drugset / Trial / NCT04874844

JY025 is a First-line Treatment for EGFR Mutated NSCLC Phase II and III Clinical Trials of Efficacy and Safety

NCT04874844 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The Phase II study is a multi-center, open, dose escalation and dose extension clinical trial. It is planned to enroll 24 patients; the phase III study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. It is planned to enroll 396 patients, including patients with locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR mutations (EGFR 19 exon deletion or 21 exon mutation).

Timeline

Start
2021-07-30
Primary completion
2022-03-30
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject JY025 Monoclonal antibody 10 mg/kg —
Subject JY025 Monoclonal antibody 12 mg/kg —
Subject JY025 Monoclonal antibody 16 mg/kg —