Expanded Access Program of Zidesamtinib (NVL-520) for Patients with Advanced ROS1+ NSCLC (NVL-520-EAP)
Sponsor: Nuvalent Inc.
ClinicalTrials ID:NCT06797362
This Expanded Access Program provides zidesamtinib (NVL-520) to eligible patients with ROS1+ advanced NSCLC who have received at least one prior ROS1 TKI and lack other treatment options. Eligibility includes age ≥18, confirmed ROS1 rearrangement, and adequate organ function. The intervention involves an oral tablet form of NVL-520. Enrollment in a clinical trial is not possible for these patients.
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Program Overview
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.
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC with documented ROS1 rearrangement
- Previously received at least 1 prior ROS1 TKI, with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.
- Enrollment in a clinical trial of zidesamtinib is not possible.
- Adequate organ function and bone marrow reserve.
Exclusion Criteria
- Prior receipt of zidesamtinib.
- Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.
- Ongoing anti-cancer therapy.
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