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

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

Brief 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.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase II single ;Phase III parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Phase II open label non-randomizedand ;Phase III randomized
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date: July 30, 2021
Estimated Primary Completion Date: March 30, 2022
Estimated Study Completion Date: June 30, 2023

Arm:
- Test drug group
- Active Comparator: Group type

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