Ignite Creation Date:
2024-05-06 @ 12:48 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03856411
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2019-01-24
Brief Title:
A Study to Evaluate the Efficacy and Safety of Toripalimab or Placebo Combined With Chemotherapy in Treatment-naive Advanced NSCLC
Sponsor:
Shanghai Junshi Bioscience Co Ltd
Organization:
Shanghai Junshi Bioscience Co Ltd
Study Overview
Official Title:
A Phase III Randomized Double-blind Placebo-controlled Multi-center Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection JS001 or Placebo Combined With First-line Standard Chemotherapy in Treatment-naive Advanced Non-small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2023-01
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 one randomized double-blind placebo-controlled multi-center phase III clinical study to evaluate the efficacy and safety of Toripalimab injection JS001 or placebo combined with standard 1st-line chemotherapy in treatment-naïve advanced non-small cell lung cancer NSCLC and evaluate the population with the best predictive biomarkers ie positive diagnosis population
About 450 subjects with advanced non-small cell lung cancer without activated EGFR mutation exon 19 deletion or exon 21 L858R exon 21 L861Q exon 18 G719X or exon 20 S768I mutations and ALK fusion will be 21 randomized into two groups JS001 combined with the standard 1st-line chemotherapy will be given in the study group whereas placebo combined with standard 1st-line chemotherapy will be given in the control group The stratification will be based on the following factors
PD-L1 expression TC1 vs TC1 Smoking state often smoking vs no smoking or infrequent smoking Pathological type squamous cell carcinoma vs non-squamous cell carcinoma
About 450 subjects with advanced non-small cell lung cancer without activated EGFR mutation exon 19 deletion or exon 21 L858R exon 21 L861Q exon 18 G719X or exon 20 S768I mutations and ALK fusion will be 21 randomized into two groups JS001 combined with the standard 1st-line chemotherapy will be given in the study group whereas placebo combined with standard 1st-line chemotherapy will be given in the control group The stratification will be based on the following factors
PD-L1 expression TC1 vs TC1 Smoking state often smoking vs no smoking or infrequent smoking Pathological type squamous cell carcinoma vs non-squamous cell carcinoma
Detailed Description:
None
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