Zhubei City

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating the safety, tolerability, and effectiveness of baxdrostat compared to a placebo in reducing seated blood pressure and normalizing the Renin Angiotensin Aldosterone System (RAAS) in adults aged 18 years and older diagnosed with Primary Aldosteronism (PA). This Phase III, multicenter, randomized, double-blind, placebo-controlled study aims to include about 180 participants, some of whom may have prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. Participants will be randomly assigned to receive either baxdrostat tablets or matching placebo tablets once daily. The dose may be increased after two weeks depending on clinical response and tolerability. The study is conducted in approximately 90 centers across 12 countries, providing a broad and diverse participant base. During the study, researchers will closely monitor seated systolic blood pressure and RAAS normalization at week 8 to assess the treatment effects. Participants will also undergo laboratory tests including serum potassium and sodium levels, kidney function evaluation, and blood pressure measurements. Safety and tolerability will be assessed throughout the study period, ensuring comprehensive monitoring of participants' health and response to treatment.

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are studying patients with recurrent or metastatic head and neck cancers, including squamous cell carcinoma of the oropharynx, oral cavity, hypopharynx, or larynx, to understand the prognostic value of circulating tumor emboli (CTM) and the tumor microenvironment. The study aims to link circulating tumor cells (CTC), CTM, and natural killer (NK) cells within CTM to patient outcomes and treatment effectiveness. This work is especially relevant in Taiwan, where a unique type of head and neck cancer associated with betel nut use exists, and current methods lack the ability to assess CTM clusters or immune environment in detail. The study uses a microfluidic liquid biopsy platform called the DS-SACA chip to analyze blood samples from patients receiving treatment prescribed by their primary care doctors. Investigators will examine the numbers and characteristics of CTCs and CTM, as well as NK cell interferon-gamma expression within CTM. These analyses will be correlated with clinical factors such as HPV status, smoking, betel nut use, treatment methods, and patient prognosis to better predict disease progression and recurrence. Participants will provide blood samples for analysis during their regular treatment. Researchers will collect medical records and monitor progression-free survival up to 60 months. The study assesses how CTM and immune components change with different treatments and how these changes relate to patient outcomes. This observational approach aims to improve understanding of tumor metastasis and guide future therapeutic strategies.

Researchers are evaluating the safety and effectiveness of NH002-enhanced echocardiography in adults with cardiac diseases who have suboptimal echocardiograms. This Phase 3, prospective, open-label, multicenter study focuses on how well NH002 can improve the visibility of the left ventricular chamber and the clarity of the left ventricular endocardial border compared to standard echocardiography without contrast. The study also monitors the safety and tolerability of NH002 as a contrast agent. NH002 is a microbubble injectable suspension given through an intravenous line after an activation process. Participants receive NH002 during echocardiography to enhance the imaging of the heart. The study compares images taken before and within 10 minutes after NH002 injection to assess improvements in left ventricular visualization. There is no mention of additional treatment groups or phases beyond this evaluation. Participants will undergo echocardiograms with and without NH002 to collect image data for measuring left ventricular endocardial border delineation and left ventricular opacification. Researchers will review these images to determine the effect of NH002 on heart imaging quality. The study involves screening, NH002 administration, imaging within a short timeframe post-injection, and safety monitoring to evaluate any side effects or issues. Total participation duration details are not specified.

Researchers are evaluating the safety and effectiveness of a drug called PF-07220060 combined with letrozole compared to other approved treatments (palbociclib, ribociclib, or abemaciclib with letrozole) in adults with breast cancer that is hormone receptor-positive and HER2-negative. This cancer has spread locally or to other parts of the body and has not been treated with systemic anti-cancer therapy for advanced or metastatic disease. The study is a Phase 3, open-label, randomized trial involving multiple centers. Participants will be randomly assigned to receive either PF-07220060 plus letrozole or the investigator's choice of one of the approved CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) combined with letrozole. The treatments are given as drugs with letrozole serving as endocrine therapy. The study compares these treatments in terms of how well they control the cancer and their safety profiles. Participants will visit the study clinic regularly for monitoring during treatment. Researchers will assess how long participants live without their disease worsening or dying from any cause, which is the main outcome measured up to about four years. The study team will monitor each participant's health and response to treatment through these visits to gather information about treatment effects and safety.