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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)

RecruitingPhase 3

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)

Who can join

Ages 18 and older · All sexes

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

About the 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.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 675 · Started: Oct 8, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07190248

Locations in the U.S.

AlabamaCentral Alabama Research ( Site 0108), Birmingham
ConnecticutUniversity of Connecticut Health Center ( Site 0130), Farmington
Stamford Hospital ( Site 0126), Stamford
IndianaIndiana University Health Arnett Cancer Center ( Site 0116), Lafayette
MaineNew England Cancer Specialists ( Site 0139), Westbrook
New JerseyJohn Theurer Cancer Center at Hackensack University Medical Center ( Site 0152), Hackensack
New YorkNew York Oncology Hematology, P.C. ( Site 0119), Albany
Wilmot Cancer Institute ( Site 0141), Rochester
OregonSt. Charles Health System, Inc ( Site 0146), Bend
PennsylvaniaLancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111), Lancaster
VirginiaHematology Oncology Associates of Fredericksburg ( Site 9550), Fredericksburg
Blue Ridge Cancer Care ( Site 0144), Roanoke

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.