Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC (NCT06765109)
A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (11 items).
Location: Palo Verde Hematology Oncology — Glendale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patient's cancer has a known oncogenic driver alteration other than ALK.
- Known allergy/hypersensitivity to excipients of neladalkib or alectinib.
- Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization
- Major surgery within 4 weeks prior to randomization
- Uncontrolled clinically relevant infection requiring systemic therapy
- Known active tuberculosis, or active Hepatitis B or C
- QT corrected for heart rate by Fridericia's formula (QTcF) \> 470 msec on repeated assessments
- Clinically significant cardiovascular disease
- Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease
- Active malignancy requiring therapy within 2 years prior to randomization
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (158 Sites)
Showing the first 25 of 158 sites.
- Palo Verde Hematology Oncology — Glendale, Arizona
- Hoag Hospital Newport Beach — Newport Beach, California
- University of California, Irvine Health — Orange, California
- Rocky Mountain Cancer Centers — Boulder, Colorado
- Sylvester Comprehensive Cancer Center Miami — Miami, Florida
- AdventHealth Cancer Institute — Orlando, Florida
- H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida
- Winship Cancer Institute of Emory University — Atlanta, Georgia
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan
- Washington University Center for Advanced Medicine — St Louis, Missouri
- NYU Langone's Perlmutter Cancer Center — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Optum Medical Care, PC — Westbury, New York
- Carolinas Medical Center — Charlotte, North Carolina
- Duke Cancer Center — Durham, North Carolina
- University of Cincinnati Cancer Center — Cincinnati, Ohio
- The Ohio State University — Columbus, Ohio
- Alliance Cancer Specialists — Sellersville, Pennsylvania
- SCRI Oncology Partners — Nashville, Tennessee
- Virginia Cancer Specialists — Fairfax, Virginia
- University of Washington - Fred Hutchinson Cancer Center — Seattle, Washington
- Compass Oncology — Vancouver, Washington
- Sanatorio Parque S.A. — Rosario, Santa Fe Province
- Sanatorio Allende — Córdoba,
📞 Contact the Study Coordinator
Phone: (857) 357-7000
Email: clinicaltrials@nuvalent.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.