NCT06203210

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The primary objective of this study is to assess whether treatment with I-DXd improves objective response rate (ORR) and prolongs overall survival (OS) compared with treatment of physician's choice among participants with relapsed SCLC. The secondary objectives of the study are to further evaluate the efficacy/safety of I-DXd, health economics and outcome research measures (including patient reported outcomes), immunogenicity of I-DXd, B7-H3 protein expression, and characterize the pharmacokinetics of I-DXd.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-05-21
• Primary completion: 2027-04-30
• Completion: 2029-02-22
• First posted: 2024-01-12
• Last updated: 2026-03-02

Locations

230 sites across 24 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

Regulatory

• FDA-regulated drug study