A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1) (NCT06521554)
A Phase 1a/1b Study of the Selective Tyrosine Kinase Inhibitor NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
🩺 Plain-English Summary (8th-Grade Level)
Phase 1a/1b dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-330, determine the recommended Phase 2 dose (RP2D), and evaluate the antitumor activity in participants with advanced or metastatic human epidermal growth factor receptor 2 (HER2) -altered non-small lung cancer (NSCLC). Phase 1a dose escalation is designed to assess the safety and tolerability of NVL-330 and to select the candidate RP2D(s) and, if applicable, the MTD. Phase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2D(s) of NVL-330 and to determine the RP2D of NVL-330 in participants with advanced or metastatic HER2 mutant NSCLC.
Who can join: Review the eligibility criteria below.
Location: City of Hope - Lennar — Irvine, California
Age range: 18 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 (21 Sites)
- City of Hope - Lennar — Irvine, California
- University of California, Davis Comprehensive Cancer Center — Sacramento, California
- Stanford Cancer Institute — Stanford, California
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado
- Georgetown University Medical Center — Washington D.C., District of Columbia
- Sibley Memorial Hospital — Washington D.C., District of Columbia
- Sylvester Comprehensive Cancer Center — Miami, Florida
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bayview Medical Center — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- Henry Ford Cancer Center — Detroit, Michigan
- Washington University — St Louis, Missouri
- Memorial Sloan Kettering Cancer Center — New York, New York
- OSU Brain and Spine Hospital — Columbus, Ohio
- SCRI Oncology Partners — Nashville, Tennessee
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- NEXT Virginia — Fairfax, Virginia
- Fred Hutchinson Cancer Center — Seattle, Washington
- Chris O'Brien Lifehouse — Camperdown, New South Wales
- North Shore Health Hub — Saint Leonards, New South Wales
- Cross Cancer Institute — Edmonton, Alberta
- Princess Margaret Cancer Center - University Health Network — Toronto, Ontario
📞 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.