Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 9, 2026
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Phase 3 Trial.
No findings were extractable from the material analysed.
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Registry record from ClinicalTrials.gov (NCT05687266). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1350 participants (ACTUAL). Conditions: NSCLC. Interventions: DRUG: Datopotamab deruxtecan; DRUG: Durvalumab; DRUG: Carboplatin; DRUG: Pembrolizumab; DRUG: Cisplatin; DRUG: Pemetrexed; DRUG: Paclitaxel. Primary outcome measures: Progression-Free Survival (PFS) by blinded independent central review (BICR) in the non-squamous TROP2 biomarker positive population , Approximately 3 years; Overall Survival (OS) in the non-squamous TROP2 biomarker positive population , Approximately 5 years; PFS by BICR in the non-squamous population , Approximately 3 years; OS in the non-squamous population , Approximately 5 years. Brief summary: This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).