Phase 1 study

Recruiting Phase 1

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 1
Sponsor Nuvalent Inc.
Registry number NCT06521554
Started 18 July 2024 Today 16 October 2026 Estimated completion 1 January 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Chris O'Brien Lifehouse Camperdown NSW Recruiting
North Shore Health Hub Saint Leonards NSW Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 200

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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

Dates on the record

Started 18 July 2024
Estimated completion 1 January 2027
Registry last updated 25 February 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 25 February 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.