Ignite Creation Date:
2024-05-06 @ 12:24 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01562028
Status:
COMPLETED
Last Update Posted:
2022-08-24
First Post:
2012-03-22
Brief Title:
BELIEF Bevacizumab and ErLotinib In EGFR Mut NSCLC
Sponsor:
ETOP IBCSG Partners Foundation
Organization:
ETOP IBCSG Partners Foundation
Study Overview
Official Title:
An Open-label Phase II Trial of Erlotinib and Bevacizumab in Patients With Advanced Non-small Cell Lung Cancer and Activating EGFR Mutations
Status:
COMPLETED
Status Verified Date:
2022-08
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:
BELIEF
Brief Summary:
Rationale
Advanced non-small-cell lung cancer NSCLC patients harbouring epidermal growth factor receptor EGFR mutations del19 or L858R show an impressive progression-free survival between 9 and 14 months when treated with erlotinib However the presence of EGFR mutations can only imperfectly predict outcome The investigators hypothesize that progression-free survival could be influenced both by the pretreatment EGFR T790M mutation and by components of DNA repair pathways
The investigators propose a model of treatment whereby patients with EGFR mutations single or with T790M can attain a benefit with longer overall PFS when treated with erlotinib plus bevacizumab When the patients are grouped by BRCA1 mRNA levels and T790M the hypothesis is that the combination of erlotinib plus bevacizumab can improve the PFS in all subgroups
Advanced non-small-cell lung cancer NSCLC patients harbouring epidermal growth factor receptor EGFR mutations del19 or L858R show an impressive progression-free survival between 9 and 14 months when treated with erlotinib However the presence of EGFR mutations can only imperfectly predict outcome The investigators hypothesize that progression-free survival could be influenced both by the pretreatment EGFR T790M mutation and by components of DNA repair pathways
The investigators propose a model of treatment whereby patients with EGFR mutations single or with T790M can attain a benefit with longer overall PFS when treated with erlotinib plus bevacizumab When the patients are grouped by BRCA1 mRNA levels and T790M the hypothesis is that the combination of erlotinib plus bevacizumab can improve the PFS in all subgroups
Detailed Description:
Objectives
1 To determine long-term outcome of patients with advanced non-squamous NSCLC harbouring EGFR mutations with or without T790M mutation at diagnosis and treated with the combination of erlotinib and bevacizumab Primary endpoint progression-free survival
2 To evaluate the efficacy and tolerability of the combination
3 To evaluate the correlation of BRCA1 mRNA and AEG-1 mRNA expression and T790M with progression-free survival
4 To monitor EGFR mutations including T790M in serum and plasma longitudinally
5 To evaluate molecular biomarkers related to EGFR TKI and bevacizumab
Design
This is a multinational multi-center phase II trial of erlotinib plus bevacizumab in patients with advanced non-squamous NSCLC harbouring EGFR mutations confirmed by central re-assessment Patients will be stratified into two subgroups with and without EGFR T790M mutation The stratification will be done after the inclusion of patients
Sample size 102 patients
1 To determine long-term outcome of patients with advanced non-squamous NSCLC harbouring EGFR mutations with or without T790M mutation at diagnosis and treated with the combination of erlotinib and bevacizumab Primary endpoint progression-free survival
2 To evaluate the efficacy and tolerability of the combination
3 To evaluate the correlation of BRCA1 mRNA and AEG-1 mRNA expression and T790M with progression-free survival
4 To monitor EGFR mutations including T790M in serum and plasma longitudinally
5 To evaluate molecular biomarkers related to EGFR TKI and bevacizumab
Design
This is a multinational multi-center phase II trial of erlotinib plus bevacizumab in patients with advanced non-squamous NSCLC harbouring EGFR mutations confirmed by central re-assessment Patients will be stratified into two subgroups with and without EGFR T790M mutation The stratification will be done after the inclusion of patients
Sample size 102 patients
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 |
|---|---|---|---|
| MO27911 | OTHER | Roche | None |
| 2011-004481-15 | EUDRACT_NUMBER | None | None |