NVL-330 for Advanced HER2-altered Lung Cancer
A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
Recruiting
Phase 1
Interventional Study
Locally Advanced Solid Tumor
Metastatic Solid Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Nuvalent Inc. · Industry
Who this trial is looking for
This trial is looking for adults with non-small cell lung cancer that has a specific change in the HER2 gene. Participants will receive a study drug called NVL-330 to see how well it works and its safety.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old.
- I have been diagnosed with non-small cell lung cancer.
- My cancer has a HER2 mutation.
- I have tumors that can be measured.
- My organs are functioning well.
You may not be able to join if
- I have a different cancer gene change other than HER2.
- I am allergic to any ingredients in NVL-330.
- I have had major surgery in the last 4 weeks.
- I have received cancer treatment recently.
- I am currently in another clinical trial.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 …
Trial Locations
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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 amplificati…
Contacts