Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04878016
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2021-04-29
Brief Title:
A Study of Carboplatin Plus Etoposide With or Without ZKAB001 Anti-PD-L1 Antibody in Patients With ES-SCLC
Sponsor:
Lees Pharmaceutical Limited
Organization:
Lees Pharmaceutical Limited
Study Overview
Official Title:
A Phase III RandomizedDouble-blind Placebo-controlled Study of Carboplatin Plus Etoposide With or Without ZKAB001 Anti-PD-L1 Antibody in Patients With Untreated Extensive-stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
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:
This is a randomized Phase III multicenter double-blinded placebo-controlled study designed to evaluate the safety and efficacy of ZKAB001 in combination with carboplatin etoposide compared with treatment with placebo carboplatin etoposide in patients who have ES-SCLC and are untreated for their extensive-stage disease
Detailed Description:
This study is a randomized double-blind placebo-controlled multicenter III study
Eligible patients will randomly enter the trial group or control group at 11 that is ZKAB001 carboplatin etoposide or placebo carboplatin etoposide with a treatment cycle every 3 weeks There are 4 cycles of chemotherapy
Stratification factors included gender male female PS score 01 and brain metastasis yes no
The study included screening period treatment period subjects received study treatment until confirmed disease progression or intolerable toxic reaction or reached the maximum medication cycle of 2 years or the subject voluntarily requested the end of the study treatment and follow-up period including safety follow-up and survival follow-up
Eligible patients will randomly enter the trial group or control group at 11 that is ZKAB001 carboplatin etoposide or placebo carboplatin etoposide with a treatment cycle every 3 weeks There are 4 cycles of chemotherapy
Stratification factors included gender male female PS score 01 and brain metastasis yes no
The study included screening period treatment period subjects received study treatment until confirmed disease progression or intolerable toxic reaction or reached the maximum medication cycle of 2 years or the subject voluntarily requested the end of the study treatment and follow-up period including safety follow-up and survival follow-up
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