protocolSection identificationModule nctId: NCT06305754, orgStudyIdInfo id: 2870-009, secondaryIdInfos id: 2023-504910-31, type: REGISTRY, domain: EU CT, secondaryIdInfos id: U1111-1288-3804, type: OTHER, domain: UTN, secondaryIdInfos id: MK-2870-009, type: OTHER, domain: Merck, briefTitle: Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) and Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-03, primaryCompletionDateStruct date: 2028-09-12, completionDateStruct date: 2030-06-14, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs).The primary hypotheses of this study are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to progression-free survival (PFS) and overall survival (OS)., conditionsModule conditions: Non-small Cell Lung Cancer (NSCLC), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Unblinded Open-label, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 520, type: ESTIMATED, armsInterventionsModule interventions name: Sacituzumab tirumotecan, interventions name: Pemetrexed, interventions name: Carboplatin, interventions name: Antihistamine, interventions name: H2 Receptor Antagonist, interventions name: Acetaminophen (or equivalent), interventions name: Dexamethasone (or equivalent), outcomesModule primaryOutcomes measure: Progression-Free Survival (PFS), primaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, secondaryOutcomes measure: Change From Baseline in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30, secondaryOutcomes measure: Change from Baseline in the Cough (Item 31) Score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13), secondaryOutcomes measure: Change from Baseline in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13, secondaryOutcomes measure: Time to Deterioration (TTD) in Global Health Status/Quality of Life (Items 29 and 30) Combined Score, on the EORTC QLQ-C30, secondaryOutcomes measure: TTD in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30, secondaryOutcomes measure: TTD in the Cough (Item 31) Score, on the EORTC QLQ-LC13, secondaryOutcomes measure: TTD in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13, secondaryOutcomes measure: Number of Participants Who Experience One or More Adverse Events (AEs), secondaryOutcomes measure: Number of Participants Who Discontinue Study Treatment Due to an AE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False