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

Sponsor: Daiichi Sankyo

Expanded Access
Sponsor score: 40
Inactive

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.

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