At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓ECOG performance status 0-2
- ✓Pathologically confirmed predominantly non-squamous NSCLC
- ✓Stage IV disease (M1a or M1b) or locally advanced disease not amenable to curative treatment
- ✕History of thrombosis or thromboembolism within 6 months prior to treatment
- ✕Clinically significant cardiovascular disease
- ✕Increased risk of bleeding
- ✕Gastrointestinal problems
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Phase II Trial of Erlotinib and Bevacizumab in Patients With Advanced Non-small Cell Lung Cancer and Activating EGFR Mutations
In Brief
A Phase 2 clinical trial evaluating Erlotinib and Bevacizumab for Lung Cancer. Completed, enrolled 109 participants across 48 sites in 8 countries.
Detailed 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.
Study Details
Timeline
Interventions
Patients will be treated with erlotinib, 150 mg p.o., daily
Patients will be treated with bevacizumab 15 mg/kg i.v. on day 1 of each 3-week cycle (+/- 3 days)