Naucalpan De Juarez

Researchers are evaluating treatments for people with advanced non-small cell lung cancer NSCLC that have specific genetic changes called HER2 mutations. This lung cancer has spread or cannot be controlled with current treatments. The study aims to compare how well a drug called sevabertinib works and how safe it is compared to standard treatment for this type of cancer. Participants will receive either sevabertinib tablets twice daily or standard treatment consisting of pembrolizumab combined with platinum-based chemotherapy given every 21 days by infusion. Those on standard treatment who experience disease progression may switch to sevabertinib. Treatment continues as long as participants benefit and do not have severe side effects or until they or their doctor decide to stop. During the study, participants will have imaging scans like CT, PET, MRI, and X-rays to monitor cancer spread. Doctors will also perform health checks including blood and urine tests, heart monitoring with ECG, pregnancy tests for women, and ask about symptoms or side effects. The main measure is progression-free survival assessed up to about 2 years, with additional outcomes related to survival, response rates, side effects, and quality of life followed up to 4 years.

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.