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

ClinicalTrials.gov ID: NCT06521554

Public ClinicalTrials.gov record NCT06521554. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 3, 2026, 9:50 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1a/1b Study of the Selective Tyrosine Kinase Inhibitor NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 of NVL-330 and to select the candidate RP2D(s) and, if applicable, the MTD. Phase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2D(s) of NVL-330 and to determine the RP2D of NVL-330 in participants with advanced or metastatic HER2 mutant NSCLC.

Study identification

NCT ID: NCT06521554
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Nuvalent Inc.; Industry
Enrollment: 200 participants

Conditions and interventions

Conditions

Interventions

NVL-330 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 18, 2024 (Actual)
Primary completion: Jan 2027 (Estimated)
Completion: Feb 2027 (Estimated)
Last update posted: Feb 25, 2026

2024 – 2027

United States locations

U.S. sites: 17
U.S. states: 14
U.S. cities: 16

Facility	City	State	ZIP	Site status
City of Hope - Lennar	Irvine	California	92618	Recruiting
University of California, Davis Comprehensive Cancer Center	Sacramento	California	95817	Recruiting
Stanford Cancer Institute	Stanford	California	94305	Recruiting
Sarah Cannon Research Institute at HealthONE	Denver	Colorado	80218	Recruiting
Georgetown University Medical Center	Washington D.C.	District of Columbia	20007	Recruiting
Sibley Memorial Hospital	Washington D.C.	District of Columbia	20016	Recruiting
Sylvester Comprehensive Cancer Center	Miami	Florida	33136	Recruiting
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bayview Medical Center	Baltimore	Maryland	21224	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
Henry Ford Cancer Center	Detroit	Michigan	48242	Recruiting
Washington University	St Louis	Missouri	63110	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Recruiting
OSU Brain and Spine Hospital	Columbus	Ohio	43210	Recruiting
SCRI Oncology Partners	Nashville	Tennessee	37203	Recruiting
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
NEXT Virginia	Fairfax	Virginia	22031	Recruiting
Fred Hutchinson Cancer Center	Seattle	Washington	98109	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06521554, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 25, 2026 · Synced Oct 3, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06521554 live on ClinicalTrials.gov.

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