NCT06797362

Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors

Expanded Access Treatment of Zidesamtinib (NVL-520) in Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Nuvalent Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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) or eligible patients with other ROS1-positive solid tumors who have previously received any prior commercially-available or investigational therapy, and lack satisfactory therapeutic alternatives and are unable to access zidesamtinib through a clinical trial.

Conditions

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

Interventions

Type	Name	Description
DRUG	NVL-520	Oral tablet

Timeline

• First posted: 2025-01-28
• Last updated: 2026-02-17

Locations

35 sites across 10 countries: United States, Australia, Canada, France, Italy, Netherlands, Singapore, Spain, Taiwan, United Kingdom