Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04874844
Status:
UNKNOWN
Last Update Posted:
2021-05-10
First Post:
2021-04-12
Brief Title:
JY025 is a First-line Treatment for EGFR Mutated NSCLC Phase II and III Clinical Trials of Efficacy and Safety
Sponsor:
Beijing Dongfang Biotech Co Ltd
Organization:
Beijing Dongfang Biotech Co Ltd
Study Overview
Official Title:
Recombinant Anti-VEGFR2 Fully Human Monoclonal Antibody JY025 Injection Combined With GefitinibErlotinib as First-line Treatment Phase II and III Clinical Trials on the Efficacy and Safety of Patients With EGFR-mutant NSCLC
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12mgkg and 16mgkg 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 26 cases or more of DLT occur at 12 mgkg then the extended phase dose is reduced to 10 mgkg if 16 mgkg occurs at 26 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 11 and they will receive continuous administration until confirmed disease progression intolerable toxicity or meet any of the criteria for stopping the study medication
Dose escalation select JY025 12mgkg and 16mgkg 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 26 cases or more of DLT occur at 12 mgkg then the extended phase dose is reduced to 10 mgkg if 16 mgkg occurs at 26 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 11 and they will receive continuous administration until confirmed disease progression intolerable toxicity or meet any of the criteria for stopping the study medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None