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NCT06345729 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT06345729 is a Phase 3 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 600 participants, roughly in line with the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target. The trial reports 20 study locations across 14 states.
The verdict
NCT06345729, a Phase 3 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
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?
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, categorized as Phase 3. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT06345729 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Buenos Aires, California, Missouri.
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.
What interventions are being tested in trial NCT06345729?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (OTHER), Calderasib (DRUG).
Who is sponsoring clinical trial NCT06345729?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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