protocolSection identificationModule nctId: NCT06362252, orgStudyIdInfo id: DS7300-189, secondaryIdInfos id: 2023-509629-36, type: OTHER, domain: EU CT, briefTitle: A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-17, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Daiichi Sankyo, class: INDUSTRY, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: This study is designed to evaluate the safety and efficacy of ifinatamab deruxtecan (I-DXd) in combination with immune checkpoint inhibitor (ICI) atezolizumab with or without carboplatin in participants with extensive stage-small cell lung cancer (ES-SCLC) in the first-line (1L) setting., conditionsModule conditions: Extensive Stage-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 149, type: ESTIMATED, armsInterventionsModule interventions name: Ifinatamab deruxtecan, interventions name: Atezolizumab, interventions name: Carboplatin, interventions name: Etoposide, outcomesModule primaryOutcomes measure: Number of Participants Reporting Dose-limiting Toxicities Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A), primaryOutcomes measure: Overall Number of Participants With Treatment-emergent Adverse Events Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Progression-free Survival As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Duration of Response As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Disease Control Rate As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Clinical Benefit Rate as Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Time to Response As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Overall Survival Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Pharmacokinetic Parameter Maximum Serum Concentration of I-DXd, secondaryOutcomes measure: Pharmacokinetic Parameter Time to Maximum Serum Concentration of I-DXd, secondaryOutcomes measure: Pharmacokinetic Parameter Area Under the Concentration Curve of I-DXd, secondaryOutcomes measure: The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have A Treatment-emergent Anti-Drug Antibody, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False