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An Open-label Phase II Trial of Erlotinib and Bevacizumab in Patients With Advanced Non-small Cell Lung Cancer and Activating EGFR Mutations

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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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


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


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

- 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

- 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

- Pregnancy

Type of Study:


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:


Principal Investigator

Rafael Rosell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Catalan Institute of Oncology, Hospital Germans Trias i Pujol


Switzerland: Swissmedic

Study ID:

ETOP 2-11 / MO27911



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