Expanded Access Program for Zidesamtinib (NVL-520) in Patients with Advanced ROS1+ Non-Small Cell Lung Cancer

Sponsor: Nuvalent Inc.

Expanded Access
Sponsor score: 60

ClinicalTrials ID:NCT06797362

Provider View

This program allows patients with advanced ROS1+ non-small cell lung cancer, who have no other treatment options and cannot join a clinical trial, to access the investigational drug zidesamtinib.

Patient Parameters

Program Overview

The Expanded Access Program is designed to provide the investigational drug zidesamtinib (NVL-520) to patients with advanced non-small cell lung cancer (NSCLC) that is positive for ROS1 fusion. This is for patients who have already tried at least one ROS1 tyrosine kinase inhibitor (TKI) and have no other satisfactory treatment options available. It is specifically for those who cannot participate in a clinical trial for zidesamtinib.

Description

This program aims to make the investigational drug zidesamtinib available to patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change known as ROS1 fusion. These patients must have already been treated with at least one ROS1 tyrosine kinase inhibitor (TKI) and have no other good treatment options left. The program is for those who cannot join a clinical trial for zidesamtinib, providing them with another way to access this potential treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a ROS1 genetic change.
  • Have previously tried at least one ROS1 tyrosine kinase inhibitor (TKI) and have no other good treatment options, as determined by your doctor.
  • Cannot join a clinical trial for zidesamtinib.
  • Have adequate organ function and bone marrow health.

Exclusion Criteria

  • Have previously received zidesamtinib.
  • Have had recent surgery, chemotherapy, radiation, or other cancer treatments, or participated in other studies within a specific timeframe.
  • Are currently receiving any other cancer treatment.

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