Onomichi

Researchers are evaluating novel combination treatment options for adults with locally advanced or metastatic Non-Small Cell Lung Cancer NSCLC in this Phase II, multi-center, open-label study. The trial includes several sub-studies focused on specific NSCLC populations based on genomic alterations and PD-L1 expression levels. The study aims to assess the safety, tolerability, and preliminary antitumor activity of various drug combinations across approximately 80 centers worldwide. Participants will receive one of three investigational drug combinations administered by intravenous infusion rilvegostomig with or without ramucirumab for first-line NSCLC with non-actionable genomic alterations and varying PD-L1 expression levels, or Dato-DXd combined with ramucirumab with or without rilvegostomig for later-line NSCLC with actionable genomic alterations. Treatments continue until disease progression, unacceptable side effects, or withdrawal from the study. Each sub-study may include initial safety run-in cohorts followed by dose expansion cohorts. Throughout the study, participants will undergo regular evaluations including tumor imaging to assess response, clinical safety monitoring, and laboratory testing. Researchers will measure outcomes such as adverse events, objective response rates, progression-free survival, and overall survival over an average of three years. Pharmacokinetics and immunogenicity of the study drugs will also be monitored. Participation involves ongoing treatment and follow-up visits until study completion or discontinuation.

Pancreatic cancer is often diagnosed at an advanced stage, and there is no established effective population-based screening method. This study evaluates the Enzeavour Pancreatic Cancer assay, a blood test that measures three specific enzymes at a single-molecule level and combines four biomarkers into a composite Enzeavour Score. The trial is a nationwide, multicenter, prospective, single-arm feasibility study conducted in Japan, enrolling about 10,000 asymptomatic adults. Participants undergo the Enzeavour assay during routine health checkups or organized cancer screening visits. Those with an Enzeavour Score above 0.369 are referred for further diagnostic imaging, which may include MRCP, EUS, or contrast-enhanced CT based on clinical indications. This study uses a partial verification design with 12-month follow-up for specific subgroups to estimate pancreatic cancer detection rates and positive predictive value. Throughout the study, participants provide peripheral blood samples for the assay and may undergo diagnostic imaging if their test is positive. Researchers monitor pancreatic cancer detection within 12 months after the blood draw as the primary outcome and measure the positive predictive value of the assay as a secondary outcome. The study duration extends up to the end of 2028, with safety and diagnostic results followed during this period.