protocolSection identificationModule nctId: NCT06357533, orgStudyIdInfo 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2030-05-24, completionDateStruct date: 2030-05-24, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, collaborators name: Daiichi Sankyo, descriptionModule 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., conditionsModule conditions: Non-Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Open-label, sponsor-blinded, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 675, type: ESTIMATED, armsInterventionsModule interventions name: Datopotamab Deruxtecan, interventions name: Rilvegostomig, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Progression-Free Survival (PFS) in TROP2 biomarker positive participants., primaryOutcomes measure: Overall Survival (OS) in TROP2 biomarker positive participants., secondaryOutcomes measure: Progression-Free Survival (PFS) in the intent-to-treat (ITT) population., secondaryOutcomes measure: Overall Survival (OS) in the intent-to-treat (ITT) population., secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Participant-reported lung cancer symptoms of NSCLC in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab., secondaryOutcomes measure: Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab., secondaryOutcomes measure: Participant-reported GHS/QoL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab., secondaryOutcomes measure: Pharmacokinetics (PK), secondaryOutcomes measure: Immunogenicity, secondaryOutcomes measure: Second Progression-Free Survival (PFS2)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, city: Clayton, zip: 3168, country: Australia, geoPoint 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