nctId: NCT06362252 id: DS7300-189 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) overallStatus: NOT_YET_RECRUITING date: 2024-06-17 date: 2026-11-30 date: 2026-12-30 date: 2024-04-12 date: 2024-04-12 name: Daiichi Sankyo class: INDUSTRY name: Merck Sharp & Dohme LLC 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. conditions: Extensive Stage-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 149 type: ESTIMATED name: Ifinatamab deruxtecan name: Atezolizumab name: Carboplatin name: Etoposide measure: Number of Participants Reporting Dose-limiting Toxicities Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A) 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) 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) 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) 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) 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) 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) 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) 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) measure: Overall Survival Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Pharmacokinetic Parameter Maximum Serum Concentration of I-DXd measure: Pharmacokinetic Parameter Time to Maximum Serum Concentration of I-DXd measure: Pharmacokinetic Parameter Area Under the Concentration Curve of I-DXd measure: The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have A Treatment-emergent Anti-Drug Antibody sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False