protocolSection identificationModule nctId: NCT06315010, orgStudyIdInfo id: MedOPP662, secondaryIdInfos id: CA127-1061, type: OTHER, domain: Bristol-Myers Squibb GmbH & Co, secondaryIdInfos id: 2023-508112-35, type: EUDRACT_NUMBER, briefTitle: REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis, acronym: REPOSE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: MedSIR, class: OTHER, collaborators name: Medical University of Vienna, descriptionModule briefSummary: REPOSE is a phase II clinical trial exploring the safety and efficacy of repotrectinib in patients with non-small cell lung cancer (NSCLC) characterized by the presence of brain metastasis (BM) and whose tumors have mutated ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene., conditionsModule conditions: NSCLC, conditions: Brain Metastases, conditions: ROS1 Gene Rearrangement, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Repotrectinib, outcomesModule primaryOutcomes measure: Intracranial Objective Response Rate (IC-ORR), secondaryOutcomes measure: Clinical Benefit Rate (CBR) for intracranial (IC) lesions, secondaryOutcomes measure: Disease Control Rate (DCR) for IC lesions, secondaryOutcomes measure: Time to Response (TTR) for IC lesions, secondaryOutcomes measure: Duration of Response (DoR) for IC lesions, secondaryOutcomes measure: Objective Response Rate for extracranial (EC) and overall lesions (EC-ORR), secondaryOutcomes measure: CBR for EC and overall lesions, secondaryOutcomes measure: DCR for EC and overall lesions, secondaryOutcomes measure: TTR for EC and overall lesions, secondaryOutcomes measure: DoR for EC and overall lesions, secondaryOutcomes measure: Best percentage of change in tumor burden, secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Neurologic function, secondaryOutcomes measure: Quality of life (QoL) with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30), secondaryOutcomes measure: QoL with the brain cancer specific questionnaire (QLQ-C20)., secondaryOutcomes measure: Safety and tolerability, otherOutcomes measure: Exploratory endpoint: Genetic studies using blood samples to investigate the potential association with clinical outcomes, otherOutcomes measure: Exploratory endpoint: ROS1 gene expression analysis using baseline tissue samples to investigate the potential association with clinical outcomes, otherOutcomes measure: Exploratory endpoint: Analysis of medical imaging to identify potential biomarkers associated with clinical outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False