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NCT06797362 · ClinicalTrials.gov record · last posted 2026-08-25

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

Name: Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors — clinical trial record (NCT06797362)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusAvailable

PhaseNot specified

SponsorNuvalent Inc.

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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. Following FDA Approval of zidesamtinib on 22 July 2026, the Expanded Access Program is closed in the United States (US); however, it remains open at all non-US sites listed on ClinicalTrials.gov.

Protocol amendment history 1 change detected by DataLookout

2026-08-26

Trial sites reduced: 37 → 30 locations

Trial Details

NCT Number	NCT06797362
Lead Sponsor	Nuvalent Inc.
Conditions	Non Small Cell Lung Cancer, ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
Updated on ClinicalTrials.gov	2026-08-25