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

• 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 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.

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: 2025-09-17
• Last Update Posted: 2025-09-22

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 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.

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 (23)

University of Colorado Anschutz School of Medicine; 🇺🇸 Aurora, Colorado, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, South Korea

National Cheng Kung University Hospital; 🇨🇳 Tainan City, Taiwan

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

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

Royal North Shore Hospital; 🇦🇺 St Leonards, New South Wales, Australia

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

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