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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)

StatusRecruiting
PhasePhase 1/2
Started2024-07-22
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Sep 30, 2026 → Jul 20, 2027
See other at-risk trials from Daiichi Sankyo

Amendment history

2026-10-02
Primary completion pushed: 2026-09-30 → 2027-07-20
Completion pushed: 2026-12-30 → 2028-02-20
2026-02-04
Study Status, Contacts/Locations v13
Study sites58 entries, revised
Assistance Publique-Hă"PitauxHôpital de Marseillela Timone ChuCHU Nantes - Hă"PitalHôpital Guillaume Etet RenăRené Laă<NnecLaënnec Hă"PitalHôpital Foch IcoICO Ll'Hospitalet - Hospital Duran Ii Reynals
2025-10-08
Study Status, Contacts/Locations v12
Study sites56→58
2025-09-05
Study Status, Arms and Interventions, Contacts/Locations v11
Study sites56 entries, revised
Assistance Publique-Hă"PitauxHăpitaux de Marseille Chu Nantes - Hă"PitalHăpital Guillaume Et Renă Laă<NnecLaănnec Hă"PitalHăpital Foch
2025-09-03
Study Status, Contacts/Locations v10
Study sitesdetails revised at 1 of 56 sites
Show 9 earlier versions
2025-07-29
Study Status, Contacts/Locations v9
Study sites51→56
2025-06-13
Study Status, Contacts/Locations v8
Study sites50→51
2025-05-12
Study Status, Contacts/Locations v7
Study sites51→50
2025-04-14
Study Status, Contacts/Locations v6
Study sites50→51
2025-01-07
Study Status, Contacts/Locations v5
Study sites50 entries, revised
Assistance Publique-HăpitauxHă"Pitaux de Marseille Chu Nantes - HăpitalHă"Pital Guillaume Et Renă LaănnecLaă<Nnec HăpitalHă"Pital Foch
2024-11-21
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 50 sites
2024-11-11
Study Identification, Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Primary completion date2026-11-30→2026-09-30
Enrollment target149→123
Study sites49→50
InterventionsAtezolizumab (Drug), Carboplatin (Drug), Etoposide (Drug), Ifinatamab deruxtecan (Drug)→Atezolizumab (Drug), Carboplatin (Drug), Ifinatamab deruxtecan (Drug)
Eligibility criteria+618 characters
A full list of inclusion/exclusion criteria are available in the protocol. Inclusion Criteria Participants must meet all of the followi [...] confirmed diagnosis of ES-SCLC who will require first-line (IL) therapy. For Cohort 1 Part A, participant has received 4 cycles of 1L induction therapy [...] SD per RECIST v1.1 assessed by the investigator. For Cohort 1 Part B and Cohort 2, participant has received no prior treatment for ES-SCLC. 5. For Cohort 1 Part B and Cohort 2, participant has at least one measurable lesion ac [...] ic resonance imaging (MRI) as assessed by the investigator. 6. For Cohort 1 Part B and [...]
Secondary endpoints12 entries, revised
Number of Participants With Objective Response Rate Assessed by Blinded Independent Cent [...] gator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B of Cohort 2 Only) Duration of Response As Assessed by Blinded Independent Ce [...] gator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B of Cohort 2 Only) Disease Control Rate As Assessed by Blinded Independent Ce [...] gator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B of Cohort 2 Only) Clinical Benefit Rate as Assessed by Blinded Indepe [...] [...]
2024-09-12
Study Status, Contacts/Locations v2
Study sites48→49
2024-08-27
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-06-17→confirmed 2024-07-22
Study sites0→48
2024-04-08
Original filing
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.
Trial Details
NCT Number NCT06362252
Lead Sponsor Daiichi Sankyo
Collaborators: Merck Sharp & Dohme LLC
Conditions Extensive Stage-small Cell Lung Cancer
Enrollment 123 participants
Start Date 2024-07-22
Primary Completion 2027-07-20 (estimated)
Study Completion 2028-02-20 (estimated)
Updated on ClinicalTrials.gov 2026-10-01