Study of NVL-330 for HER2-altered NSCLC
This study is testing a new oral tablet called NVL-330 for people with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific change in the HER2 gene. Researchers want to find the safest and most effective dose of NVL-330. They will also look at how well NVL-330 works against the cancer. To join, you must be at least 18 years old and have NSCLC with a documented HER2 alteration. The study aims to enroll about 200 participants. The study is currently recruiting, but the exact status is unclear.
- Study design
- This is a Phase 1a/1b study, which means it's an early-stage trial to test safety and find the right dose. It is designed to enroll a set number of participants per dose level.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for at least 30 days after your last dose of NVL-330.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
At a glance
Conditions
Where it's being run
21 sites across 17 statesStudy leadership
- Steve Margossian, MD PhD · STUDY_DIRECTOR · Nuvalent Inc.
Who to contact
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What this trial measures
- Recommended Phase 2 Dose (RP2D)As determined by incidence of DLTs during the first 28 days of treatment (ie, Cycle 1)
To determine up to 2 RP2D Candidates
- Maximum Tolerated Dose (MTD)As determined by incidence of DLTs during the first 28 days of treatment (ie, Cycle 1)
If applicable, to determine the MTD
- Incidence and severity of Treatment Emergent Adverse Events (TEAEs)First dose of study drug through 30 days after the last dose of study drug
Number of participants with TEAEs as assessed by CTCAE, v5.0