Evaluating NVL-330 for advanced HER2-altered lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• City of Hope - Lennar
  Irvine, California, United States Recruiting
• University of California, Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• Stanford Cancer Institute
  Stanford, California, United States Recruiting
• Sarah Cannon Research Institute at HealthONE
  Denver, Colorado, United States Recruiting
• Georgetown University Medical Center
  Washington D.C., District of Columbia, United States Recruiting
• Sibley Memorial Hospital
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Study coordinator: Lisa Morelli
• Email: clinicaltrials@nuvalent.com
• Phone: 857-357-7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.