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

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

• Registration Number: NCT06834074
• Lead Sponsor: Nuvalent Inc.

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-19
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (12)

Kantonsspital Luzern; 🇨🇭 Lucerne, Switzerland

GCS IUCT Oncopole; 🇫🇷 Toulouse, Occitanie, France

Institut Gustave Roussy; 🇫🇷 Villejuif, Île-de-France, France

Stichting Het Nederlands Kanker Instituut; 🇳🇱 Amsterdam, North Holland, Netherlands

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

BC Cancer - Vancouver; 🇨🇦 Vancouver, British Columbia, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Centre Leon Berard; 🇫🇷 Lyon, Auvergne-Rhône-Alpes, France

CHU de Nantes; 🇫🇷 Nantes, Pays De La Loire, France

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore