NCT06765109

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Nuvalent Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Patients will be randomized in a 1:1 ratio (approximately 225 in each arm) to receive either neladalkib (NVL-655) or alectinib.

Conditions

• Non-small Cell Lung Cancer
• Anaplastic Lymphoma Kinase-positive

Interventions

Type	Name	Description
DRUG	Neladalkib (NVL-655)	Oral tablet of Neladalkib (NVL-655)
DRUG	Alectinib	Oral capsule of alectinib

Timeline

• Start date: 2025-07-17
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2025-01-09
• Last updated: 2026-03-24

Locations

137 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study