RecruitingPhase 3NCT07190248

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

Checked against the public recordLast updated Aug 28, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 3
U.S. locations205
SponsorMerck Sharp & Dohme LLC
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Merck Sharp & Dohme LLC
Interventions being studied
Drug: Calderasib; Biological: Pembrolizumab (+) Berahyaluronidase alfa; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Central Alabama Research ( Site 0108)Birmingham, Alabama
  • University of Connecticut Health Center ( Site 0130)Farmington, Connecticut
  • Stamford Hospital ( Site 0126)Stamford, Connecticut
  • Mount Sinai Cancer Center ( Site 0137)Miami Beach, Florida
  • Indiana University Health Arnett Cancer Center ( Site 0116)Lafayette, Indiana
  • New England Cancer Specialists ( Site 0139)Westbrook, Maine
  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0152)Hackensack, New Jersey
  • New York Oncology Hematology, P.C. ( Site 0119)Albany, New York
  • Wilmot Cancer Institute ( Site 0141)Rochester, New York
  • St. Charles Health System, Inc ( Site 0146)Bend, Oregon
  • Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)Lancaster, Pennsylvania
  • Blue Ridge Cancer Care ( Site 0144)Roanoke, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 28, 2026. Always confirm current availability with the study team.

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