Expanded Access Program of Neladalkib (NVL-655) for Patients with Advanced ALK+ NSCLC

Sponsor: Nuvalent Inc.

Expanded Access
Sponsor score: 60

ClinicalTrials ID:NCT06834074

This Expanded Access Program offers the investigational ALK inhibitor, neladalkib (NVL-655), to eligible patients with ALK+ NSCLC who have previously received lorlatinib or a second-generation ALK TKI. Participants must be ≥18 years, have advanced NSCLC with ALK rearrangement, and lack satisfactory treatment alternatives. Adequate organ function and bone marrow reserve are required.

Patient Parameters

Program Overview

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.

Description

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 lorlatinib or a second-generation ALK tyrosine kinase inhibitor (TKI) and lack satisfactory therapeutic alternatives and are unable to access neladalkib through a clinical trial.

Eligibility Criteria

Inclusion Criteria

  1. Age ≥18 years.
  2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement or activating ALK mutation.
  3. Previously received lorlatinib or received at least one second-generation ALK TKI and is either not eligible for or does not have access to lorlatinib, 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.

Exclusion Criteria

  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.

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