Actively Recruiting
A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
Led by Nuvalent Inc. · Updated on 2026-02-25
200
Participants Needed
21
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC)
- Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations, single nucleotide variants, or HER2 amplification (Phase 1a)
- Documented oncogenic HER2 mutation (Phase 1b)
- Evaluable disease according to RECIST 1.1 (Phase 1a)
- Measurable disease with at least one radiologically measurable target lesion according to RECIST 1.1 (Phase 1b)
- Adequate organ function and bone marrow reserve
You will not qualify if you...
- Cancer with known oncogenic driver alteration other than HER2
- Known allergy or hypersensitivity to excipients of NVL-330
- Major surgery within 4 weeks before the first dose of study drug
- Ongoing or recent anticancer therapy
- Currently receiving systemic treatment or direct medical intervention on another therapeutic clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
City of Hope - Lennar
Irvine, California, United States, 92618
Actively Recruiting
2
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
3
Stanford Cancer Institute
Stanford, California, United States, 94305
Actively Recruiting
4
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
5
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
6
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
7
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
8
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
9
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
10
Henry Ford Cancer Center
Detroit, Michigan, United States, 48242
Actively Recruiting
11
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
12
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
13
OSU Brain and Spine Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
14
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
17
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
18
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, NSW 2050
Actively Recruiting
19
North Shore Health Hub
Saint Leonards, New South Wales, Australia, 2065
Actively Recruiting
20
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
21
Princess Margaret Cancer Center - University Health Network
Toronto, Ontario, Canada, M5G 1L7
Actively Recruiting
Research Team
L
Lisa Morelli
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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