clinical trial · NCT06765109
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Non-small Cell Lung CancerAnaplastic Lymphoma Kinase-positiveNeladalkib (NVL-655)Alectinib
brief summary
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).
started
Jul 17, 2025
primary completion
Dec 1, 2029
completion
Dec 1, 2029
last updated
Mar 24, 2026
detailed description
Patients will be randomized in a 1:1 ratio (approximately 225 in each arm) to receive either neladalkib (NVL-655) or alectinib.
official title
A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol