Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
NCT06765109
This study is recruiting at 22 US sites in 14 states, according to its ClinicalTrials.gov record last updated .
Summary
Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Non-small Cell Lung Cancer
- Anaplastic Lymphoma Kinase-positive
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Nuvalent Inc.
- Last updated on ClinicalTrials.gov
- September 30, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arizona · 1
- Palo Verde Hematology Oncology · Glendale, AZ
California · 2
- Hoag Hospital Newport Beach · Newport Beach, CA
- University of California, Irvine Health · Orange, CA
Colorado · 1
- Rocky Mountain Cancer Centers · Boulder, CO
Florida · 3
- Sylvester Comprehensive Cancer Center Miami · Miami, FL
- AdventHealth Cancer Institute · Orlando, FL
- H Lee Moffitt Cancer Center and Research Institute · Tampa, FL
Georgia · 1
- Winship Cancer Institute of Emory University · Atlanta, GA
Massachusetts · 1
- Dana-Farber Cancer Institute · Boston, MA
Missouri · 1
- Washington University Center for Advanced Medicine · St Louis, MO
New York · 3
- Memorial Sloan Kettering Cancer Center · New York, NY
- NYU Langone's Perlmutter Cancer Center · New York, NY
- Optum Medical Care, PC · Westbury, NY
North Carolina · 2
- Carolinas Medical Center · Charlotte, NC
- Duke Cancer Center · Durham, NC
Ohio · 2
- University of Cincinnati Cancer Center · Cincinnati, OH
- The Ohio State University · Columbus, OH
Pennsylvania · 1
- Alliance Cancer Specialists · Sellersville, PA
Tennessee · 1
- SCRI Oncology Partners · Nashville, TN
Virginia · 1
- Virginia Cancer Specialists · Fairfax, VA
Washington · 2
- University of Washington - Fred Hutchinson Cancer Center · Seattle, WA
- Compass Oncology · Vancouver, WA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.