RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 patients with advanced or metastatic HER2-altered 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 patients with advanced or metastatic HER2 mutant NSCLC.

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)

Quick Facts

Study Start:2024-07-18
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06521554

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 years
  2. 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC
  3. 3. Documented HER2 status as follows:
  4. 1. Phase 1a: Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations or single nucleotide variants or HER2 amplification.
  5. 2. Phase 1b: Documented oncogenic HER2 mutation.
  6. 4. Identification of lesions as follows:
  7. 1. Phase 1a: Must have evaluable disease (target or nontarget) according to RECIST 1.1.
  8. 2. Phase 1b: Must have measurable disease, defined as ≥ 1 radiologically measurable target lesion according to RECIST 1.1.
  9. 5. Adequate organ function and bone marrow reserve
  1. 1. Patient's cancer has known oncogenic driver alteration other than HER2
  2. 2. Known allergy/hypersensitivity to excipients of NVL-330
  3. 3. Major surgery within 4 weeks of the first dose of study drug
  4. 4. Ongoing or recent anticancer therapy
  5. 5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study

Contacts and Locations

Study Contact

Lisa Morelli
CONTACT
857-357-7000
clinicaltrials@nuvalent.com

Principal Investigator

Steve Margossian, MD PhD
STUDY_DIRECTOR
Nuvalent Inc.

Study Locations (Sites)

City of Hope - Lennar
Irvine, California, 92618
United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
Stanford Cancer Institute
Stanford, California, 94305
United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
United States
Georgetown University Medical Center
Washington, District of Columbia, 20007
United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Henry Ford Cancer Center
Detroit, Michigan, 48242
United States
Washington University
Saint Louis, Missouri, 63110
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
OSU Brain and Spine Hospital
Columbus, Ohio, 43210
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
NEXT Virginia
Fairfax, Virginia, 22031
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Nuvalent Inc.

  • Steve Margossian, MD PhD, STUDY_DIRECTOR, Nuvalent Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-18
Study Completion Date2026-03

Study Record Updates

Study Start Date2024-07-18
Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

  • Locally Advanced Solid Tumor
  • Metastatic Solid Tumor