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drugset / Trial / NCT06765109

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

NCT06765109 ↗

Phase 3 Recruiting 450 enrolled Nuvalent Inc.
RandomizedParallel-groupSingle-blindTreatment

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).

Timeline

Start
2025-07-17
Primary completion
2029-12
Completion
2029-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alectinib Small molecule 600 mg Oral
Subject Neladalkib Small molecule 150 mg Oral

Indications

non-small cell lung carcinoma