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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 18Years - 130YearsAll GendersPhase 3
303 locations
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Actively Recruiting

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.

Age: 5Years - 11YearsAll GendersPhase 3
143 locations
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Actively Recruiting

Researchers are evaluating iptacopan LNP023 alongside standard care to study its effectiveness, safety, and tolerability in adults with active lupus nephritis Class III-IV, with or without Class V. This phase 2 trial is randomized, double-blind, and placebo-controlled, aiming to explore dosing and treatment outcomes in this patient group. Participants receive either iptacopan combined with standard care, placebo matching iptacopan with standard care, or iptacopan with placebo as part of the standard care. Each treatment is taken for 52 weeks. The study proceeds in two parts, with different combination regimens of iptacopan, placebo, and standard care, including oral corticosteroids or their absence. During the study, participants undergo assessments at baseline and weeks 24 and 52 to measure kidney response, protein levels in urine, fatigue, and lupus disease activity using specific scoring tools. Researchers monitor the proportion of patients achieving complete renal response without flares and other kidney and health outcomes. Safety and tolerability are also evaluated over the course of treatment and follow-up.

Age: 18Years - 100YearsAll GendersPhase 2
103 locations