Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT01673867
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2012-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous 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:
True
If Expanded Access, NCT#:
NCT03126643
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
CheckMate057
Brief Summary:
The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy
Detailed Description:
CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-002472-14 | EUDRACT_NUMBER | None | View |