Actively Recruiting
A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan I-DXd, a B7-H3 Antibody Drug Conjugate, Versus Treatment of Physicians Choice in Subjects With Relapsed Small Cell Lung Cancer
Led by Daiichi Sankyo · Updated on 2026-06-02
540
Participants Needed
232
Research Sites
94 weeks
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Ifinatamab Deruxtecan I-DXd compared with treatments chosen by physicians for adults with relapsed extensive-stage small cell lung cancer SCLC. This Phase 3 randomized study aims to see if I-DXd can improve objective response rates and prolong overall survival compared to other standard treatments. The study also examines other factors such as patient-reported outcomes, immunogenicity, B7-H3 protein expression, and pharmacokinetics of I-DXd. Participants are randomly assigned to one of two groups. One group receives I-DXd at a dose of 12 mgkg intravenously on Day 1 of each 21-day cycle until unacceptable side effects, disease progression, or withdrawal. The other group receives one of three treatmentstopotecan, lurbinectedin, or amrubicinbased on the doctors choice and local guidelines, continuing until treatment criteria for stopping are met. No placebo is used, and the study is open-label. During the study, participants will have tumor assessments and survival monitored up to about five years. Evaluations include measuring tumor response by independent review and investigators, progression-free survival, duration of response, quality of life questionnaires, safety monitoring for adverse events, and tests of drug levels in the blood. Participants will be followed for disease progression, treatment effects, and survival throughout the study period, which may last several years.
CONDITIONS
Brief Title
A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Adults aged 18 years or older at consent
- Histologically or cytologically confirmed extensive-stage small cell lung cancer
- Adequate baseline tumor tissue sample available
- Received only one prior platinum-based systemic therapy for SCLC with at least 2 cycles and a chemotherapy-free interval of 30 days or more
- At least one measurable lesion per RECIST v1.1
- Radiological disease progression after most recent systemic therapy
- Eastern Cooperative Oncology Group performance status of 0 or 1 within 7 days before treatment start
- No evidence of brain or leptomeningeal disease and stable neurological status without steroids or anticonvulsants for at least 2 weeks before first dose
You will not qualify if you...
- Prior treatment with B7-H3 targeted agents including I-DXd
- Prior discontinuation of an antibody drug conjugate containing an exatecan derivative due to toxicity
- Previous use of any study comparator drugs or topoisomerase I inhibitors
- Inadequate washout period before randomization
- History of cerebrovascular accident, transient ischemic attack, or arterial thromboembolic event within past 6 months
- Uncontrolled or significant cardiovascular disease
- Clinically significant corneal disease
- History or evidence of interstitial lung disease or pneumonitis not related to radiation
- Severe pulmonary compromise from other lung illnesses or prior lung surgery requiring supplemental oxygen
Research Team
D
Daiichi Sankyo Contact for Clinical Trial Information
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