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

N

Nuvalent

Status

Conditions

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

Treatments

Drug: NVL-520

Study type

Expanded Access

Funder types

Industry

Identifiers

NCT06797362
NVL-520-EAP

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

7

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Central trial contact

Contact for Program Information

Data sourced from clinicaltrials.gov

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