Study

Overview

Official Title: 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.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

675

Study Start Date:

October 2025

Estimated Study Completion Date:

August 2032

Estimated Primary Completion Date:

December 2029

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

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

Locations

United States Toll Free Number 1-800-770-4674

Birmingham, Alabama, 35209
Stamford, Connecticut, 06902
Miami Beach, Florida, 33140
Westbrook, Maine, 04092
Albany, New York, 12206
Lancaster, Pennsylvania, 17601
Roanoke, Virginia, 24014

Results

No Study Results Posted

Study Detail

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

Overview

Eligibility

CRITERIA

Locations

Results