BELIEF (Bevacizumab and ErLotinib In EGFR Mut+ NSCLC)

Sponsor
ETOP IBCSG Partners Foundation
Study ID
NCT01562028
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Patients will be treated with erlotinib, 150 mg p.o., daily
  • Bevacizumab — DRUG
    Patients will be treated with bevacizumab 15 mg/kg i.v. on day 1 of each 3-week cycle (+/- 3 days)

Study Details

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.

Key Dates

First listed
Mar 23, 2012
Start date
Jun 30, 2012
Status verified
Aug 2022
Primary completion
Oct 31, 2018
Completion
Oct 31, 2018

Study Design

Enrollment
109 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Progression Free Survival [ Time Frame: From the date of enrollment until documented progression or death, whichever occurs first, assessed up to 48 months. ]

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