NCT06834074

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

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

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Nuvalent Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	NVL-655	Drug: NVL-655

Timeline

• First posted: 2025-02-19
• Last updated: 2026-04-07

Locations

43 sites across 12 countries: United States, Australia, Canada, France, Italy, Netherlands, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom