Lung Cancer Clinical Trial
A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)
Summary
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 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
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There are 176 Locations for this study
Mobile Alabama, 36688, United States
Glendale Arizona, 85304, United States
Glendale Arizona, 85306, United States
Jonesboro Arkansas, 72401, United States
Burbank California, 91505, United States
Encinitas California, 92008, United States
La Jolla California, 92037, United States
Sacramento California, 95816, United States
San Luis Obispo California, 93401, United States
Whittier California, 90603, United States
New Britain Connecticut, 06050, United States
Norwich Connecticut, 06360, United States
Boca Raton Florida, 33428, United States
Jacksonville Florida, 32207, United States
Jacksonville Florida, 32256, United States
Miami Beach Florida, 33140, United States
Rockledge Florida, 32955, United States
Atlanta Georgia, 30322, United States
Savannah Georgia, 31405, United States
Post Falls Idaho, 83854, United States
Elk Grove Village Illinois, 60007, United States
Evanston Illinois, 60201, United States
Joliet Illinois, 60435, United States
Niles Illinois, 60714, United States
River Forest Illinois, 60305, United States
Indianapolis Indiana, 46237, United States
Newburgh Indiana, 47630, United States
Ames Iowa, 50010, United States
Wichita Kansas, 67214, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40245, United States
Baton Rouge Louisiana, 70809, United States
Lafayette Louisiana, 70508, United States
Scarborough Maine, 04074, United States
York Maine, 03909, United States
Annapolis Maryland, 21401, United States
Boston Massachusetts, 02111, United States
Ann Arbor Michigan, 48106, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49546, United States
Saint Louis Park Minnesota, 55416, United States
Saint Joseph Missouri, 64507, United States
Saint Louis Missouri, 63131, United States
Stony Brook New York, 11794, United States
Hickory North Carolina, 28602, United States
Canton Ohio, 44710, United States
Columbus Ohio, 43219, United States
Dayton Ohio, 45420, United States
Middletown Ohio, 45042, United States
Toledo Ohio, 43617, United States
Coos Bay Oregon, 97420, United States
Bethlehem Pennsylvania, 18015, United States
Dunmore Pennsylvania, 18512, United States
Langhorne Pennsylvania, 19047, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19140, United States
Wynnewood Pennsylvania, 19096, United States
Pawtucket Rhode Island, 02860, United States
Germantown Tennessee, 38138, United States
Knoxville Tennessee, 37920, United States
Dallas Texas, 75390, United States
Portsmouth Virginia, 23704, United States
Roanoke Virginia, 24014, United States
Spokane Washington, 99208, United States
Appleton Wisconsin, 54915, United States
La Crosse Wisconsin, 54601, United States
Madison Wisconsin, 53792, United States
Buenos Aires , C1426, Argentina
La Pampa , 6300, Argentina
Mar Del Plata , 7600, Argentina
Rosario , S2000, Argentina
Santa Fe , 03000, Argentina
Viedma, Rio Negro , 8500, Argentina
Hohenems , 6845, Austria
Innsbruck , 6020, Austria
Natters , 6161, Austria
Steyr , 4400, Austria
Wels , 4600, Austria
Wien , 1090, Austria
Wien , 1130, Austria
Wien , 1140, Austria
Bruxelles , 1180, Belgium
Salvador, Bahia BA, 40170, Brazil
Fortaleza CE, 60125, Brazil
Brasilia DF, 70200, Brazil
Brasilia DF, 70390, Brazil
Taguatinga DF, 72110, Brazil
Rio de Janeiro RJ, 22793, Brazil
Ijui RS, 98700, Brazil
Itajai SC, 88301, Brazil
Sao Paulo SP, 01509, Brazil
São Paulo SP, CEP 0, Brazil
Hillerod , 3400, Denmark
Aix En Provence , 13617, France
Caen , 14076, France
Creteil , 94010, France
Gleize , 69400, France
Lille , 59020, France
Lille , 59037, France
Lyon , 69394, France
Marseille , 13285, France
Marseille , 13915, France
Nice , 06189, France
Pierre Benite , 69310, France
Pontoise , 95300, France
Saint Herblain , 44805, France
St-Priest-En-Jarez , 42271, France
Strasbourg , 67065, France
Toulon , 83041, France
Toulon , 83056, France
Toulouse , 31076, France
Vesoul , 70014, France
Bad Berka , 99437, Germany
Bergisch Gladbach , 51465, Germany
Esslingen , 73730, Germany
Frankfurt , 60488, Germany
Gera , 07548, Germany
Großhansdorf , 22927, Germany
Halle (Saale) , 06120, Germany
Homburg/Saar , 66421, Germany
Immenhausen , 34376, Germany
Karlsruhe , 76137, Germany
Leipzig , 04207, Germany
Leipzig , 04357, Germany
Minden , 32429, Germany
Muenchen , 80336, Germany
Oldenburg , 26121, Germany
Athens , 11527, Greece
Piraeus , 185 4, Greece
Thessaloniki , 570 1, Greece
Thessaloniki , 57001, Greece
Avellino Campania, 83100, Italy
Napoli Campania, 80131, Italy
Roma Lazio, 00128, Italy
Roma Lazio, 00152, Italy
Genova Liguria, 16132, Italy
Saronno Lombardia, 21047, Italy
Pisa Toscana, 56124, Italy
Aichi , 464-8, Japan
Chiba , 277-8, Japan
Ehime , 791-0, Japan
Fukuoka , 811-1, Japan
Hyogo , 673-8, Japan
Kanagawa , 236-0, Japan
Kanagawa , 240-8, Japan
Miyagi , 981-1, Japan
Okayama , 700-8, Japan
Osaka , 534-0, Japan
Osaka , 541-8, Japan
Shizuoka , 411-8, Japan
Tokyo , 104-0, Japan
Tokyo , 135-8, Japan
Beirut , 11-23, Lebanon
Beirut , 16830, Lebanon
Beirut , , Lebanon
Aguascalientes , 20230, Mexico
Mexico City , 14140, Mexico
Mexico City , , Mexico
Breda , 4818 , Netherlands
Den Haag , 2504 , Netherlands
Eindhoven , 5623 , Netherlands
Harderwijk , 3844 , Netherlands
Maastricht , 6202 , Netherlands
Nieuwegein , 3435 , Netherlands
Muscat , P.O B, Oman
Banska Bystrica , 975 1, Slovakia
Bratislava , 826 0, Slovakia
Kosice , 04001, Slovakia
Nitra , 949 8, Slovakia
Barakaldo Vizcaya, 48903, Spain
Alicante , 3010, Spain
Madrid , 28033, Spain
Madrid , 28040, Spain
Madrid , 28046, Spain
Valencia , 46010, Spain
Valencia , 46017, Spain
Zaragoza , 50009, Spain
Al Ain , 15258, United Arab Emirates
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