Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lung Cancer
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorDaiichi Sankyo
About this trial
The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to I-DXd for eligible patients with extensive-stage small cell lung cancer (ES-SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen), and for eligible patients who have no suitable treatment options and are not able to enter a clinical study.
Eligibility criteria
Qualifiers
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.
Disqualifiers
The Patient is eligible for other treatment options or can enroll in an open clinical trial with patients with pre-treated ES-SCLC.
The patient has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
The patient has been discontinued from an ADC that consists of an exatecan derivative (e.g., trastuzumab deruxtecan) due to treatment-related toxicities.
The patient has had an inadequate washout period before randomization as defined in the protocol.
Trial design
Treatments tested in this trial
- Ifinatamab Deruxtecan
Treatment groups
No treatment groups listed
Sponsors and collaborators
Daiichi Sankyo
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov