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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)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
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
Start Date
October 8, 2025
Primary Completion Date
December 7, 2029
Completion Date
August 6, 2032
Last Updated
March 20, 2026
675
ESTIMATED participants
Calderasib
DRUG
Pembrolizumab (+) Berahyaluronidase alfa
BIOLOGICAL
Pemetrexed
DRUG
Cisplatin
DRUG
Carboplatin
DRUG
Lead Sponsor
Merck Sharp & Dohme LLC
NCT06305754
NCT07100080
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07195695