OncoMatch/Clinical Trials/NCT05384626
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Is NCT05384626 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including Neladalkib (NVL-655) and Midazolam for locally advanced solid tumor.
Treatment: Neladalkib (NVL-655) · Midazolam · Repaglinide · Itraconazole — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK activating mutation
Required: ALK rearrangement
Demographics
Prior therapy
Must have received: ALK inhibitor
Must have previously received ≥1 ALK TKI
Cannot have received: investigational agent targeting ALK
no prior investigational agents targeting ALK
Lab requirements
Blood counts
bone marrow reserve
Kidney function
Liver function
Adequate organ function and bone marrow reserve
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Irvine Medical Center · Orange, California
- University of California, Davis Comprehensive Cancer Center · Sacramento, California
- Stanford Cancer Institute · Stanford, California
- University of Colorado Cancer Center · Aurora, Colorado
- Georgetown University Medical Center · Washington D.C., District of Columbia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05384626 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational agent targeting ALK disqualifies patients from enrollment.
Does this trial require ALK?
Yes, ALK activating mutation is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK rearrangement is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 60 years or younger and at least 12 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages