Northfield

Researchers are evaluating the effects of Dato-DXd combined with osimertinib or Dato-DXd alone compared to platinum-based doublet chemotherapy in people with EGFR-mutated locally advanced or metastatic non-small cell lung cancer NSCLC whose disease progressed after prior osimertinib treatment. This Phase III, open-label, randomized study aims to compare progression-free survival among these treatments to better understand options for this condition. Participants are randomly assigned to one of three groups Dato-DXd plus osimertinib, Dato-DXd alone, or platinum-based doublet chemotherapy. Dato-DXd is given as an intravenous infusion every 3 weeks, osimertinib is taken orally daily, and chemotherapy involves pemetrexed combined with carboplatin or cisplatin every 3 weeks for four cycles, followed by maintenance pemetrexed. Treatments continue until disease progression, unacceptable side effects, or other reasons to stop. Throughout the study, participants undergo regular assessments including radiological scans to monitor tumor response using RECIST v1.1 criteria, safety evaluations, and health status measurements. After stopping treatment, an end-of-treatment visit occurs within 35 days, followed by safety follow-up 28 days after the last dose. The study primarily measures progression-free survival over up to 2.5 years, with additional outcomes including overall survival, response rates, quality of life, and pharmacokinetics monitored for up to 3.5 years.

Researchers are evaluating the safety and effectiveness of tezepelumab in children aged 5 to under 12 years with severe uncontrolled asthma. These children are already on medium to high doses of inhaled corticosteroids and at least one other asthma controller medication. The study is a phase 3, randomized, double-blind, placebo-controlled trial aimed at assessing tezepelumabs impact on asthma control and safety in this pediatric population. Participants will be randomly assigned in a 21 ratio to receive either subcutaneous injections of tezepelumab or a matching placebo over a 52-week double-blind treatment period. Before this, there is a 4 to 6 week screening and run-in period. After the treatment phase, there is a 12-week off-treatment follow-up for those not continuing. Additionally, an optional 104-week open-label extension allows eligible participants to receive tezepelumab, followed by another 12-week post-treatment follow-up. Throughout the study, participants will undergo regular assessments including lung function tests, asthma control questionnaires, symptom diaries, and blood tests to measure inflammation and immune response. Researchers will monitor asthma exacerbations, medication use, quality of life, and any side effects. Safety will be tracked during treatment and follow-up periods, with total study involvement potentially lasting over three years for those in the extension phase.

This research aims to compare the effects of two inhalers, budesonidealbuterol metered-dose inhaler BDA MDI and albuterol sulfate metered-dose inhaler AS MDI, both used as needed, in adolescents aged 12 to 17 years with asthma. The study focuses on their impact on the annual rate of severe asthma attacks in participants who have a documented diagnosis of asthma and at least one severe exacerbation in the past year. This is a randomized, double-blind, multicenter Phase IIIb trial. Participants are randomly assigned in equal numbers to receive either BDA MDI 160180 micrograms 2 puffs of 8090 micrograms or AS MDI 180 micrograms 2 puffs of 90 micrograms as needed, alongside their usual maintenance asthma therapy. The study includes a 7 to 28-day screening period, a 52-week treatment period, and a safety follow-up lasting 7 to 14 days after treatment ends. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered at a separate visit after safety follow-up. During the study, participants will be monitored through regular assessments including lung function tests such as peak expiratory flow, evaluation of asthma exacerbations, and safety checks for adverse events. The main outcome measured is the annualized rate of severe asthma exacerbations over the 52-week treatment. Safety follow-up and pharmacokinetic evaluations will further assess drug concentrations and participant well-being. Overall participation lasts from screening through safety monitoring after treatment completion.

This trial investigates the efficacy and safety of benralizumab as an additional treatment for people aged 12 to 75 with uncontrolled eosinophilic asthma. These participants are already treated with a medium-dose inhaled corticosteroid and long-acting beta2-agonist ICS-LABA. The study compares adding benralizumab to increasing the inhaled therapy to a higher dose ICS-LABA. The research is a randomized, double-blind, active-controlled phase 3b trial designed to evaluate these treatments in people with a history of eosinophilic asthma who remain uncontrolled on medium-dose ICS-LABA with or without other controllers except oral corticosteroids. Participants are randomly assigned to one of two groups one receives benralizumab 30 mg by subcutaneous injection along with medium-dose ICS-LABA, and the other receives a placebo injection plus high-dose ICS-LABA. Doses of benralizumab or placebo are given every 4 weeks for the first three doses, then every 8 weeks, with up to seven injections during the study. The study treatment schedules continue for 48 weeks. During the study, participants will undergo assessments including lung function tests, asthma control questionnaires, and quality of life surveys. Researchers will track the annual rate of asthma exacerbations, time to first exacerbation, and safety events throughout the 48-week period. Compliance with asthma controller medication is monitored via daily diaries. This comprehensive evaluation helps understand the impact of adding benralizumab compared to increasing inhaled therapy dose in uncontrolled eosinophilic asthma.