A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There is one primary study hypothesis: Combination of calderasib and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 26, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Merck Sharp & Dohme LLC
- Interventions being studied
- Drug: Calderasib; Other: Placebo; Biological: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
The main inclusion and
- include but are not limited to the following: Inclusion Criteria:
- Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
- Provides an archival tumor sample (≤5 years) or newly obtained core, incisional, or excisional biopsy or fine needle aspirate (FNA) of a tumor lesion, not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, programmed cell death ligand 1 (PD-L1) status, and biomarker research
- If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to \< Grade 1 or baseline
- If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)
- If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- CBCC Global Research, Inc. ( Site 0123)Bakersfield, California
- Beverly Hills Cancer Center ( Site 0116)Beverly Hills, California
- Stamford Hospital ( Site 0136)Stamford, Connecticut
- Mount Sinai Cancer Center ( Site 0137)Miami Beach, Florida
- Orchard Healthcare Research Inc. ( Site 0115)Skokie, Illinois
- Truman Medical Center ( Site 0126)Kansas City, Missouri
- Cox Medical Center North ( Site 0133)Springfield, Missouri
- St. Vincent Frontier Cancer Center-Research ( Site 0105)Billings, Montana
- Atlantic Health System Morristown Medical Center ( Site 0121)Morristown, New Jersey
- New York Oncology Hematology, P.C. ( Site 0132)Albany, New York
- University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103)Cincinnati, Ohio
- Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106)Kettering, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 26, 2026. Always confirm current availability with the study team.