Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
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.
Checked against the public recordLast updated Aug 6, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Expanded Access
- Phase
- Not applicable
- Sponsor
- Nuvalent Inc.
- Interventions being studied
- Drug: NVL-655
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University Of California Irvine Medical CenterOrange, California
- University of Colorado Anschutz School of MedicineAurora, Colorado
- University of Chicago Medical CenterChicago, Illinois
- Massachusetts General HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Henry Ford Cancer InstituteDetroit, Michigan
- Washington University in St. LouisSt Louis, Missouri
- NYU Langone HealthNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Duke UniversityDurham, North Carolina
- The Ohio State UniversityColumbus, Ohio
- The University of Texas MD Anderson Cancer CenterHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 6, 2026. Always confirm current availability with the study team.