Naucalpan De Juarez

Researchers are investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.

Researchers are evaluating neladalkib (NVL-655) compared to alectinib in patients with treatment-naefve, ALK-positive advanced Non-Small Cell Lung Cancer (NSCLC). This Phase 3, multicenter, randomized, controlled, open-label study aims to show that neladalkib can prolong progression-free survival (PFS) better than alectinib in this patient group. Patients included have advanced or metastatic NSCLC confirmed to have ALK rearrangement and have not received prior systemic anticancer treatments for NSCLC. Participants will be randomly assigned in a 1:1 ratio to receive either oral neladalkib tablets or oral alectinib capsules. Each group will have approximately 225 patients. Treatment will be given as first-line therapy without prior ALK tyrosine kinase inhibitor use. The study monitors the patients over time to compare the effectiveness of these two drugs in controlling the disease. During the study, researchers will assess progression-free survival up to 5 years after the first patient is dosed, using blinded independent central review. Patients will have measurable disease and provide pretreatment tumor tissue for evaluation. Safety monitoring includes tracking heart rhythm, infections, and other health conditions. The study excludes patients with certain infections, recent major surgery, or other active cancers requiring therapy. This comprehensive follow-up aims to evaluate how well each treatment controls cancer progression and its safety over time.