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NCT05384626 · ClinicalTrials.gov record · last posted 2026-05-27

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

StatusRecruiting
PhasePhase 1/2
Started2022-06-09
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from the ClinicalTrials.gov record
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

Amendment record 50 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 50 times since 2022-05-17; most recent amendment 2026-05-22. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2022-05-23
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT05384626
Lead Sponsor Nuvalent Inc.
Conditions Locally Advanced Solid Tumor, Metastatic Solid Tumor
Enrollment 840 participants
Start Date 2022-06-09
Primary Completion 2027-12 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-27