Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448572
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-03
Brief Title:
EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
EXLIBRIS
Brief Summary:
As treatment options are limited following progression on anti PD-L1 and platinum-based chemotherapy we propose this trial for patients who have failed to respond or have shown intolerance to standard therapies or for whom no appropriate therapies are known to provide clinical benefit Considering the strong therapeutic rationale of an association between antineoplastic immunotherapy and EXL01 single-strain of F prausnitzii a bacteria which is a dominant member of the healthy gut microbiota we propose to assess this combination for NSCLC treatment This is a pilot Phase III one-arm monocentric study evaluating the combination of EXL01 with nivolumab treatment for Non-Small Cell Lung Cancer patients
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 |
|---|---|---|---|
| 2023-505285-28-01 | CTIS | None | None |