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.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 12:32 PM EDT

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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)

Brief summary

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

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of neladalkib (NVL-655), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will evaluate the overall safety and tolerability of neladalkib and will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of neladalkib in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of neladalkib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of neladalkib in patients with advanced ALK-positive NSCLC and other solid tumors. A drug-drug interaction (DDI) sub-study will determine the effect of neladalkib on the pharmacokinetics of midazolam and repaglinide, as well as the effect of itraconazole on the pharmacokinetics of neladalkib, in patients with advanced ALK-positive NSCLC

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

Conditions

Interventions

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: May 26, 2026

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 May 26, 2026 · Synced Sep 5, 2026

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