A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)

Launched by NUVALENT INC. · Jul 25, 2024

Keywords

ClinConnect Summary

The HEROEX-1 clinical trial is testing a new medication called NVL-330 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) that have a specific change in the HER2 gene. This study aims to find out how safe NVL-330 is, determine the best dose to use in future studies, and see how well it works to fight cancer. The trial has two parts: the first part will gradually increase the dose to find a safe level, while the second part will focus on a specific dose that seems to be safe and effective.

To join the trial, participants need to be at least 18 years old and have confirmed advanced or metastatic NSCLC with a documented HER2 mutation. They should also have measurable cancer that can be evaluated through scans. It's important to note that patients with certain other cancer treatments or conditions may not be eligible. Those who participate can expect regular check-ups to monitor their health and the cancer's response to the treatment. This trial is currently recruiting patients, and it presents an opportunity for individuals with this type of lung cancer to access new treatment options.

Gender

ALL

Eligibility 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. Patient'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