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

Nuvalent

Status

Conditions: ALK-positive Non-small Cell Lung Cancer (NSCLC); Non Small Cell Lung Cancer

Treatments: Drug: NVL-655

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT06834074

NVL-655-EAP

Details and patient eligibility

About

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.

Full 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.

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 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.