West Mackay

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 effectiveness and safety of induction therapy with Afimkibart (RO7790121) compared to a placebo in people with moderately to severely active ulcerative colitis (UC). This Phase III, multicenter, double-blind, placebo-controlled study focuses on participants aged 16 to 80 who have an established diagnosis of UC and have shown inadequate response or intolerance to previous UC treatments. Participants will receive either Afimkibart or a matching placebo. Those assigned to the Afimkibart group will get the drug first through an intravenous (IV) infusion, followed by subcutaneous (under the skin) injections. The placebo group will receive matching IV and subcutaneous treatments that do not contain the active drug. During the study, participants will be monitored for clinical remission at 12 weeks, which is the primary outcome measure. Researchers will assess safety and response through scheduled visits and evaluations. The study includes careful tracking of participants' health status and any side effects to understand the treatment's impact over the course of the trial.

Researchers are evaluating the efficacy and safety of induction therapy with Afimkibart (also called RO7790121) in people aged 16 to 80 years who have moderately to severely active Crohn's disease. This Phase III, multicenter, double-blind, placebo-controlled study focuses on how well Afimkibart works compared to placebo in improving symptoms and healing the intestine. Participants will receive Afimkibart either as an intravenous (IV) infusion or a subcutaneous (SC) injection. The study includes a placebo group receiving a matching IV infusion. Treatment is given during the induction phase to assess the initial response. During the study, participants will be monitored for clinical remission using the Crohn's Disease Activity Index and for endoscopic response at 12 weeks. Researchers will assess safety, effectiveness, and any side effects throughout the study. Participants will undergo evaluations including symptom tracking and medical tests to measure treatment outcomes.

Researchers are evaluating the safety and effectiveness of a drug called HB-1 compared to placebo and two other medications in adults aged 18 to 65 years diagnosed with Panic Disorder. This phase 2, multicenter, randomized, double-blind, placebo-controlled trial aims to include approximately 240 to 600 participants, including those with or without certain co-existing conditions, to better understand treatment options for Panic Disorder. Participants will be randomly assigned to receive HB-1, telmisartan, verapamil, or a matched placebo, all provided as tablets. The treatment period lasts 12 weeks, after which a safety follow-up visit will occur one week after the last dose. Throughout the study, patients and researchers will not know which treatment the participants receive to ensure unbiased results. During the trial, participants will be monitored regularly for the number of unexpected panic attacks and any side effects that may arise, with assessments occurring weekly during treatment and at follow-up. Safety evaluations, including laboratory tests and questionnaires, will be conducted at specific intervals to track participants' health and treatment effects throughout the study duration.

Researchers are evaluating the long-term effects of lidocaine infusions given during and after surgery on the development of moderate or severe chronic post-surgical pain (CPSP) one year after breast cancer surgery in adult female patients. This Phase 3, international, randomized, double-blind, placebo-controlled trial involves more than 4,000 participants undergoing mastectomy or breast conserving surgery. The study aims to detect a 25% reduction in CPSP incidence and also assesses safety, pain relief effectiveness, neuropathic pain characteristics, psychological well-being, and quality of life. Participants receive either a lidocaine infusion or a placebo infusion starting with an intravenous bolus after anesthesia induction, followed by continuous intravenous infusion during surgery. After surgery, a subcutaneous lidocaine or placebo infusion is continued for up to 24 hours. Dosages are based on lean body weight and capped at 68 kg. Patients undergoing day-case surgery receive only the intraoperative bolus and infusion without the postoperative infusion. Throughout the study, patient pain levels, opioid use, safety events, neuropathic pain symptoms, psychological status, and quality of life are closely monitored. The primary outcome is the patient-reported incidence of moderate or severe CPSP one year after surgery. Data collection includes follow-up visits and assessments to track both short-term and long-term effects of the treatments.

This research aims to evaluate whether lowering blood phosphate levels in people with end-stage kidney disease (ESKD) who are on dialysis can reduce the risk of death or major heart-related events compared to maintaining higher phosphate levels. The study also looks at whether lowering phosphate improves physical health, fatigue, quality of life, patient satisfaction, and itching, as well as whether it is cost-effective. Hyperphosphatemia, or high phosphate in the blood, is common in ESKD and linked to higher death risk, but there is no strong trial evidence that lowering phosphate improves important patient outcomes. Participants will be randomly assigned to one of two groups: an intensive phosphate target group aiming to keep serum phosphate at or below 1.50 mmol/L using phosphate-lowering medications, or a liberal phosphate target group aiming for a higher phosphate range of 2.0 to 2.5 mmol/L. In the liberal group, all phosphate-lowering drugs at baseline will be stopped and only restarted if phosphate rises above 2.5 mmol/L. Medication choice and doses will be based on physicians' and participants' decisions to meet target levels. The trial is multinational and will include 3600 adults on dialysis. During the study, researchers will track major outcomes including cardiovascular death or serious heart and artery events over 5 years. They will also assess physical health, quality of life using the EQ5D-5L questionnaire, fatigue, itching, and overall survival. The study involves monitoring serum phosphate levels and medication use, and measuring cost-effectiveness of the treatment strategies. Participants will be followed closely to understand the safety and impact of the phosphate targets on their health and well-being.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.