A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
NCT06203210 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540
Last updated 2026-03-02
Summary
This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).
Conditions
Interventions
- DRUG
-
Ifinatamab deruxtecan
12 mg/kg intravenous dose on Day 1 of each 21-day cycle
- DRUG
-
Topotecan
Topotecan will be administered per local SoC.
- DRUG
-
Amrubicin
Amrubicin will be administered per local SoC.
- DRUG
-
Lurbinectedin
Lurbinectedin will be administered per local SoC
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Global Clinical Director · Daiichi Sankyo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-21
- Primary Completion
- 2027-04-30
- Completion
- 2029-02-22
- FDA Drug
- Yes
Countries
- United States
- Australia
- Austria
- Belgium
- Brazil
- Canada
- China
- Czechia
- France
- Germany
- Greece
- Hungary
- Italy
- Japan
- Netherlands
- Poland
- Portugal
- Romania
- South Korea
- Spain
- Switzerland
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
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