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Evaluating NVL-330 for advanced HER2-altered lung cancer

A Phase 1a/1b Study of the Selective Tyrosine Kinase Inhibitor NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)

Phase 1 Interventional Nuvalent Inc. · NCT06521554

This study is testing a new treatment called NVL-330 to see if it can safely help people with advanced lung cancer that has changes in the HER2 gene.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorNuvalent Inc. Industry-sponsored
Locations21 sites (Irvine, California and 20 other locations)
Trial IDNCT06521554 on ClinicalTrials.gov

What this trial studies

This is a Phase 1a/1b clinical trial designed to assess the safety, tolerability, and antitumor activity of NVL-330 in patients with advanced or metastatic HER2-altered non-small cell lung cancer (NSCLC). The trial consists of a dose escalation phase to determine the recommended Phase 2 dose (RP2D) and an expansion phase to further evaluate the safety and efficacy of the selected dose. Patients will be monitored for safety and disease response according to established criteria.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed advanced or metastatic HER2-altered NSCLC who have evaluable or measurable disease.

Not a fit: Patients with known oncogenic driver alterations other than HER2 or those currently receiving other anticancer therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced HER2-altered NSCLC.

How similar studies have performed: While this approach is novel in targeting HER2 alterations in NSCLC, similar studies have shown promise in other cancers with HER2 mutations.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥ 18 years
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC
3. Documented HER2 status as follows:

   1. Phase 1a: Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations or single nucleotide variants or HER2 amplification.
   2. Phase 1b: Documented oncogenic HER2 mutation.
4. Identification of lesions as follows:

   1. Phase 1a: Must have evaluable disease (target or nontarget) according to RECIST 1.1.
   2. Phase 1b: Must have measurable disease, defined as ≥ 1 radiologically measurable target lesion according to RECIST 1.1.
5. Adequate organ function and bone marrow reserve

Exclusion Criteria:

1. Participant's cancer has known oncogenic driver alteration other than HER2
2. Known allergy/hypersensitivity to excipients of NVL-330
3. Major surgery within 4 weeks of the first dose of study drug
4. Ongoing or recent anticancer therapy
5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study

Where this trial is running

Irvine, California and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.