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BELIEF (Bevacizumab and ErLotinib In EGFR Mut+ NSCLC)

NCT01562028 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2022-08-24

Study results available
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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.

Conditions

Interventions

DRUG

Erlotinib

Patients will be treated with erlotinib, 150 mg p.o., daily

DRUG

Bevacizumab

Patients will be treated with bevacizumab 15 mg/kg i.v. on day 1 of each 3-week cycle (+/- 3 days)

Sponsors & Collaborators

  • Spanish Lung Cancer Group

    collaborator OTHER

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Rafael Rosell, MD · Catalan Institute of Oncology, Hospital Germans Trias i Pujol

  • Stahel Rolf, MD · Laboratory of Molecular Oncology, Clinic of Oncology, University Hospital Zuerich

  • Miquel Taron · Medical Oncology Service-ICO, Hospital Germans Trias i Pujol

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01562028 on ClinicalTrials.gov