Ignite Creation Date:
2024-05-06 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03623750
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2018-07-20
Brief Title:
E GFR TKI and EGF-P TI C Ombination in EGFR mutA nt NSCL C
Sponsor:
Instituto Oncológico Dr Rosell
Organization:
Instituto Oncológico Dr Rosell
Study Overview
Official Title:
A Multicentre Open-Label Exploratory Phase Ib Clinical Study to Assess Safety and Efficacy of an EGFR Tyrosine Kinase Inhibitor in Combination With EGF Pathway Targeting Immunisation EGF-PTI in Treatment-Naïve Patients With EGFR Mutant NSCLC The EPICAL Study
Status:
COMPLETED
Status Verified Date:
2022-06
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:
EPICAL
Brief Summary:
This is a multicentre open-label uncontrolled Phase Ib clinical study Patients who give informed consent will be screened for the study including genotyping of the tumour and baseline characteristics Eligible patients will receive a single pre-treatment of low dose of intravenous cyclophosphamide 200 mgm2 Day -3 Patients will commence daily oral therapy with the EGFR TKI afatinib as soon as possible preferably on the same day as low dose cyclophosphamide Afatinib will be prescribed according to the Summary of Product Characteristics SmPC of the product and will continue in nominal 21-day cycles for as long as clinically indicated The first day of dosing with EGF-PTI will be designated Day 1
Immunisation with EGF-PTI will commence 3 days after low dose cyclophosphamide and commencement of EGFR TKI and will be repeated on Day 14 Day 28 Day 43 and Day 92 After the 5 th vaccination patients will be followed up every 6 weeks for basic safety data and every 3 months for complete efficacy data safety data and maintenance reduced doses of EGF-PTI Patients will continue in the study until disease progression death safety concerns in the opinion of the investigator non-compliance with the protocol the patient withdraws from the study 1 year after randomisation of the last patient or the study is stopped the sponsor whichever occurs sooner
Immunisation with EGF-PTI will commence 3 days after low dose cyclophosphamide and commencement of EGFR TKI and will be repeated on Day 14 Day 28 Day 43 and Day 92 After the 5 th vaccination patients will be followed up every 6 weeks for basic safety data and every 3 months for complete efficacy data safety data and maintenance reduced doses of EGF-PTI Patients will continue in the study until disease progression death safety concerns in the opinion of the investigator non-compliance with the protocol the patient withdraws from the study 1 year after randomisation of the last patient or the study is stopped the sponsor whichever occurs sooner
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 |
|---|---|---|---|
| 2017-003237-28 | EUDRACT_NUMBER | None | None |