Ignite Creation Date:
2024-05-06 @ 2:37 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04379635
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2020-05-04
Brief Title:
Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer NSCLC
Sponsor:
BeiGene
Organization:
BeiGene
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase 3 Study to Compare the Efficacy and Safety of Neoadjuvant Treatment With Tislelizumab BGB-A317 Anti-PD-1 Antibody or Placebo Plus Platinum-Based Doublet Chemotherapy Followed By Adjuvant Tislelizumab or Placebo in Resectable Stage II or IIIA Non-Small Cell Lung Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
The primary objective of this study is to evaluate and compare major pathological responseMPR rate and event-free survival EFS in participants receiving tislelizumab plus platinum-based doublet chemotherapy as the new additional treatment followed by tislelizumab as adjuvant treatment versus participants receiving placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20200821 | REGISTRY | ChinaDrugTrials | None |