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Combination of Erlotinib (Tarceva®) and Bevacizumab (Avastin®) as Second-line Treatment in Locally Advanced / Metastatic, Non-squamous, Non-small Cell Lung Cancer (NSCLC) Patients: A Phase II Study

Phase 2
18 Years
Not Enrolling
Non-small-cell Lung Cancer

Thank you

Trial Information

Combination of Erlotinib (Tarceva®) and Bevacizumab (Avastin®) as Second-line Treatment in Locally Advanced / Metastatic, Non-squamous, Non-small Cell Lung Cancer (NSCLC) Patients: A Phase II Study

A randomized, placebo-controlled phase III trial of erlotinib versus placebo, demonstrated
that therapy with this tyrosine kinase inhibitor (TKI) prolongs survival after first or
second line therapy in patients with advanced NSCLC. Moreover, the addition of bevacizumab,
a monoclonal antibody against Vascular Endothelial Growth Factor bevacizumab (VEGF), to
systemic chemotherapy, improved both the response rates and the time to tumor progression in
two trials. Early data from phase I/II trials examining the combination of these two
biological agents in pre-treated patients with non-squamous NSCLC, showed no major
pharmacokinetic interactions and promising clinical activity.

Inclusion Criteria:

- Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB
with pleural effusion) and/or metastatic (stage IV) NSCLC

- Progression to first-line therapy for advanced/metastatic NSCLC

- Bi-dimensionally measurable disease (not included in radiation field)

- ECOG performance status of 0-2

- Life expectancy of more than 6 months

- Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5
times the upper normal limit in the absence of demonstrable liver metastases, or <5
times the upper normal limit in the presence of liver metastases,adequate renal
function (serum creatinine <1.5 times the upper normal limit),and bone marrow
(neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function

- Signed informed consent

Exclusion Criteria:

- Central nervous system involvement (unless if the patient has being previously
irradiated and is clinically stable)

- Presence of a centrally located mass or a tumor mass in close relation to large
vessels or a mass with cavitation.

- Surgery or radiation therapy within the last 14 days from study entry

- Active infection

- History of life-threatening hemoptysis / hematemesis, history of thrombosis or use of
anti-coagulation therapy

- History of significant cardiac disease (unstable angina, congestive heart failure,
myocardial infarction, ventricular arrhythmias) or stroke within the previous 6
months or uncontrolled hypertension

- Patients on other experimental treatment protocols

- History of a second primary malignancy (other than basal-cell skin carcinoma or in
situ carcinoma of the cervix)

- Psychiatric illness or social situation that would preclude study compliance

- Pregnant or lactating women

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

Objective responses confirmed by CT or MRI (on 3rd and

Safety Issue:


Principal Investigator

Sofia Agelaki, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete, Dep of Medical Oncology


Greece: National Organization of Medicines

Study ID:




Start Date:

July 2008

Completion Date:

September 2010

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • TKI's
  • Anti-VEGF
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms