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
Locations
3Central Care Cancer Center67401, SalinaKansas, United States
Duke Cancer Institute27710, DurhamNorth Carolina, United States
University of Texas Southwestern Medical75390, DallasTexas, United States
Sponsors and collaborators
Daiichi Sankyo
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov