Status: Recruiting
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
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).
Participants needed: 450
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Nuvalent Inc.Updated: Jul 13, 2026Locations: 156
Eligibility criteria
Histologically or cytologically confirmed locally advanced (not amenable for mul... [+4]
Patient's cancer has a known oncogenic driver alteration other than ALK. [+9]