Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06765109 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

NCT06765109 · ClinicalTrials.gov record · last posted 2026-08-25

Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

Name: Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC — clinical trial record (NCT06765109)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: ALKAZAR

StatusRecruiting

PhasePhase 3

SponsorNuvalent Inc.

Started2025-07-17

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).

Protocol amendment history 2 changes detected by DataLookout

2026-05-15

Trial sites expanded: 149 → 153 locations

2026-05-06

Trial sites expanded: 137 → 149 locations

Trial Details

NCT Number	NCT06765109
Lead Sponsor	Nuvalent Inc.
Conditions	Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive
Enrollment	450 participants
Start Date	2025-07-17
Primary Completion	2029-12 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-25