Medical Access Program for Ifinatamab Deruxtecan in Patients with Advanced Small Cell Lung Cancer

Sponsor: Daiichi Sankyo

Expanded Access
Sponsor score: 40

ClinicalTrials ID:NCT07535359

Provider View

This program provides access to the drug Ifinatamab Deruxtecan for patients with extensive-stage small cell lung cancer who have already tried at least two treatments, including one platinum-based therapy, and have no other suitable treatment options.

Patient Parameters

Program Overview

The Medical Access Program aims to offer the drug Ifinatamab Deruxtecan (I-DXd) to patients with extensive-stage small cell lung cancer (ES-SCLC) who have undergone two or more previous treatments and have no other treatment options available. This program is designed for patients who cannot participate in a clinical trial and need access to this medication.

Description

Patients in this program can continue receiving the treatment until one of the following occurs:

  • The cancer progresses.
  • Side effects become unacceptable.
  • The treatment's risks outweigh the benefits.
  • The drug becomes available commercially and is covered by insurance.
  • The patient decides to stop treatment.
  • The patient withdraws consent.
  • The patient becomes pregnant.
  • The doctor decides to stop treatment.
  • The patient passes away.

Eligibility Criteria

Inclusion Criteria

  • Have at least one small cell lung cancer lesion that hasn't been treated with radiation.
  • Be 18 years or older.
  • Have a confirmed diagnosis of extensive-stage small cell lung cancer.
  • Have previously received platinum-based chemotherapy and at least one other treatment for extensive-stage disease.
  • Have tried at least two different systemic therapies.
  • Show disease progression on or after the last treatment.
  • Have a performance status score of 0-1, indicating good overall health.
  • Have a life expectancy of at least 3 months.
  • Have adequate organ and bone marrow function as per the study's requirements.
  • Agree to use effective contraception during and after the program (8 months for women, 5 months for men).
  • Women must have a negative pregnancy test before joining.
  • Women agree not to donate eggs during and for 8 months after the program.
  • Men agree not to donate sperm during and for 5 months after the program.

Exclusion Criteria

  • Eligible for other treatments or clinical trials for pre-treated ES-SCLC.
  • Previously treated with specific drugs targeting B7-H3, including I-DXd.
  • Stopped treatment with a similar drug due to side effects.
  • Did not have enough time between treatments as required by the study.
  • Have untreated or symptomatic brain metastases or spinal cord issues.
  • Had a stroke or similar event in the past 6 months.
  • Have significant eye disease.
  • Have uncontrolled heart disease.
  • Have a history of lung inflammation or current lung issues.
  • Have severe lung problems from other illnesses.
  • Are on high-dose steroids, except for certain conditions.
  • Have had a bone marrow or organ transplant.
  • Have unresolved side effects from previous cancer treatments.
  • Have severe allergies to the study drug or similar medications.
  • Have an ongoing uncontrolled infection.
  • Have active hepatitis B or C.
  • Have an autoimmune disease, with some exceptions.
  • Have severe or uncontrolled health issues that make participation unsafe.
  • Have received a live vaccine recently.
  • Are pregnant, breastfeeding, or planning to become pregnant.
  • Have uncontrolled HIV infection.
  • Have active hepatitis B or C, unless under control with treatment.

Locations

FACILITYZIPCITYSTATE
Central Care Cancer Center67401SalinaKansas
Duke Cancer Institute27710DurhamNorth Carolina
University of Texas Southwestern Medical75390DallasTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.