Clinical Trials Directory

Trials / Temporarily Not Available

Temporarily Not AvailableNCT07535359

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)

Status
Temporarily Not Available
Phase
Study type
Expanded Access
Enrollment
Sponsor
Daiichi Sankyo · Industry
Sex
All
Age
18 Years
Healthy volunteers

Summary

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.

Detailed description

A patient enrolled in this MAP can continue treatment until any of the following occurs (whichever comes first): * Disease progression. * Unacceptable toxicity. * The benefit-risk no longer favors the individual. * I-DXd becomes commercially available in the US, and reimbursement is approved for the treatment of ES-SCLC. * The patient chooses to discontinue treatment. * Withdrawal of consent. * Pregnancy. * Physician discretion. * Death.

Conditions

Interventions

TypeNameDescription
DRUGIfinatamab Deruxtecan12 mg/kg intravenous infusion Q3W (on Day 1 of each 21-day cycle)

Timeline

First posted
2026-04-17
Last updated
2026-04-17

Source: ClinicalTrials.gov record NCT07535359. Inclusion in this directory is not an endorsement.