A Study of Avastin (Bevacizumab) in Combination With Standard of Care Treatment in Patients With Lung Cancer



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/3/2016
Start Date:June 2011
End Date:June 2016

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An Open-label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) After First (1st)-Line Treatment With Bevacizumab Plus a Platinum Doublet-containing Chemotherapy

This open-label, randomized, multicenter study will evaluate the efficacy and safety of
Avastin (bevacizumab) in combination with standard of care treatment in patients with
advanced non-squamous non-small cell lung cancer (NSCLC). Patients will be enrolled at
documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with
Avastin plus a platinum doublet-containing therapy and a minimum of two cycles of Avastin
maintenance treatment prior to PD. Patients will be randomly assigned to one of two
treatment arms to receive either Avastin plus standard of care treatment or standard of care
treatment alone.


Inclusion Criteria:

- Adult patients, age >/=18 years

- Histologically or cytologically confirmed non-squamous non-small cell lung cancer
(NSCLC)

- Documented progression of disease (locally recurrent or metastatic) per investigator
assessment following first-line treatment 4-6 cycles of Avastin plus a platinum
doublet-containing chemotherapy regimen and a minimum of 2 cycles of Avastin
(monotherapy) maintenance treatment prior to first progression of disease

- No treatment interruption of Avastin treatment greater than 2 consecutive cycles (42
days) between the start of first-line treatment to start of Cycle 1 of second line
treatment

- Randomization within 4 weeks of progression of disease

- At least one unidimensionally measurable lesion meeting RECIST criteria

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

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

- History of hemoptysis >/=grade 2 within 3 months of randomization

- Major cardiac disease
We found this trial at
68
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