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A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
NCT06521554 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG NVL-330
Study Locations (20)
California
- City of Hope - Lennar — Irvine
- University of California, Davis Comprehensive Cancer Center — Sacramento
- Stanford Cancer Institute — Stanford
District of Columbia
- Georgetown University Medical Center — Washington D.C.
- Sibley Memorial Hospital — Washington D.C.
New South Wales
- Chris O'Brien Lifehouse — Camperdown
- North Shore Health Hub — Saint Leonards
Colorado
- Sarah Cannon Research Institute at HealthONE — Denver
Florida
- Sylvester Comprehensive Cancer Center — Miami
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bayview Medical Center — Baltimore
Massachusetts
- Massachusetts General Hospital — Boston
Michigan
- Henry Ford Cancer Center — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-07-18 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06521554
The ClinicalTrials.gov registry entry for NCT06521554 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nuvalent, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Metastatic Solid Tumor appearing as the primary indexed condition, and to 1 intervention — of which NVL-330 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06521554 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, District of Columbia, New South Wales. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06521554 about?
NCT06521554 is a clinical study titled "A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)". 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-sma...
What is the current status of trial NCT06521554?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2024-07-18. Estimated completion is 2027-02.
What conditions does trial NCT06521554 study?
This clinical trial studies the following conditions: Metastatic Solid Tumor, Locally Advanced Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06521554?
The interventions under investigation include: NVL-330 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06521554?
This trial is sponsored by Nuvalent, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06521554 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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