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Researchers are evaluating the safety, tolerability, and effects of ORX750 in adults with Narcolepsy Type 1 NT1, Narcolepsy Type 2 NT2, and Idiopathic Hypersomnia IH. These rare conditions cause excessive daytime sleepiness and affect daily activities such as school, work, and driving. The study aims to understand how ORX750, which mimics the brain protein orexin that helps maintain wakefulness, impacts sleepiness and other symptoms in these conditions. Participants will receive either ORX750 capsules or matching placebo capsules in a randomized, double-blind setup. The study assesses multiple groups those with NT1, NT2, and IH. The treatment and monitoring will occur over a period of up to 35 days, including evaluation of plasma drug levels and sleepiness measures. During the study, participants will undergo safety assessments including monitoring for adverse events, laboratory tests, vital signs, ECGs, and suicidal ideation screening up to day 35. Researchers will also measure sleepiness using the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. The total study duration for each participant is about five weeks, with careful observation of how the body processes ORX750 and its effects on daytime alertness.

Researchers are evaluating the HER2DX diagnostic assay in patients with early-stage HER2-positive breast cancer to improve how treatment decisions are made. This international phase III study compares quality of life, safety, effectiveness, and economic impact between patients receiving standard care and those receiving treatment personalized by HER2DX test results. The study focuses on patients with stage II to IIIA disease eligible for neoadjuvant therapy. Participants are randomly assigned to one of two groups Arm A receives treatment chosen by their doctor without knowledge of HER2DX test results, following standard guidelines. Arm B receives personalized treatment based on HER2DX molecular diagnosis, which classifies patients into high-risk or low-risk groups with specific chemotherapy and antibody regimens before and after surgery. Treatments include paclitaxel, trastuzumab, pertuzumab, carboplatin, docetaxel, T-DM1, or no adjuvant therapy depending on risk and response. During the study, participants undergo assessments including quality of life questionnaires EORTC QLQ-C30 and FACIT Fatigue Scale, cancer response evaluations, safety monitoring, and economic analyses for up to five years. Researchers will measure outcomes such as survival, cancer recurrence, adverse events, work productivity, and patient-reported health status. Participants will have surgery after neoadjuvant treatment and regular follow-ups to monitor their health and treatment effects throughout the study period.

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, randomized, open-label study aims to see if daraxonrasib can improve progression-free survival or overall survival in patients who have already received prior treatments. The study focuses on patients with locally advanced or metastatic NSCLC who cannot be cured with surgery or radiation. Participants will be randomly assigned in equal groups to receive either daraxonrasib tablets or docetaxel by intravenous infusion. The treatments will be given according to the study plan, and participants will be monitored over about four years. The study includes careful assessment of response to treatment, safety, quality of life, and drug characteristics during this period. During the trial, participants will undergo regular evaluations including imaging scans to measure tumor size, assessments of side effects, blood tests to check organ function, and questionnaires about quality of life. Researchers will track how long patients live without disease progression and overall survival, along with treatment effects and tolerability. This follow-up and monitoring will continue for up to approximately four years, ensuring comprehensive data collection throughout the study duration.