Expanded Access Program for Zipalertinib in Advanced Non-Small Cell Lung Cancer

Sponsor: Taiho Oncology, Inc.

Expanded Access
Sponsor score: 40

ClinicalTrials ID:NCT07601399

Provider View

This program provides access to the drug zipalertinib for patients with advanced non-small cell lung cancer (NSCLC) who have specific genetic mutations and have not responded to standard treatments.

Patient Parameters

Program Overview

The goal of this program is to offer the drug zipalertinib to patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation called EGFR exon 20 insertion. This is for patients whose cancer has worsened after receiving platinum-based chemotherapy, with or without another drug called amivantamab. Only licensed doctors can inquire about this program, and patients should discuss participation with their physician.

Description

This program allows patients with advanced NSCLC, who have specific genetic mutations and have tried all standard treatments, to receive zipalertinib. Patients must be new to zipalertinib and need it for their treatment. Enrollment is done through the MyAccess Programs Platform.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Have advanced or recurrent NSCLC with a specific genetic mutation (EGFR exon 20 insertion) confirmed by a certified lab.
  • Have tumors that can be measured or not measured.
  • Cancer must have worsened after platinum-based chemotherapy, with or without amivantamab.
  • Must have tried all standard treatments or cannot tolerate them.
  • Must be in good general health with an ECOG performance status of 0 or 1.
  • Must have good organ function.
  • Women who can become pregnant must have a negative pregnancy test before starting zipalertinib.
  • Both men and women must agree to use effective birth control during and for one week after the program.
  • Must be able to take oral medications (no feeding tubes allowed).

Exclusion Criteria

  • Have a history or current evidence of lung disease or serious heart problems.
  • Have used zipalertinib before.
  • Have not recovered from side effects of previous cancer treatments, except for certain mild conditions.
  • Have had recent radiation therapy, immunotherapy, or major surgery.
  • Have a serious illness or condition that makes participation inappropriate.
  • Have another primary cancer that could interfere with the safety assessment of zipalertinib.
  • Have an allergy to zipalertinib or similar drugs.
  • Are pregnant, breastfeeding, or planning to become pregnant.

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