Medical Access Program for Datopotamab Deruxtecan in Patients with Advanced Non-Small Cell Lung Cancer

Sponsor: Daiichi Sankyo

Expanded Access
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06279728

Provider View

This program provides access to a new treatment, Dato-DXd, for patients with advanced non-small cell lung cancer (NSCLC) who have already tried other treatments and have no other options. It is for those who cannot join a clinical trial and need a new treatment approach.

Patient Parameters

Program Overview

The Medical Access Program aims to offer the drug Dato-DXd to patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have already received treatment but still need help. This program is for patients who cannot benefit from existing treatments and are not eligible for clinical trials. It allows them to access Dato-DXd until certain conditions occur, such as disease progression, unacceptable side effects, or if the drug becomes commercially available.

Description

This program is designed for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have no other treatment options and cannot join a clinical trial. Patients can continue receiving Dato-DXd until one of the following happens: the cancer worsens, side effects become too severe, the treatment no longer benefits the patient, the drug becomes available for purchase, the patient decides to stop, consent is withdrawn, pregnancy occurs, the doctor advises stopping, or the patient passes away.

Participants can choose to share safety information about their treatment experience, which will help improve understanding of Dato-DXd. This is optional and does not affect their treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation.
  • Cancer has worsened after the most recent treatment.
  • Have received specific prior treatments:
    • Without certain gene changes: must have had platinum-based chemotherapy and PD-(L)1 therapy.
    • With certain gene changes: must have had at least one targeted therapy and platinum-based chemotherapy.
  • Have good bone marrow and organ function.
  • Women of childbearing age must have a negative pregnancy test before starting treatment.
  • Agree to use effective birth control during and after the program (7 months for women, 4 months for men).
  • Men must not donate sperm, and women must not donate eggs during and after the program.
  • Have a life expectancy of more than 3 months.
  • Willing to provide written consent to participate.

Exclusion Criteria

  • History of lung inflammation (ILD/pneumonitis) requiring steroids or current lung inflammation.
  • Severe lung issues from other illnesses, such as recent blood clots, severe asthma, or lung disease.
  • Unresolved severe side effects from previous cancer treatments.
  • Active or uncontrolled hepatitis B or C infection.
  • Uncontrolled HIV infection.
  • Severe allergic reactions to Dato-DXd or similar drugs.
  • Pregnant or breastfeeding women.
  • Any medical condition that could make Dato-DXd unsafe.
  • Significant eye disease.
  • Currently in another clinical study or eligible for one.
  • Previous treatment with certain cancer drugs.
  • Recent radiation therapy to the brain or chest.

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