BELIEF (Bevacizumab and ErLotinib In EGFR Mut+ NSCLC)

• Status: Completed
• Trial end date: 2018-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Thoracic Oncology Platform
• Collaborator: Spanish Lung Cancer Group
• Treatments: Bevacizumab; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• ECOG performance status 0-2

• Adequate haematological function, coagulation, liver function and renal function

• Pathological diagnosis of predominantly non-squamous, non-small-cell lung cancer (NSCLC)

• TNM version 7 stage IV disease including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease not amenable to curative treatment (including patients progressing after radiochemotherapy for stage III disease)

• Measurable or evaluable disease (according to RECIST 1.1 criteria).

• Centrally confirmed EGFR exon 19 deletion (del19) or exon 21 mutation (L858R)

Exclusion Criteria:

• Patients with increased risk of bleeding

• Patients with clinically significant cardiovascular diseases

• Patients with a history of thrombosis or thromboembolism in the 6 months prior to treatment

• Patients with gastrointestinal problems

• Patients with neurologic problems

• Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma.

• Patients with any known significant ophthalmologic anomaly of the ocular surface

• Patients who received prior chemotherapy for metastatic disease

• Patients who received previous treatment for lung cancer with drugs targeting EGFR or VEGF

• Pregnancy