CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 540 target
Drug / intervention
Ifinatamab deruxtecan +3 moredrug
Likely dose
Ifinatamab deruxtecan 12 mg/kgfrom record
Key inclusion· 6
  • ✓Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC)
  • ✓One prior platinum-based chemotherapy line with at least 2 cycles and ≥30 days chemotherapy-free interval
  • ✓At least 1 measurable lesion per RECIST v1.1
  • ✓Documented radiological disease progression on or after most recent systemic therapy
Key exclusion· 8
  • ✕Prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents including I-DXd
  • ✕Prior ADC discontinuation due to treatment-related toxicities with exatecan derivatives (e.g., trastuzumab deruxtecan)
  • ✕Prior treatment with study comparators or topoisomerase I inhibitors
  • ✕Any history of ILD/pneumonitis irrespective of steroid use, or current/suspected ILD, except radiation pneumonitis not requiring steroids

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06203210
NCT06203210Phase 3RecruitingHigh Momentum
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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)

Daiichi Sankyo·interventional·Posted Jan 12, 2024·Updated Jun 2, 2026

In Brief

A Phase 3 clinical trial evaluating Ifinatamab deruxtecan, Topotecan, and 2 other interventions for Small Cell Lung Cancer. Currently recruiting, targeting 540 participants across 232 sites in 24 countries.

Signals

Enrolling ahead of pace

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Cancer
CountriesAustralia, 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, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 3Recruiting
202420252026202720282029
First PostedJan 12, 2024
Enrollment StartMay 21, 2024
Primary CompletionApr 30, 2027
Study CompletionFeb 22, 2029
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 2.5 years agoPrimary completion in 10 months

Arms & Interventions

Ifinatamab deruxtecan (I-DXd)experimental

Participants randomized to receive 12 mg/kg I-DXd monotherapy on Day 1 of each 21-day cycle until unacceptable toxicity, progressive disease (PD), or withdrawal of consent as specified in the protocol.

Drug: Ifinatamab deruxtecan
Treatment of Physician's Choice (TPC)active_comparator

Participants randomized to receive topotecan, lurbinectedin, or amrubicin, as per investigator's choice and per locally approved label (indicated dose and frequency), until a treatment discontinuation criterion is met as specified in the protocol.

Drug: TopotecanDrug: AmrubicinDrug: Lurbinectedin

Interventions

Ifinatamab deruxtecandrug

12 mg/kg intravenous dose on Day 1 of each 21-day cycle

Topotecandrug

Topotecan will be administered per local SoC.

Amrubicindrug

Amrubicin will be administered per local SoC.

Lurbinectedindrug

Lurbinectedin will be administered per local SoC