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Actively Recruiting

Researchers are evaluating whether accelerated BEP chemotherapy is more effective than the standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumors. This phase 3 trial focuses on patients with these tumor types, aiming to improve cure rates beyond those achieved with current treatments. The trial is led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group and addresses the need for better first-line treatments due to limited success and higher toxicity of previous strategies. The study compares two treatment regimens: standard BEP chemotherapy given every 3 weeks for 4 cycles and accelerated BEP chemotherapy given every 2 weeks for 4 cycles. Both regimens include Bleomycin, Etoposide, and Cisplatin administered intravenously at specified doses, plus supportive treatments with Pegylated G-CSF (Pegfilgrastim) and Filgrastim to help manage blood cell counts. The accelerated arm includes additional weekly doses of Bleomycin after the initial 4 cycles. These regimens are designed to test if faster cycling of chemotherapy drugs improves outcomes. Participants will be closely monitored from the time of randomization through up to 5 years for progression-free survival, which measures time until disease progression or death. Assessments include laboratory tests to check bone marrow, liver, and kidney function, as well as evaluations of overall health status. Participants must be able to start treatment within 14 days of randomization and comply with all study procedures. Safety and effectiveness of the treatments will be tracked throughout the study duration to determine if the accelerated regimen offers improved results.

Age: 11Years - 50YearsAll GendersPhase 3
28 locations
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Actively Recruiting

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) combined with Rilvegostomig or Rilvegostomig alone compared to Pembrolizumab alone as first-line treatments for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Participants must have high PD-L1 expression (tumor cells 50% or greater) and no actionable genetic changes. This Phase III, randomized, open-label global study focuses on this specific group of lung cancer patients without known targetable mutations. The trial includes three treatment groups: one receiving Dato-DXd plus Rilvegostomig intravenously, one receiving Rilvegostomig alone intravenously, and one receiving Pembrolizumab alone intravenously. Treatments are given as first-line therapy, meaning participants have not received prior systemic treatment for advanced disease. The study compares these treatments to assess their effect on cancer progression and survival. Participants will be closely monitored throughout the study, which includes assessments of progression-free survival over about four years and overall survival over about six years. Researchers will collect tumor samples to confirm PD-L1 and TROP2 status, perform scans to measure tumor response, and evaluate organ function and performance status. Safety and side effects will be tracked to understand treatment tolerability. The entire participation duration may extend up to several years to capture long-term outcomes.

Age: 18Years +All GendersPhase 3
281 locations
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