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A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

NCT01351415

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Interventions: Bevacizumab, Docetaxel, Erlotinib, Pemetrexed

Countries: United States, Argentina, Austria, Belgium, Brazil, Denmark, France, Germany

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Histologically or cytologically confirmed non-squamous NSCLC
* Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment with 4-6 cycles of Bevacizumab plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Bevacizumab (monotherapy) maintenance treatment prior to first progression of disease
* No treatment interruption of Bevacizumab 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 v1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Participants with adequate hematological, liver, and renal function
* Female participants must not be pregnant or breast-feeding. Female participants of childbearing potential and fertile male participants must agree to use a highly effective contraceptive during the trial and for a period of at least 6 months following the last administration of trial drug(s)

Exclusion Criteria:

* Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
* Epidermal growth factor receptor (EGFR)-mutation-positive disease according to local laboratory testing
* History of hemoptysis greater than or equal to (\>/=) grade 2 within 3 months of randomization
* History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding and active gastrointestinal bleeding
* Major cardiac disease
* Treatment with any other investigational agent within 28 days prior to randomization
* Known hypersensitivity to bevacizumab or any of its excipients, or any SOC drugs foreseen
* Malignancy other than NSCLC within 5 years prior to randomization and evidence of any other disease that contraindicates the use of an investigational or SOC drug

Locations (179)

Mobile, Alabama, United States
Glendale, Arizona, United States
Glendale, Arizona, United States
Jonesboro, Arkansas, United States
Burbank, California, United States
Encinitas, California, United States
La Jolla, California, United States
Sacramento, California, United States
San Luis Obispo, California, United States
Whittier, California, United States
New Britain, Connecticut, United States
Norwich, Connecticut, United States
Boca Raton, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Miami Beach, Florida, United States
Rockledge, Florida, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Post Falls, Idaho, United States
Elk Grove Village, Illinois, United States
Evanston, Illinois, United States
Joliet, Illinois, United States
Niles, Illinois, United States
River Forest, Illinois, United States
Indianapolis, Indiana, United States
Newburgh, Indiana, United States
Ames, Iowa, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
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