Overview

A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.

Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
All
Summary
This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Bevacizumab
Criteria
Inclusion Criteria:

- adult patients, >=18 years of age;

- histologically or cytologically documented inoperable, locally advanced ( stage III),
metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed
histology should be categorized by the predominant cell type);

- ECOG PS status 0-2;

- life expectancy >= 12weeks;

- adequate renal, liver and hematological function.

Exclusion Criteria:

- mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a
predominant squamous component;

- hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;

- evidence of tumor invading major blood vessels on imaging;

- evidence of CNS metastases, even if previously treated.

- major surgery (including open biopsy), significant traumatic injury within 28 days
prior to enrolment, or anticipation of need for major surgery during study treatment;

- prior chemotherapy for stage IIIb/IV disease.