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)
Public ClinicalTrials.gov record NCT06345729. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT06345729
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 600 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 23, 2024
- Primary completion
- Feb 18, 2029
- Completion
- Feb 17, 2031
- Last update posted
- Jun 14, 2026
2024 – 2031
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CBCC Global Research, Inc. ( Site 0123) | Bakersfield | California | 93309 | Recruiting |
| Beverly Hills Cancer Center ( Site 0116) | Beverly Hills | California | 90211 | Recruiting |
| Stamford Hospital ( Site 0136) | Stamford | Connecticut | 06902 | Recruiting |
| Mount Sinai Cancer Center ( Site 0137) | Miami Beach | Florida | 33140 | Completed |
| Orchard Healthcare Research Inc. ( Site 0115) | Skokie | Illinois | 60077 | Recruiting |
| Truman Medical Center ( Site 0126) | Kansas City | Missouri | 64108 | Recruiting |
| Cox Medical Center North ( Site 0133) | Springfield | Missouri | 65807 | Recruiting |
| St. Vincent Frontier Cancer Center-Research ( Site 0105) | Billings | Montana | 59102 | Recruiting |
| Atlantic Health System Morristown Medical Center ( Site 0121) | Morristown | New Jersey | 07960 | Recruiting |
| New York Oncology Hematology, P.C. ( Site 0132) | Albany | New York | 12206 | Recruiting |
| University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103) | Cincinnati | Ohio | 45219 | Recruiting |
| Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106) | Kettering | Ohio | 45429 | Completed |
| Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0134) | Lancaster | Pennsylvania | 17601 | Recruiting |
| Oncology Consultants P.A. ( Site 0113) | Houston | Texas | 77030 | Recruiting |
| Circuit Clinical/SSM Health Dean Medical Group ( Site 0129) | Madison | Wisconsin | 53715 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 210 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06345729, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 14, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06345729 live on ClinicalTrials.gov.