Clinical Trial

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Study acronym: IDeate-Lung01
Active, Not Recruiting Phase 2
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Summary
This 2-part study intends to define the recommended Phase 2 dose of ifinatamab deruxtecan (I-DXd) based on the efficacy, safety, and pharmacokinetics (PK) results observed in participants with Extensive-stage Small Cell Lung Cancer (ES-SCLC) who received at least 1 prior line of platinum-based chemotherapy and a maximum of 3 prior lines of therapy (Part 1) and a minimum of two previous lines of systemic therapy (Part 2). This study will also investigate I-DXd anti-tumor activity in this population.
Protocol Amendment History 26 amendments
This ClinicalTrials.gov record has been amended 26 times since 2022-03-04; most recent amendment 2026-02-23.
Status change: Recruiting → Active, Not Recruiting 2024-06-14
Status change: Active, Not Recruiting → Recruiting 2024-01-12
Status change: Recruiting → Active, Not Recruiting 2023-04-28
Status change: Not Yet Recruiting → Recruiting 2022-05-16
Trial Details
NCT Number NCT05280470
Lead Sponsor Daiichi Sankyo
Collaborators: Merck Sharp & Dohme LLC
Conditions Extensive-stage Small-cell Lung Cancer
Enrollment 187 participants
Start Date 2022-03-09
Primary Completion 2025-03-03 (estimated)
Study Completion 2026-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-02-25