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

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.

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.

Inclusion Criteria: 1. Age ≥18 years. 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumor 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. 4. Eligible for ongoing clinical trial with zidesamtinib