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

Completed · Phase 3

Conditions studied: Non-Squamous Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01351415

Run by

Hoffmann-La Roche

People needed

485

Starts

2011-06-25

Expected to finish

2016-06-25

Last updated by the study team

2017-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Palo Verde Hema/Onc — Glendale, Arizona, United States
• Arizona Center for Cancer Care — Glendale, Arizona, United States
• Clopton Clinic — Jonesboro, Arkansas, United States
• East Valley Hematology ; Oncology Medical Group — Burbank, California, United States
• California Cancer Associates for Research & Excellence, Inc. — Encinitas, California, United States
• Scripps Clinic; Hematology & Oncology — La Jolla, California, United States
• Sutter Cancer Center — Sacramento, California, United States
• Coastal Integrative Cancer Care — San Luis Obispo, California, United States
• Innovative Clinical Research Institute — Whittier, California, United States
• The Hospital of Central CT — New Britain, Connecticut, United States
• Eastern Ct Hema/Onco Assoc; Dept of Oncology — Norwich, Connecticut, United States
• Lynn Cancer Institute - West — Boca Raton, Florida, United States
• Baptist - MD Anderson Cancer Center — Jacksonville, Florida, United States
• Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) — Jacksonville, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Cancer Care Centers of Brevard — Rockledge, Florida, United States
• Emory Univ Winship Cancer Inst — Atlanta, Georgia, United States
• Summit Cancer Care PC — Savannah, Georgia, United States
• Kootenai Cancer Center — Post Falls, Idaho, United States
• Alexian Brothers Neurosci Inst — Elk Grove Village, Illinois, United States
• Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr — Evanston, Illinois, United States
• Joliet Oncology Hematology Associates, Ltd. — Joliet, Illinois, United States
• Cancer Care & Hematology; Specialists of Chicagoland — Niles, Illinois, United States
• W. Suburban Ctr for Cncer Care — River Forest, Illinois, United States
• USA Mitchell Cancer Institute — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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