Ignite Creation Date:
2024-05-06 @ 3:34 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02328105
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2014-12-17
Brief Title:
LCI-LUN-ABR-001 Carbo With Nab-Paclitaxel in Patients With Advanced NSCL Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
LCI-LUN-ABR-001 A Pilot Study of Carboplatin With Nab-Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer of Squamous Histology
Status:
COMPLETED
Status Verified Date:
2021-05
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:
ABRAXANE based on results from prior studies is a promising drug in squamous cell carcinoma of the lung This study will help to explore the combination of ABRAXANE and carboplatin more thoroughly in the subgroup of patients who had the best response in prior studies as well as determine whether there are any biomarkers which can predict for response
Detailed Description:
This is a single arm phase II study for subjects receiving first line therapy for metastatic squamous cell lung cancer Following informed consent and eligibility check all subjects will receive therapy with carboplatin and ABRAXANE on an outpatient basis A total of 50 subjects will be enrolled over an enrollment period of about 24 months Interim analyses will be conducted after the enrollment of subject 15 subject 30 and subject 45 Tissue biomarkers will be analyzed at baseline and blood biomarkers will be analyzed at baseline pre-dose on cycles 3 and 5 and then within 30 days of last dose of study treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 00010224 | None | None | None |