Zenica

Researchers are evaluating the pharmacokinetics, safety, and tolerability of aumolertinib in European participants diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific mutations in the epidermal growth factor receptor (EGFR). This Phase 1, open-label, multicenter study focuses on patients with confirmed activating EGFR mutations, including ex19del, L858R, or T790M. The study targets those whose cancer is not suitable for curative surgery or definitive radiotherapy and who meet specific treatment history and health status requirements. Participants receive oral aumolertinib at a dose of 110 mg once daily during 21-day treatment cycles. In Part A, pharmacokinetic (PK) assessments are conducted on specified days within the first two cycles to measure drug and metabolite levels at various time points. In Part B, participants may continue the treatment beyond Cycle 2 until disease progression, intolerable toxicity, or other discontinuation criteria. Safety assessments and tumor evaluations take place according to clinical indications throughout the study. During the study, participants visit the site multiple times for PK sampling and safety checks, including laboratory tests and imaging scans to evaluate tumor response. The end of treatment visit occurs within 7 days after stopping the study drug, followed by a safety follow-up visit approximately 28 days later. The main outcomes measured are pharmacokinetic parameters such as Tmax, Cmax, AUC0-24h, and Cmin of aumolertinib and its metabolites on specific days of treatment cycles.

Researchers are evaluating the pharmacokinetics, efficacy, safety, and immune response of MB12, a proposed pembrolizumab biosimilar, compared to Keytruda® in patients with advanced stage IV non-squamous non-small cell lung cancer (NSCLC). This Phase 3, randomized, double-blind study involves patients who have not received prior systemic treatment for metastatic NSCLC and includes a range of international centers. The trial focuses on patients without EGFR activating mutations or ALK translocations and measures outcomes up to 24 weeks. Participants receive either MB12, EU-sourced Keytruda®, or US-sourced Keytruda®, each given as a 200 mg intravenous infusion every 3 weeks on Day 1. These immunotherapy drugs are combined with chemotherapy agents pemetrexed (500 mg/m2 IV every 3 weeks on Day 1) and either carboplatin (area under the curve 5 IV every 3 weeks on Day 1 for 4 cycles) or cisplatin (75 mg/m2 IV every 3 weeks on Day 1 for 4 cycles). The combination treatment is administered as a first-line therapy for metastatic NSCLC. During the study, patients are monitored for drug levels in the blood, treatment effectiveness, safety, and immune response. Regular assessments include imaging to measure tumor lesions using RECIST 1.1 criteria and evaluations of overall health and organ functions. The study aims to confirm that MB12 is similar to Keytruda® in how it is processed by the body and in its treatment results. Participants are followed for at least 24 weeks to collect data on these outcomes.