ClinicalTrials.gov record
Recruiting Phase 1Phase 2 Interventional

A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

ClinicalTrials.gov ID: NCT05384626

Public ClinicalTrials.gov record NCT05384626. 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.

ClinicalTrials.gov public records Last synced May 11, 2026, 4:39 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 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)

Study identification

NCT ID
NCT05384626
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Nuvalent Inc.
Industry
Enrollment
840 participants

Conditions and interventions

Interventions

  • Neladalkib (NVL-655) Drug

Drug

Eligibility (public fields only)

Age range
12 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
Jun 8, 2022
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027
Last update posted
Oct 29, 2025

2022 – 2028

United States locations

U.S. sites
21
U.S. states
17
U.S. cities
19
Facility City State ZIP Site status
University of California Irvine Medical Center Orange California 92868 Recruiting
University of California, Davis Comprehensive Cancer Center Sacramento California 95817 Recruiting
Stanford Cancer Institute Stanford California 94305 Recruiting
University of Colorado Cancer Center Aurora Colorado 80045 Recruiting
Georgetown University Medical Center Washington D.C. District of Columbia 20007 Recruiting
University of Miami; Sylvester Cancer Center Miami Florida 33136 Recruiting
Winship Cancer Institute, Emory University Atlanta Georgia 30322 Recruiting
University of Chicago Medical Center Chicago Illinois 60637 Recruiting
John Hopkins University Baltimore Maryland 21224 Recruiting
Massachusetts General Hospital Boston Massachusetts 02114 Recruiting
Dana Farber Cancer Institute Boston Massachusetts 02215 Recruiting
Henry Ford Cancer Institute Detroit Michigan 48202 Recruiting
Washington University School of Medicine Siteman Cancer Center St Louis Missouri 63310 Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health New York New York 10016 Recruiting
Memorial Sloan Kettering Cancer Center New York New York 10065 Recruiting
Duke University Medical Center Durham North Carolina 27705 Recruiting
OSU Brain & Spine Hospital Columbus Ohio 43210 Recruiting
University of Pennsylvania, Abramson Cancer Center Philadelphia Pennsylvania 19104 Recruiting
Sarah Cannon Nashville Tennessee 37203 Recruiting
MD Anderson Cancer Center Houston Texas 77030 Active, not 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 53 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05384626, 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 Oct 29, 2025 · Synced May 11, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05384626 live on ClinicalTrials.gov.

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