Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT06345729 · View on ClinicalTrials.gov ↗
Study Summary
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 are two primary study hypotheses: Hypothesis 1: 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). Hypothesis 2: Combination of calderasib plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Placebo
- DRUG Calderasib
Study Locations (20)
Buenos Aires
- AUSTRAL MEDICAL CENTER ( Site 0302) — CABA
- Centro Oncologico Korben ( Site 0304) — CABA
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300) — Mar del Plata
California
- CBCC Global Research, Inc. ( Site 0123) — Bakersfield
- Beverly Hills Cancer Center ( Site 0116) — Beverly Hills
Missouri
- Truman Medical Center ( Site 0126) — Kansas City
- Cox Medical Center North ( Site 0133) — Springfield
Ohio
- University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103) — Cincinnati
- Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106) — Kettering
Santa Fe Province
- Fundacion Estudios Clinicos ( Site 0306) — Rosario
- Sanatorio Parque ( Site 0301) — Rosario
Connecticut
- Stamford Hospital ( Site 0136) — Stamford
Florida
- Mount Sinai Cancer Center ( Site 0137) — Miami Beach
Illinois
- Orchard Healthcare Research Inc. ( Site 0115) — Skokie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2024-05-24 |
| Est. Completion | 2031-02-18 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06345729
The ClinicalTrials.gov registry entry for NCT06345729 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06345729 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Buenos Aires, California, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06345729 about?
NCT06345729 is a clinical study titled "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 ...
What is the current status of trial NCT06345729?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2024-05-24. Estimated completion is 2031-02-18.
What conditions does trial NCT06345729 study?
This clinical trial studies the following conditions: Non-small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06345729?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (OTHER), Calderasib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06345729?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06345729 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.