nctId: NCT06312137 id: 2870-019 id: 2023-508012-35 type: REGISTRY domain: EU CT 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) overallStatus: RECRUITING date: 2024-04-03 date: 2034-02-21 date: 2034-10-23 date: 2024-03-15 date: 2024-04-25 name: Merck Sharp & Dohme LLC class: INDUSTRY 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). conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a multi site study primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 780 type: ESTIMATED name: Sacituzumab tirumotecan name: Pembrolizumab name: Cisplatin name: Pemetrexed name: Gemcitabine name: Carboplatin name: Paclitaxel measure: Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR) measure: Overall Survival (OS) measure: Distant metastasis-free survival (DMFS) as assessed by investigator measure: Disease-Free Survival (DFS) as assessed by investigator measure: Lung Cancer Specific Survival (LCSS) measure: Number of Participants Who Experience at least One Adverse Event (AE) measure: Number of Participants Who Discontinue Study Intervention Due to AEs measure: Change from Baseline in Global Health Status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30) measure: Change from Baseline in Physical Functioning Score (QLQ-C30 Items 1 to 5) measure: Change from Baseline in Role Functioning Score (QLQ-C30 Items 6 and 7) measure: Change from Baseline in Dyspnea scores (QLQ-C30 Item 8) measure: Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52) measure: Change from Baseline in Chest pain scores (QLQ-LC24 Item 40) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mid Florida Hematology and Oncology Center ( Site 0018) status: RECRUITING city: Orange City state: Florida zip: 32763 country: United States name: Study Coordinator role: CONTACT phone: 407-353-1915 lat: 28.94888 lon: -81.29867 facility: Rambam Health Care Campus-Oncology Division ( Site 2203) status: RECRUITING city: Haifa zip: 3109601 country: Israel name: Study Coordinator role: CONTACT phone: 04-777-6700 lat: 32.81841 lon: 34.9885 facility: Shaare Zedek Medical Center ( Site 2206) status: RECRUITING city: Jerusalem zip: 9103102 country: Israel name: Study Coordinator role: CONTACT phone: +972587040620 lat: 31.76904 lon: 35.21633 facility: Rabin Medical Center ( Site 2204) status: RECRUITING city: Petah Tikva zip: 4941 492 country: Israel name: Study Coordinator role: CONTACT phone: + 9729378101 lat: 32.08707 lon: 34.88747 facility: National Cheng Kung University Hospital-Clinical Trial Center ( Site 1102) status: RECRUITING city: Tainan zip: 704 country: Taiwan name: Study Coordinator role: CONTACT phone: 886-912777918 lat: 22.99083 lon: 120.21333 hasResults: False