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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: Recruiting Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
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 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
PFS is defined as the time from randomization until either documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PFS as determined by blinded independent central review (BICR) will be presented.
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 |
What NCT06345729 shows while recruiting
NCT06345729 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target.
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 names 20 study sites across 14 states, led by 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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Where NCT06345729's enrollment target sits among peer trials
600 57th of 454 higher than 396 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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