protocolSection identificationModule nctId: NCT06287775, orgStudyIdInfo id: NCI-2024-01398, secondaryIdInfos id: NCI-2024-01398, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 10629, type: OTHER, domain: JHU Sidney Kimmel Comprehensive Cancer Center LAO, secondaryIdInfos id: 10629, type: OTHER, domain: CTEP, secondaryIdInfos id: UM1CA186691, type: NIH, link: https://reporter.nih.gov/quickSearch/UM1CA186691, briefTitle: Testing the Combination of an Anti-cancer Drug, Iadademstat, With Other Anti-cancer Drugs (Atezolizumab or Durvalumab) at Improving Outcomes for Small Cell Lung Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-24, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase I/II trial tests the safety, side effects, and best dose of iadademstat when given together with atezolizumab or durvalumab, and studies the effect of the combination in treating patients with small cell lung cancer that has spread outside of the lung in which it began or to other parts of the body (extensive stage) who initially received standard of care chemotherapy and immunotherapy. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in treating patients with extensive stage small cell lung cancer., conditionsModule conditions: Extensive Stage Lung Small Cell Carcinoma, conditions: Stage IV Lung Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Atezolizumab, interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Durvalumab, interventions name: Echocardiography, interventions name: Iadademstat, interventions name: Magnetic Resonance Imaging, interventions name: Multigated Acquisition Scan, outcomesModule primaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Incidence of adverse events, otherOutcomes measure: Detection of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) minimal residual disease, otherOutcomes measure: Impact of iadademstat on the correlation of immune checkpoint inhibitors (ICIs) and the presence of cachexia, otherOutcomes measure: Exposure response relationships of iadademstat in combination with ICIs, otherOutcomes measure: Changes to small cell lung cancer subtype, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False