nctId: NCT06357533 id: D7632C00001 briefTitle: Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations acronym: TROPION-Lung10 overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2030-05-24 date: 2030-05-24 date: 2024-04-10 date: 2024-04-10 name: AstraZeneca class: INDUSTRY name: Daiichi Sankyo briefSummary: The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations. conditions: Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Open-label, sponsor-blinded whoMasked: OUTCOMES_ASSESSOR count: 675 type: ESTIMATED name: Datopotamab Deruxtecan name: Rilvegostomig name: Pembrolizumab measure: Progression-Free Survival (PFS) in TROP2 biomarker positive participants. measure: Overall Survival (OS) in TROP2 biomarker positive participants. measure: Progression-Free Survival (PFS) in the intent-to-treat (ITT) population. measure: Overall Survival (OS) in the intent-to-treat (ITT) population. measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) measure: Participant-reported lung cancer symptoms of NSCLC in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab. measure: Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab. measure: Participant-reported GHS/QoL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab. measure: Pharmacokinetics (PK) measure: Immunogenicity measure: Second Progression-Free Survival (PFS2). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Clayton zip: 3168 country: Australia lat: -37.91667 lon: 145.11667 facility: Research Site city: Melbourne zip: 3000 country: Australia lat: -37.814 lon: 144.96332 facility: Research Site city: South Brisbane zip: QL 4101 country: Australia lat: -27.48034 lon: 153.02049 facility: Research Site city: Innsbruck zip: 6020 country: Austria lat: 47.26266 lon: 11.39454 facility: Research Site city: Krems zip: 3500 country: Austria lat: 48.40921 lon: 15.61415 facility: Research Site city: Linz zip: 4020 country: Austria lat: 48.30639 lon: 14.28611 facility: Research Site city: Rankweil zip: 6830 country: Austria lat: 47.27108 lon: 9.64308 facility: Research Site city: Wien zip: 1140 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site 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