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Datopotamab Deruxtecan / Metastatic Non Small Cell Lung Cancer / Pembrolizumab · Phase 3 Trial
ClinicalTrials.gov · August 19, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registration for a Phase 3 randomized controlled trial of datopotamab deruxtecan plus pembrolizumab versus pembrolizumab monotherapy in first-line advanced or metastatic NSCLC. No efficacy or safety results are reported in this registry record; the trial remains active and not yet recruiting new participants.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Metastatic Non Small Cell Lung Cancer; age from 18 Years. Intervention: Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd). Compared with: Pembrolizumb — Active Comparator. n = 740. 234 sites across 28 countries.
This is a clinical trial registration for a Phase 3 randomized controlled trial of datopotamab deruxtecan plus pembrolizumab versus pembrolizumab monotherapy in first-line advanced or metastatic NSCLC. No efficacy or safety results are reported in this registry record; the trial remains active and not yet recruiting new participants.
This is a registry record with no reported results; no efficacy, safety, or comparative effectiveness data are available
No clinical impact can be assessed from this registry record as results are not posted. Clinicians should await publication of trial results before drawing conclusions about the efficacy or safety of this combination regimen.
This is a clinical trial registry record describing an active Phase 3 study with no results posted; the planned design is sound but efficacy and safety outcomes remain unreported.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed from this registry record as results are not posted. Clinicians should await publication of trial results before drawing conclusions about the efficacy or safety of this combination regimen.
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 (NCT05215340). This is a study registration, not published results. Lead sponsor: Daiichi Sankyo. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 740 participants (ACTUAL). Conditions: Metastatic Non Small Cell Lung Cancer. Interventions: DRUG: Datopotamab Deruxtecan; DRUG: Pembrolizumab. Primary outcome measures: Progression-free Survival Based on Blinded Independent Central Review in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab , From randomization until disease progression or death (whichever occurs first), up to approximately 46 months; Overall Survival (OS) in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab , From randomization until date of death due to any cause, up to approximately 72 months. Brief summary: This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.