This study is not accepting new patients

Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors

a study on Lung Cancer Non-Small Cell Lung Cancer ALK Positive Solid Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started

Description

Summary

The Expanded Access Program will provide an alternate mechanism for patients, who lack satisfactory therapeutic alternatives and cannot participate in a neladalkib clinical trial, to access investigational neladalkib.

Official Title

Expanded Access Treatment of Neladalkib (NVL-655) in Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors

Details

The purpose of this Expanded Access Program is to provide investigational ALK inhibitor, neladalkib (NVL-655), for eligible patients with ALK-positive locally advanced or metastatic NSCLC (ALK+ NSCLC) who have previously received an ALK tyrosine kinase inhibitor (TKI) or eligible patients with other ALK-positive solid tumors, and lack satisfactory therapeutic alternatives and are unable to access neladalkib through a clinical trial.

Keywords

Non Small Cell Lung Cancer, ALK-positive Non-small Cell Lung Cancer (NSCLC), ALK-positive Solid Tumors, Non-Small-Cell Lung Carcinoma, NVL-655

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age ≥18 years.
  2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumors with a documented ALK rearrangement or activating ALK mutation.
  3. Previously received at least one ALK TKI (for patients with NSCLC) or any prior therapy (for patients with other solid tumors), with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.
  4. Enrollment in a clinical trial of neladalkib is not possible.
  5. Adequate organ function and bone marrow reserve.

You CAN'T join if...

  1. Prior receipt of neladalkib.
  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.

Locations

  • University Of California Irvine Medical Center not accepting new patients
    Orange California 92868 United States
  • University of Colorado Anschutz School of Medicine not accepting new patients
    Aurora Colorado 80045 United States

Details

Status
not accepting new patients
Start Date
Sponsor
Nuvalent Inc.
ID
NCT06834074
Study Type
Expanded Access
Last Updated
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