protocolSection identificationModule nctId: NCT06312137, orgStudyIdInfo id: 2870-019, secondaryIdInfos id: 2023-508012-35, type: REGISTRY, domain: EU CT, secondaryIdInfos id: MK-2870-019, type: OTHER, domain: Merck Id, briefTitle: A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2034-02-21, completionDateStruct date: 2034-10-23, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, descriptionModule briefSummary: This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR)., conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a multi site study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 780, type: ESTIMATED, armsInterventionsModule interventions name: Sacituzumab tirumotecan, interventions name: Pembrolizumab, interventions name: Cisplatin, interventions name: Pemetrexed, interventions name: Gemcitabine, interventions name: Carboplatin, interventions name: Paclitaxel, outcomesModule primaryOutcomes measure: Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Distant metastasis-free survival (DMFS) as assessed by investigator, secondaryOutcomes measure: Disease-Free Survival (DFS) as assessed by investigator, secondaryOutcomes measure: Lung Cancer Specific Survival (LCSS), secondaryOutcomes measure: Number of Participants Who Experience at least One Adverse Event (AE), secondaryOutcomes measure: Number of Participants Who Discontinue Study Intervention Due to AEs, secondaryOutcomes measure: Change from Baseline in Global Health Status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30), secondaryOutcomes measure: Change from Baseline in Physical Functioning Score (QLQ-C30 Items 1 to 5), secondaryOutcomes measure: Change from Baseline in Role Functioning Score (QLQ-C30 Items 6 and 7), secondaryOutcomes measure: Change from Baseline in Dyspnea scores (QLQ-C30 Item 8), secondaryOutcomes measure: Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52), secondaryOutcomes measure: Change from Baseline in Chest pain scores (QLQ-LC24 Item 40), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mid Florida Hematology and Oncology Center ( Site 0018), status: RECRUITING, city: Orange City, state: Florida, zip: 32763, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 407-353-1915, geoPoint lat: 28.94888, lon: -81.29867, locations facility: Rambam Health Care Campus-Oncology Division ( Site 2203), status: RECRUITING, city: Haifa, zip: 3109601, country: Israel, contacts name: Study Coordinator, role: CONTACT, phone: 04-777-6700, geoPoint lat: 32.81841, lon: 34.9885, locations facility: Shaare Zedek Medical Center ( Site 2206), status: RECRUITING, city: Jerusalem, zip: 9103102, country: Israel, contacts name: Study Coordinator, role: CONTACT, phone: +972587040620, geoPoint lat: 31.76904, lon: 35.21633, locations facility: Rabin Medical Center ( Site 2204), status: RECRUITING, city: Petah Tikva, zip: 4941 492, country: Israel, contacts name: Study Coordinator, role: CONTACT, phone: + 9729378101, geoPoint lat: 32.08707, lon: 34.88747, locations facility: National Cheng Kung University Hospital-Clinical Trial Center ( Site 1102), status: RECRUITING, city: Tainan, zip: 704, country: Taiwan, contacts name: Study Coordinator, role: CONTACT, phone: 886-912777918, geoPoint lat: 22.99083, lon: 120.21333, hasResults: False