BELIEF (Bevacizumab and ErLotinib In EGFR Mut+ NSCLC) (BELIEF)
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|ClinicalTrials.gov Identifier: NCT01562028|
Recruitment Status : Active, not recruiting
First Posted : March 23, 2012
Last Update Posted : January 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Erlotinib Drug: Bevacizumab||Phase 2|
- 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
- To evaluate the efficacy and tolerability of the combination
- To evaluate the correlation of BRCA1 mRNA and AEG-1 mRNA expression and T790M with progression-free survival
- To monitor EGFR mutations (including T790M) in serum and plasma longitudinally
- To evaluate molecular biomarkers related to EGFR TKI and bevacizumab
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: Erlotinib plus bevacizumab
Patients will be treated with erlotinib and bevacizumab. Bevacizumab: 15 mg/kg i.v. on day 1 of each 3-week cycle (+/- 3 days) Erlotinib: 150 mg p.o., daily
Patients will be treated with erlotinib, 150 mg p.o., daily
Other Name: Tarceva (R) (Roche)
Patients will be treated with bevacizumab 15 mg/kg i.v. on day 1 of each 3-week cycle (+/- 3 days)
Other Name: Avastin (R) Roche)
- Progression free survival [ Time Frame: Within 6 months of the last visit of last patient, approximately 54 months after inclusion of first patient ]Time from the date of enrolment until documented progression or death, whichever occurs first.
- Time to treatment failure [ Time Frame: Within 6 months of the last visit of last patient, approximately 54 months after inclusion of first patient ]Time from the date of enrolment to discontinuation of treatment for any reason (including progression of disease, treatment toxicity, refusal and death).
- Objective response [ Time Frame: termination of trial treatment ]Best overall response (complete remission or partial remission) across all assessment time-points according to RECIST Criteria 1.1, during the period from enrolment to termination of trial treatment.
- Toxicity [ Time Frame: Within 6 months of the last visit of last patient, approximately 54 months after inclusion of first patient ]Adverse events graded according to NCI CTCAE V4.
- Disease control [ Time Frame: Within 6 months of the last visit of last patient, approximately 54 months after inclusion of first patient ]Achievement of objective response or stable disease for at least 6 weeks.
- Duration of response [ Time Frame: Within 6 months of the last visit of last patient, approximately 54 months after inclusion of first patient ]Interval from the date of first documentation of objective response by RECIST to the date of first documented progression or relapse.
- Overall survival (OS) [ Time Frame: Within 6 months of the last visit of last patient, approximately 54 months after inclusion of first patient ]Time from the date of enrolment until death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562028
Show 48 Study Locations
|Study Chair:||Rafael Rosell, MD||Catalan Institute of Oncology, Hospital Germans Trias i Pujol|
|Study Chair:||Stahel Rolf, MD||Laboratory of Molecular Oncology, Clinic of Oncology, University Hospital Zuerich|
|Study Chair:||Miquel Taron||Medical Oncology Service-ICO, Hospital Germans Trias i Pujol|