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NCT07535359AVAILABLE

Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lung Cancer

Medical Access Program for Ifinatamab Deruxtecan (I-DXd, DS-7300a)

Sponsor: Daiichi Sankyo + Merck Sharp & Dohme LLC

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Key Facts

Study type
EXPANDED_ACCESS
Conditions
SCLC, Extensive-stage Small Cell Lung Cancer
Interventions
Ifinatamab Deruxtecan
Enrollment
Primary completion
Study completion
First posted
Apr 2026
Last updated
May 2026

Eligibility Criteria

Patients are only eligible after signing the informed consent form and must meet all of the following criteria to be eligible for the Medical Access Program. Inclusion Criteria: * The patient has at least one SCLC lesion that has not been previously irradiated. * The patient is aged ≥18 years or older. * The patient has histologically or cytologically documented ES-SCLC. * The patient had prior therapy with platinum-based chemotherapy and one additional treatment as systemic therapy for extensive-stage disease. * The patient has received prior treatment with a minimum of two previous lines of systemic therapy. * The patient has a documented radiological disease progression on or after the most recent systemic therapy. * The patient has an ECOG PS of 0-1. * The patient has a life expectancy of ≥3 months * The patient has adequate organ and bone marrow function as defined in the protocol within 7 days prior to Cycle 1 Day 1 of I-DXd treatment. Transfusion (red blood cell or platelet) o

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✦ Analyst Commentary

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Source

Open on ClinicalTrials.gov