NCT04874844

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

Recombinant Anti-VEGFR2 Fully Human Monoclonal Antibody (JY025) Injection Combined With Gefitinib/Erlotinib as First-line Treatment Phase II and III Clinical Trials on the Efficacy and Safety of Patients With EGFR-mutant NSCLC

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Beijing Dongfang Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The Phase II study is a multi-center, open, dose escalation and dose extension clinical trial. It is planned to enroll 24 patients with locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR mutation (EGFR 19 exon deletion or 21 exon mutation). Dose escalation select JY025 12mg/kg and 16mg/kg Q3W administration combined with EGFRTKI (gefitinib 250mg or erlotinib 150mg) QD plan, each dose group enrolled 6 subjects, in the first cycle Perform DLT evaluation. If 2/6 cases or more of DLT occur at 12 mg/kg, then the extended phase dose is reduced to 10 mg/kg; if 16 mg/kg occurs at 2/6 cases or more of DLT, the extended phase test is not performed at this dose. Dose expansion selects 1 or 2 doses of JY025 Q3W administration combined with EGFR-TKI (gefitinib 250mg or erlotinib 150mg) QD regimen, each dose group enrolled 6 subjects (gefitinib and Erlotinib (3 cases each). The Phase III study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. It is planned to enroll 396 patients with EGFR mutation (EGFR 19 exon deletion or 21 exon \[L858R\] mutation) with locally advanced or metastatic non-squamous non-small cell lung cancer. The study included a test drug group and a placebo control group. The dosage regimen of the test drug group was: JY025 is based on phase II clinical recommended dose, once every 21 days, gefitinib 250mg or erlotinib 150mg once a day; placebo The dosage regimen of the control group is: placebo is based on phase II clinical recommended dose, once every 21 days, gefitinib 250mg or erlotinib 150mg once a day. The ratio of the test drug group to the placebo control group is 1:1, and they will receive continuous administration until confirmed disease progression, intolerable toxicity, or meet any of the criteria for stopping the study medication.

Conditions

• NSCLC

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant anti-VEGFR2 fully human monoclonal antibody (JY025)	The ratio of subjects in the experimental drug group to the placebo control group is 1:1, and you will have a 50% probability of receiving JY025 combined with gefitinib or erlotinib, and a 50% probability of receiving placebo combined with gefitinib Or erlotinib. Blind people, researchers, nurses, research assistants, inspectors, applicants and blind statisticians involved in clinical trials.

Timeline

• Start date: 2021-07-30
• Primary completion: 2022-03-30
• Completion: 2023-06-30
• First posted: 2021-05-06
• Last updated: 2021-05-10