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Pembrolizumab / Calderasib / Non Small Cell Lung Cancer · Phase 3 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 trial registration for calderasib plus pembrolizumab in KRAS G12C-mutant NSCLC with high PD-L1 expression, currently recruiting. No results are posted in this registry record; the trial is designed with hard endpoints (PFS and OS) but remains preliminary until data are mature and published.
Phase 3, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Non-small Cell Lung Cancer; age from 18 Years. Intervention: Calderasib with Pembrolizumab. Compared with: Placebo with Pembrolizumab — Active Comparator. n = 600. 225 sites across 27 countries.
This is a Phase 3 trial registration for calderasib plus pembrolizumab in KRAS G12C-mutant NSCLC with high PD-L1 expression, currently recruiting. No results are posted in this registry record; the trial is designed with hard endpoints (PFS and OS) but remains preliminary until data are mature and published.
This registry record reports only study design and planned outcomes; no efficacy, safety, or effectiveness data are reported.
The source did not state who this applies to in practice.
This is a Phase 3 trial registration with no results posted; the study is actively recruiting and has not yet reported efficacy or safety outcomes.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06345729). This is a study registration, not published results. Lead sponsor: Merck Sharp & Dohme LLC. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 600 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer. Interventions: DRUG: Calderasib; OTHER: Placebo; BIOLOGICAL: Pembrolizumab. Primary outcome measures: Progression-Free Survival (PFS) , Up to approximately 42 months; Overall Survival (OS) , Up to approximately 56 months. Brief 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).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.