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Clinical Trial ● Currently Recruiting Phase III NCT06203210

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

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician’s Choice in Subjects With Relapsed Small Cell Lung Cancer — Recruiting • Phase III • Oncology • NCT06203210.

📅 02 Jun 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT06203210
Sponsor
Daiichi Sankyo
Start
2024-05-21
ClinicaliQ Trial Snapshot
  • A Study of Ifinatamab Deruxtecan Versus Treatment of Physician’s Choice in Subjects With Relapsed Small Cell Lung Cancer — Recruiting • Phase III • Oncology • NCT06203210.
  • What is being tested: Ifinatamab deruxtecan (I-DXd), a novel antibody-drug conjugate targeting DLL3, is being compared against standard physician-selected chemotherapy in patients with relapsed small cell lung cancer.
  • Patient eligibility overview: The trial includes patients with small cell lung cancer that has recurred after initial treatment, representing a population with limited therapeutic options and historically poor outcomes.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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).

Eligibility Snapshot
  • Participants must meet all the following criteria to be eligible for randomization into the study: 1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
  • Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed. 3. Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC). 4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content. 5. Has received prior therapy with only one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy and a chemotherapy free-interval of ≥30 days. 6. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator. 7. Has documentation of radiological disease progression on or after the most recent systemic therapy. 8. Has ECOG PS of ≤1 within 7 days prior to Cycle 1 Day 1 (C1D1). 9. Has no evidence of brain or leptomeningeal disease (spinal cord or central nervous system [CNS] metastases) based on history and physical examination. Subjects must require no treatment with steroids or anticonvulsants and have a stable neurologic…

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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