Shiso

Researchers are studying the effectiveness of neladalkib NVL-655 compared to alectinib in patients with advanced Non-Small Cell Lung Cancer NSCLC that tests positive for Anaplastic Lymphoma Kinase ALK and who have not received prior treatment. This Phase 3 trial aims to determine if neladalkib can better prolong the time patients live without disease progression. The study involves patients with advanced or metastatic ALK-positive NSCLC and is sponsored by Nuvalent Inc. Participants will be randomly assigned to one of two groups one group will take neladalkib 150 mg orally once daily, and the other will take alectinib 600 mg orally twice daily. Both treatments are given as oral pills, and the study compares these two drugs directly. Patients will be followed for up to 5 years after starting treatment to assess outcomes. During the trial, patients will undergo regular assessments including tumor measurements based on RECIST 1.1 criteria, brain imaging to monitor intracranial progression, and laboratory tests. Researchers will monitor progression-free survival, overall survival, response rates, duration of response, adverse events, and patient-reported quality of life and lung cancer symptoms. The study will last until December 2029, with close follow-up to evaluate long-term effects and safety.