{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"IDeate-Lung03","nct_id":"NCT06362252","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ideate-lung03-nct06362252. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Part A (Safety Run-in): Participants who must have received 4 cycles of 1L induction standard of care (SoC) therapy with best overall response of CR, PR, or SD will receive maintenance therapy only. Maintenance therapy consisting of I-DXd 12 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.\n\nA 5-day surveillance period between each of the first 3 participants (up to a maximum of 9 participants) dosed is included as a safety measure.","label":"Cohort 1, Part A: Maintenance Only (I-DXd 12 mg/kg)","type":"EXPERIMENTAL"},{"description":"Part A (Safety Run-in): Participants who are treatment-naive, newly diagnosed with ES-SCLC will receive 4 cycles of 1L I-DXd induction therapy (8 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W) + carboplatin (AUC 5 mg/ml×min IV Q3W) followed by maintenance therapy. Maintenance therapy consisting of I-DXd 8 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.","label":"Cohort 2, Part A: Induction + Maintenance (I-DXd 8 mg/kg)","type":"EXPERIMENTAL"},{"description":"Part A (Safety Run-in): Participants who are treatment-naive, newly diagnosed with ES-SCLC will receive 4 cycles of 1L I-DXd induction therapy (12 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W) + carboplatin (AUC 5 mg/ml×min IV Q3W) followed by maintenance therapy. Maintenance therapy consisting of I-DXd 12 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.","label":"Cohort 2, Part A: Induction + Maintenance (I-DXd 12 mg/kg)","type":"EXPERIMENTAL"},{"description":"Part B: Participants who must have received 4 cycles of 1L induction standard of care (SoC) therapy with best overall response of CR, PR, or SD will receive maintenance therapy only starting at Cycle 1 Day 1. Maintenance therapy consisting of I-DXd 8 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W","label":"Cohort 1, Part B: Maintenance (I-DXd 8 mg/kg)","type":"EXPERIMENTAL"},{"description":"Part B: Participants who must have received 4 cycles of 1L induction standard of care (SoC) therapy with best overall response of CR, PR, or SD will receive maintenance therapy only starting at Cycle 1 Day 1. Maintenance therapy consisting of I-DXd 12 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.","label":"Cohort 1, Part B: Maintenance (I-DXd 12 mg/kg)","type":"EXPERIMENTAL"},{"description":"Participants who are treatment-naive, newly diagnosed with ES-SCLC will receive 4 cycles of 1L I-DXd induction therapy (8 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W) + carboplatin (AUC 5 mg/ml×min IV Q3W) followed by maintenance therapy. Maintenance therapy consisting of I-DXd 8 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.","label":"Cohort 2, Part B: Induction + Maintenance (I-DXd 8 mg/kg)","type":"EXPERIMENTAL"},{"description":"Participants who are treatment-naive, newly diagnosed with ES-SCLC will receive 4 cycles of IL I-DXd induction therapy (12 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W) + carboplatin (AUC 5 mg/ml×minIV Q3W) followed by maintenance therapy. Maintenance therapy consisting of I-DXd 12 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.","label":"Cohort 2, Part B: Induction + Maintenance (I-DXd 12 mg/kg)","type":"EXPERIMENTAL"}],"collaborators":["Merck Sharp & Dohme LLC"],"completion_date":{"date":"2028-02-20","type":"ESTIMATED"},"conditions":["Extensive Stage-small Cell Lung Cancer"],"enrollment":{"count":123,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Ifinatamab deruxtecan","otherNames":["I-DXd"],"type":"DRUG"},{"name":"Atezolizumab","otherNames":[],"type":"DRUG"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"}],"last_update":"2026-10-01","lead_sponsor":"Daiichi Sankyo","official_title":"A Phase 1b/2, Multicenter, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody-Drug Conjugate (ADC), in Combination With Atezolizumab With or Without Carboplatin as First-line Induction or Maintenance, in Subjects With Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung03)","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-07-20","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Number of Participants Reporting Dose-limiting Toxicities Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A)","timeFrame":"Cycle 1 Day 1 up to Cycle 1 Day 21 (each cycle is 21 days)"},{"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)","timeFrame":"Baseline up to 37 months"}],"references":[],"start_date":{"date":"2024-07-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"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)","url":"https://clinicaltrials.gov/study/NCT06362252"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/ideate-lung03-nct06362252"}