An Open-label Phase II Trial of Erlotinib and Bevacizumab in Patients With Advanced Non-small Cell Lung Cancer and Activating EGFR Mutations
18 Years
N/A
Both
Lung Cancer
Trial Information
An Open-label Phase II Trial of Erlotinib and Bevacizumab in Patients With Advanced Non-small Cell Lung Cancer and Activating EGFR Mutations
Objectives:
1. 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
2. To evaluate the efficacy and tolerability of the combination
3. To evaluate the correlation of BRCA1 mRNA and AEG-1 mRNA expression and T790M with
progression-free survival
4. To monitor EGFR mutations (including T790M) in serum longitudinally
5. To evaluate molecular biomarkers related to EGFR TKI and bevacizumab
Design:
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival
Outcome Description:
Time from the date of enrolment until documented progression or death, whichever occurs first.
Outcome Time Frame:
Within 6 months of the last visit of last patient, approximately 54 months after inclusion of first patient
Safety Issue:
No
Principal Investigator
Rafael Rosell, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Catalan Institute of Oncology, Hospital Germans Trias i Pujol
Authority:
Switzerland: Swissmedic
Study ID:
ETOP 2-11 / MO27911
NCT ID:
NCT01562028
Start Date:
June 2012
Completion Date:
October 2016
Related Keywords:
- Lung Cancer
- non small cell lung cancer
- advanced
- non-squamous
- EGFR
- mutations
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|
