ ( Site 3902) Sint-Niklaas Oost-Vlaanderen Recruiting
Clinical Chc Montlégia ( Site 3901) Liège Belgium Recruiting
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0412) Fortaleza Ceará Recruiting
Hospital Santa Rita de Cassia ( Site 0403) Vitória Espírito Santo Recruiting
Real Hospital Portugues ( Site 0418) Recife Pernambuco Recruiting
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa ( Site 0400) Porto Alegre Rio Grande do Sul Recruiting
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0410) Florianópolis Santa Catarina Recruiting
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto USP ( Site 0419) Ribeirão Preto São Paulo Recruiting
Faculdade de Medicina do ABC ( Site 0411) Santo André São Paulo Recruiting
Hospital Alemao Oswaldo Cruz ( Site 0413) São Paulo São Paulo Recruiting
IBCC - Núcleo de Pesquisa e Ensino ( Site 0417) São Paulo Brazil Recruiting
Cross Cancer Institute ( Site 0203) Edmonton Alberta Recruiting
Centro de Estudios Clínicos SAGA ( Site 0503) Santiago Region M. de Santiago Recruiting
FALP ( Site 0500) Santiago Region M. de Santiago Recruiting

+ 171 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07190248 on ClinicalTrials.gov ↗ ← All trials in the UK