Achim

Researchers are evaluating the safety and effectiveness of a new oral drug called daraxonrasib compared to the chemotherapy drug docetaxel in patients with non-small cell lung cancer (NSCLC) that has a specific RAS mutation. This Phase 3 global study focuses on patients whose cancer has locally advanced or spread and who have already received prior treatments. The goal is to see if daraxonrasib can improve the time patients live without their cancer worsening and overall survival. Participants will be randomly assigned to receive either daraxonrasib tablets taken by mouth or docetaxel given by intravenous infusion. The study is open-label, meaning both doctors and patients know which treatment is given. Treatment continues as long as it is appropriate, and patients are monitored throughout the study period. During the trial, patients will undergo regular assessments to measure disease progression and survival up to about four years. Researchers will evaluate progression-free survival and overall survival as the main outcomes. Patients must have measurable disease and meet health criteria, and their RAS mutation status will be confirmed. Safety and effectiveness will be closely monitored throughout the study.

Researchers are evaluating the effectiveness and safety of oral tinengotinib compared to the physician's choice of treatment in people with cholangiocarcinoma that has genetic changes in the fibroblast growth factor receptor (FGFR). This study focuses on patients whose cancer has returned or not responded after chemotherapy and prior FGFR inhibitor treatment. It is a global, Phase III, randomized, controlled trial involving about 200 participants. Participants will be randomly assigned to different treatment groups. In Part A, they will receive either tinengotinib at 8 mg or 10 mg once daily by mouth in 28-day cycles, or the physician's choice treatment. For those in the physician's choice group receiving FOLFOX or FOLFIRI chemotherapy, treatment is given every two weeks with two doses per 28-day cycle. In Part B, eligible participants will be randomized to receive either the recommended dose of tinengotinib or the selected dose, or physician's choice treatment. Throughout the study, participants will be monitored for side effects up to 30 days after stopping treatment. Researchers will also assess progression-free survival, which means the length of time during and after treatment that the cancer does not worsen, for up to 24 months. The study includes regular evaluations to track safety and treatment effects, with all treatments self-administered or given as scheduled by the doctor. The study aims to provide important information on how well tinengotinib works compared to other treatments in this patient population.