Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC (NVL-520-EAP)

• Conditions: Non Small Cell Lung Cancer; ROS1-positive Non-Small Cell Lung Cancer (NSCLC)

• Registration Number: NCT06797362
• Lead Sponsor: Nuvalent Inc.

Brief Summary

The Expanded Access Program will provide an alternate mechanism for these patients, who lack satisfactory therapeutic alternatives and cannot participate in a zidesamtinib clinical trial, to access investigational zidesamtinib.

Detailed Description

The purpose of this Expanded Access Program is to provide access to zidesamtinib (NVL-520) an investigational therapy for eligible patients with ROS1 fusion-positive advanced non- small cell lung cancer (ROS1+ NSCLC) who have previously received ≥ 1 prior ROS1 tyrosine kinase inhibitor (TKI) and lack satisfactory therapeutic alternatives and are unable to access zidesamtinib through a clinical trial.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-28
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age ≥18 years.
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC with documented ROS1 rearrangement
3. Previously received at least 1 prior ROS1 TKI, with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.
4. Enrollment in a clinical trial of zidesamtinib is not possible.
5. Adequate organ function and bone marrow reserve.

Exclusion Criteria

1. Prior receipt of zidesamtinib.
2. Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.
3. Ongoing anti-cancer therapy.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (9)

Centre Leon Berard; 🇫🇷 Lyon, Auvergne-Rhône-Alpes, France

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Chris O'Brien Lifehouse; 🇦🇺 Camperdown, New South Wales, Australia

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Institut Gustave Roussy; 🇫🇷 Villejuif, Île-de-France, France

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore

The Royal Marsden Hospital; 🇬🇧 Sutton, Surrey, United Kingdom