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

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.
• Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).
• The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
• 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.
• Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
• Has documentation of radiological disease progression on or after the most recent systemic therapy.
• Has ECOG PS of ≤1 within 7 days prior to Cycle 1 Day 1 (C1D1).
• 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 status for at least 2 weeks prior to the first dose of study drug.

🚫 You may not be able to join if…

• Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd.
• Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
• Has received any of the comparators used in this study or any topoisomerase I inhibitor.
• Has inadequate washout period before randomization as specified in the protocol.
• Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
• Has uncontrolled or significant cardiovascular disease.
• Has clinically significant corneal disease.
• Has any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids. Examples of suspected ILD/pneumonitis by imaging include the presence of lung parenchymal fibrosis, such as combined pulmonary fibrosis and emphysema (CPFE) and any radiographic features consistent with ILA, including but not limited to, extensive ground glass opacities, reticular opacities, traction bronchiectasis, and honeycombing.
• Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders, prior pneumonectomy, or requirement for supplemental oxygen.

Where this trial is running

• Highlands Oncology Group, Springdale, Arkansas, United States
• Clinical Research Providence Medical Foundation, Fullerton, California, United States
• UCLA Hematology-Oncology, Los Angeles, California, United States
• UCSF Mission Bay Mission Hall, San Francisco, California, United States
• University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center, Miami, Florida, United States
• AdventHealth Orlando, Cancer Institute, Orlando, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute, Inc, Tampa, Florida, United States
• Rush MD Anderson Cancer Center, Chicago, Illinois, United States
• Baptist Health Lexington, Lexington, Kentucky, United States
• University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
• John Hopkins School of Medicine, Baltimore, Maryland, United States
• Dana-Farber Cancer Institute, Boston, Massachusetts, United States

+ 220 more sites.

Who to contact

Daiichi Sankyo Contact for Clinical Trial Information · 9089926400 · CTRinfo@dsi.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06203210.