protocolSection identificationModule nctId: NCT06333951, orgStudyIdInfo id: 20230167, briefTitle: AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-06-03, primaryCompletionDateStruct date: 2026-10-08, completionDateStruct date: 2029-10-07, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors., conditionsModule conditions: Thoracic Tumors, conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: AMG 193, interventions name: Carboplatin, interventions name: Paclitaxel, interventions name: Pembrolizumab, interventions name: Pemetrexed, interventions name: Sotorasib, outcomesModule primaryOutcomes measure: Number of Participants Experiencing Dose Limiting Toxicities (DLT), primaryOutcomes measure: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE), primaryOutcomes measure: Number of Participants Experiencing Serious Adverse Events (SAE), secondaryOutcomes measure: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), secondaryOutcomes measure: Disease Control (DC) per RECIST v1.1, secondaryOutcomes measure: Duration of Response (DOR) per RECIST v1.1, secondaryOutcomes measure: Time to Response (TTR) per RECIST v1.1, secondaryOutcomes measure: Overall Survival (OS) per RECIST v1.1, secondaryOutcomes measure: Progression-free Survival (PFS) per RECIST v1.1, secondaryOutcomes measure: Maximum Plasma Concentration (Cmax) of AMG 193, secondaryOutcomes measure: Time to Maximum Plasma Concentration (tmax) of AMG 193, secondaryOutcomes measure: Area Under the Plasma Concentration-time Curve (AUC) of AMG 193, secondaryOutcomes measure: Intracranial objective response (IOR) per Response Assessment in Neuro Oncology Brain Metastases (RANO-BM ), secondaryOutcomes measure: Intracranial Disease Control (IDC) per RANO-BM, secondaryOutcomes measure: Intracranial Duration of Response (IDOR) per RANO-BM, secondaryOutcomes measure: Time to Intracranial Radiation Therapy per RANO-BM, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope (COH), status: RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, geoPoint lat: 34.13945, lon: -117.97729, hasResults: False