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Intismeran autogene / Pembrolizumab / Non Small Cell Lung Cancer · Phase 3 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 randomized controlled trial registration comparing intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for adjuvant treatment of completely resected, margin-negative Stage II–IIIB NSCLC. The study is currently recruiting and no results have been posted to the registry; the primary endpoint is disease-free survival over approximately 78 months of follow-up.
Phase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Non-small Cell Lung Cancer; age from 18 Years. Intervention: Intismeran autogene + Pembrolizumab. Compared with: Placebo + Pembrolizumab — Active Comparator. n = 868. 228 sites across 33 countries.
This is a Phase 3 randomized controlled trial registration comparing intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for adjuvant treatment of completely resected, margin-negative Stage II–IIIB NSCLC. The study is currently recruiting and no results have been posted to the registry; the primary endpoint is disease-free survival over approximately 78 months of follow-up.
Safety, secondary endpoints, and subgroup analyses are not reported.
No clinical impact can be drawn from this registry record, as no results have been reported. Clinicians and researchers should await primary outcome publication before interpreting efficacy or safety.
This is a Phase 3 registry record with no reported results; the study is actively recruiting and outcomes have not yet been posted.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be drawn from this registry record, as no results have been reported. Clinicians and researchers should await primary outcome publication before interpreting efficacy or safety.
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 (NCT06077760). This is a study registration, not published results. Lead sponsor: Merck Sharp & Dohme LLC. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 868 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer. Interventions: BIOLOGICAL: Intismeran autogene; BIOLOGICAL: Pembrolizumab; OTHER: Placebo. Primary outcome measures: Disease- Free Survival (DFS) , Up to ~78 months. Brief summary: The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.