Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 30, 2026
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Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06765109). This is a study registration, not published results. Lead sponsor: Nuvalent Inc.. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 450 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive. Interventions: DRUG: Neladalkib (NVL-655); DRUG: Alectinib. Primary outcome measures: Progression-free survival (PFS) per blinded independent central review (BICR) , Up to 5 years after first patient dosed. 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).