Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04501497
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2020-08-02
Brief Title:
Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer J-TAIL-2
Sponsor:
Chugai Pharmaceutical
Organization:
Chugai Pharmaceutical
Study Overview
Official Title:
Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Patients With Unresectable Advanced and Recurrent Non-small Cell Lung Cancer or Extensive Disease Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2024-04
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 multi-center observational study of atezolizumab combination therapy in patients with unresectable advanced and recurrent non-small cell lung cancerNSCLC or extensive disease small cell lung cancerED-SCLC 800 patients in NSCLC cohort and 400 patients in ED-SCLC cohort will be enrolled in this trial to assess the efficacy and safety of this combination
Detailed Description:
Primary endpoint 12 months OS Secondary endpoints Overall SurvivalOS 6 months survival rate6mo OS 12 months survival rate12mo OS Progression-Free SurvivalPFS Time to treatment failure TTF Objective Response RateORR Disease Control RateDCR Duration of ResponseDOR Safety and Comprehensive geriatric assessmentG8
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