Nuvalent Inc., a clinical-stage biopharmaceutical company, has announced the initiation of the ALKAZAR Phase 3 randomized, controlled trial. This global study is evaluating the efficacy of neladalkib for TKI-naïve patients with advanced ALK-positive non-small cell lung cancer (NSCLC), comparing it to ALECENSA® (alectinib), a current front-line standard of care. The trial aims to enroll approximately 450 patients, with a primary focus on progression-free survival based on Blinded Independent Central Review. Secondary endpoints include overall survival and various measures of intracranial response and safety. Results from this trial have not yet been presented and will be awaited in the future.
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