A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1) (NCT05384626)
A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
🩺 Plain-English Summary (8th-Grade Level)
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of neladalkib (NVL-655), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will evaluate the overall safety and tolerability of neladalkib and will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of neladalkib in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of neladalkib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of neladalkib in patients with advanced ALK-positive NSCLC and other solid tumors. A drug-drug interaction (DDI) sub-study will determine the effect of neladalkib on the pharmacokinetics of midazolam and repaglinide, as well as the effect of itraconazole on the pharmacokinetics of neladalkib, in patients with advanced ALK-positive NSCLC
Who can join: Review the eligibility criteria below.
Location: University of California Irvine Medical Center — Orange, California
Age range: 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (74 Sites)
Showing the first 25 of 74 sites.
- University of California Irvine Medical Center — Orange, California
- University of California, Davis Comprehensive Cancer Center — Sacramento, California
- Stanford Cancer Institute — Stanford, California
- University of Colorado Cancer Center — Aurora, Colorado
- Georgetown University Medical Center — Washington D.C., District of Columbia
- University of Miami; Sylvester Cancer Center — Miami, Florida
- Winship Cancer Institute, Emory University — Atlanta, Georgia
- University of Chicago Medical Center — Chicago, Illinois
- John Hopkins University — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts
- Henry Ford Cancer Institute — Detroit, Michigan
- Washington University School of Medicine Siteman Cancer Center — St Louis, Missouri
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Duke University Medical Center — Durham, North Carolina
- OSU Brain & Spine Hospital — Columbus, Ohio
- University of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania
- Sarah Cannon — Nashville, Tennessee
- MD Anderson Cancer Center — Houston, Texas
- Fred Hutchinson Cancer Center — Seattle, Washington
- Royal North Shore Hospital — Sydney, New South Wales
- Princess Alexandra Hospital — Woolloongabba, Queensland
- Peter MacCallum Cancer Centre — Melbourne, Victoria
- Universitair Ziekenhuis Antwerpen (UZA) — Antwerp,
📞 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.