A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer
1 other identifier
interventional
2,252
36 countries
308
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2006
Typical duration for phase_4
308 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 22, 2007
CompletedFirst Posted
Study publicly available on registry
March 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
April 25, 2016
CompletedMay 24, 2016
April 1, 2016
2.8 years
March 22, 2007
March 23, 2016
April 25, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Adverse Events of Special Interest
Participants with adverse events (AEs) of special interest (hypertension, proteinuria, wound healing complications, gastrointestinal perforation, arterial and venous thromboembolic events, hemoptysis, Central Nervous System (CNS) bleeding, other hemorrhage events and congestive heart failure) were reported.
Up to 3 years
Number of Participants With Serious Adverse Events Related to Bevacizumab
Participants with serious adverse events (SAEs) related to bevacizumab were reported for the duration of the study.
Up to 3 years
Secondary Outcomes (3)
Duration of Overall Survival
Up to 3 years
Time to Disease Progression
Up to 3 years
Number of Participants With Central Nervous System Bleeding
Up to 3 years
Study Arms (1)
Bevacizumab + Chemotherapy
EXPERIMENTALParticipants with advanced or recurrent NSCLC will be administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab will be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (369)
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Buenos Aires, 1272, Argentina
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Chaco-resistencia, 3400, Argentina
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Córdoba, 5000, Argentina
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Córdoba, 5016, Argentina
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San Miguel de Tucumán, T400IAK, Argentina
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St Leonards, New South Wales, 2065, Australia
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Waratah, New South Wales, 2298, Australia
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Auchenflower, Queensland, 4066, Australia
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Chermside, Queensland, 4032, Australia
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Tugun, Queensland, 4224, Australia
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Box Hill, Victoria, 3128, Australia
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Geelong, Victoria, 3220, Australia
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Malvern, Victoria, 3144, Australia
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Wodonga, Victoria, 3690, Australia
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Perth, Western Australia, 6008, Australia
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Sydney, New South Wales, 2077, Australia
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Bludesch, 6712, Austria
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Bregenz, 6900, Austria
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Feldkirch, 6807, Austria
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Knittelfeld, 8720, Austria
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Kufstein, 6330, Austria
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Linz, 4010, Austria
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Linz, 4020, Austria
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Natters, 6161, Austria
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Salzburg, 5020, Austria
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Sankt Veit an der Glan, 9300, Austria
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Vienna, 1030, Austria
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Vienna, 1090, Austria
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Vienna, 1130, Austria
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Vienna, 1140, Austria
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Vienna, 1145, Austria
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Vöcklabruck, 4840, Austria
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Wels, 4600, Austria
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Zams, 6511, Austria
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Banja Luka, 78000, Bosnia and Herzegovina
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Sarajevo, 71000, Bosnia and Herzegovina
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Fortaleza, Ceará, 60430-230, Brazil
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Vitória, Espírito Santo, 29055-270, Brazil
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Salvador, Bahia, Estado de Bahia, 40170-110, Brazil
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Goiânia, Goiás, 74075-040, Brazil
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Belo Horizonte, Minas Gerais, 30110-090, Brazil
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Belo Horizonte, Minas Gerais, 30150-320, Brazil
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Recife, Pernambuco, 52012-220, Brazil
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Rio de Janeiro, Rio de Janeiro, 20520-100, Brazil
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Rio de Janeiro, Rio de Janeiro, 22260-020, Brazil
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Rio de Janeiro, Rio de Janeiro, 22631-004, Brazil
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Ijuí, Rio Grande do Sul, 98700-000, Brazil
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Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
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Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
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Porto Alegre, Rio Grande do Sul, 90430-090, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Campinas, São Paulo, 13059-900, Brazil
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Campinas, São Paulo, 13073-400, Brazil
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Jaú, São Paulo, 17210-120, Brazil
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Ribeirão Preto, São Paulo, 14025-270, Brazil
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Santos, São Paulo, 11075-350, Brazil
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São Paulo, São Paulo, 01246-000, Brazil
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São Paulo, São Paulo, 01308-505, Brazil
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São Paulo, São Paulo, 01323-020, Brazil
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São Paulo, São Paulo, 01323-903, Brazil
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São Paulo, São Paulo, 01509-900, Brazil
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São Paulo, São Paulo, 05401-400, Brazil
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São Paulo, São Paulo, 08270-070, Brazil
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Vancouver, British Columbia, V5Z 4E6, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Beijing, 100021, China
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Beijing, 100730, China
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Beijing, 101149, China
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Guangzhou, 510060, China
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Guangzhou, 510080, China
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Hangzhou, 310022, China
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Shanghai, 200032, China
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Shanghai, 200433, China
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Bogotá, Colombia
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Cali, Colombia
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Manizales, Colombia
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Brno, 626 91, Czechia
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Pilsen, 305 99, Czechia
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Prague, 150 06, Czechia
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Aarhus, 8000, Denmark
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Herlev, 2730, Denmark
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Hillerød, 3400, Denmark
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Næstved, 4700, Denmark
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Guayaquil, 3623, Ecuador
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Quito, 17114965, Ecuador
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Cairo, 11737, Egypt
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Cairo, 11796, Egypt
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Tallinn, 11619, Estonia
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Tartu, 51003, Estonia
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Helsinki, 00290, Finland
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Paimio, 21540, Finland
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Pori, 28500, Finland
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Tampere, 33520, Finland
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Aix-en-Provence, 13616, France
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Avignon, 84000, France
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Besançon, 75015, France
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Béziers, 34525, France
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Bordeaux, 33076, France
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Brest, 29200, France
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Caen, 14076, France
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Chalon-sur-Saône, 71100, France
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Clermont-Ferrand, 63003, France
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Gap, 5000, France
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Grenoble, 38100, France
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Le Chesnay, 33300, France
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Lille, 59020, France
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Lille, 59037, France
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Lille, 59042, France
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Lyon, 69004, France
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Marseille, 13008, France
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Marseille, 13273, France
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Marseille, 13274, France
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Meaux, 77104, France
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Nancy, 54100, France
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Neuilly-sur-Seine, 92200, France
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Paris, 75248, France
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Paris, 75571, France
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Perpignan, 66000, France
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Reims, 51100, France
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Saint-Julien-en-Genevois, 74160, France
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Strasbourg, 67085, France
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Strasbourg, 69091, France
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Toulon, 83000, France
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Toulon, 83056, France
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Toulouse, 31052, France
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Toulouse, 31400, France
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Valenciennes, 59300, France
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Vandœuvre-lès-Nancy, 54511, France
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Augsburg, 86150, Germany
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Bad Berka, 99437, Germany
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Bayreuth, 95455, Germany
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Berlin, 12167, Germany
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Berlin, 12200, Germany
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Berlin, 13353, Germany
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Bielefeld, 33604, Germany
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Bonn, 53113, Germany
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Cologne, 50677, Germany
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Coswig, 01640, Germany
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Donaustauf, 93093, Germany
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Düsseldorf, 40225, Germany
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Ebensfeld, 96250, Germany
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Erlangen, 91054, Germany
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Essen, 45147, Germany
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Frankfurt, 60488, Germany
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Freiburg im Breisgau, 79106, Germany
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Gauting, 82131, Germany
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Gerlingen, 70839, Germany
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Göttingen, 37075, Germany
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Großhansdorf, 22927, Germany
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Halle, 06120, Germany
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Hamburg, 21075, Germany
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Hamburg, 22081, Germany
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Hanover, 30169, Germany
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Hanover, 30625, Germany
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Karlsruhe, 76137, Germany
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Kiel, 24116, Germany
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Leer, 26789, Germany
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Leipzig, 04207, Germany
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Leverkusen, 51375, Germany
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Löwenstein, 74245, Germany
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Magdeburg, 39120, Germany
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Mainz, 55131, Germany
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Minden, 32423, Germany
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München, 80336, Germany
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Neuruppin, 16816, Germany
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Nuremberg, 90419, Germany
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Oldenburg, 26121, Germany
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Rostock, 18057, Germany
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Treuenbrietzen, 14929, Germany
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Ulm, 89081, Germany
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Villingen-Schwenningen, 78045, Germany
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Wiesbaden, 65199, Germany
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Wolfsburg, 38440, Germany
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Würselen, 52146, Germany
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Hong Kong, 852, Hong Kong
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Hong Kong, Hong Kong
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Shatin, Hong Kong
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Budapest, 1529, Hungary
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Mátraháza, 3233, Hungary
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Pécs, 7635, Hungary
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Szombathely, 9700, Hungary
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Törökbálint, 2045, Hungary
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Reykjavik, 101, Iceland
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Beersheba, 84101, Israel
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Haifa, 31096, Israel
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Jerusalem, 12000, Israel
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Jerusalem, 91031, Israel
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Kfar Saba, 44281, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 64239, Israel
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Ẕerifin, 70300, Israel
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Avezzano, Abruzzo, 67051, Italy
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Pescara, Abruzzo, 65100, Italy
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Bari, Apulia, 70126, Italy
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Brindisi, Apulia, 72100, Italy
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San Giovanni Rotondo, Apulia, 71013, Italy
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Potenza, Basilicate, 85100, Italy
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Rionero in Vulture, Basilicate, 85029, Italy
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Catanzaro, Calabria, 88100, Italy
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Avellino, Campania, 83100, Italy
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Napoli, Campania, 80131, Italy
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Bologna, Emilia-Romagna, 40138, Italy
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Carpi, Emilia-Romagna, 41012, Italy
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Modena, Emilia-Romagna, 41100, Italy
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Rimini, Emilia-Romagna, 47900, Italy
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Aviano, Friuli Venezia Giulia, 33081, Italy
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Udine, Friuli Venezia Giulia, 33100, Italy
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Rome, Lazio, 00100, Italy
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Rome, Lazio, 00144, Italy
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Rome, Lazio, 00161, Italy
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Sora, Lazio, 03039, Italy
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Viterbo, Lazio, 01100, Italy
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Genoa, Liguria, 16132, Italy
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Genoa, Liguria, 16149, Italy
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La Spezia, Liguria, 19100, Italy
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Bergamo, Lombardy, 24128, Italy
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Cremona, Lombardy, 26100, Italy
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Milan, Lombardy, 20132, Italy
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Milan, Lombardy, 20162, Italy
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Pavia, Lombardy, 27100, Italy
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S Fermo Della Battaglia, Lombardy, 22100, Italy
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Sondrio, Lombardy, 23100, Italy
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Novara, Piedmont, 28100, Italy
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Cagliari, Sardinia, 09121, Italy
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Sassari, Sardinia, 07100, Italy
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Catania, Sicily, 95100, Italy
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Catania, Sicily, 95122, Italy
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Palermo, Sicily, 90127, Italy
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Taormina, Sicily, 98039, Italy
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Ancona, The Marches, Italy
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Arezzo, Tuscany, 52100, Italy
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Lido di Camaiore, Tuscany, 55043, Italy
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Pisa, Tuscany, 56100, Italy
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Camposampiero, Veneto, 35012, Italy
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Feltre - Bl, Veneto, 32032, Italy
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Negrar, Veneto, 37024, Italy
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Bologna, Umbria, 6132, Italy
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Forli, Emilia-Romagna, 47100, Italy
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Riga, LV 1079, Latvia
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Riga, LV-1002, Latvia
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Beirut, 99999, Lebanon
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Kaunas, 50009, Lithuania
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Klaipėda, 5808, Lithuania
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Vilnius, 08660, Lithuania
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Chihuahua City, 31000, Mexico
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León, 37150, Mexico
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Mexico City, 14080, Mexico
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Mexico City, 16200, Mexico
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Arnhem, 6815 AD, Netherlands
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Breda, 4818 CK, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Groningen, 9728 NZ, Netherlands
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Haarlem, 2035 RC, Netherlands
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Helmond, 5700 AB, Netherlands
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Hoofddorp, 2134 TM, Netherlands
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Nieuwegein, 3430 CM, Netherlands
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Schiedam, 3116 BA, Netherlands
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The Hague, 2504 LN, Netherlands
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Tiel, 4002 WP, Netherlands
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Zwolle, 8011 JW, Netherlands
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Bialystok, 15-540, Poland
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Krakow, 31-115, Poland
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Lublin, 20-950, Poland
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Poznan, 60-569, Poland
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Warsaw, 02-781, Poland
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Warsaw, 04-394, Poland
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Zabrze, 41-483, Poland
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Braga, 4719, Portugal
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Coimbra, 55643, Portugal
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Lisbon, 1070, Portugal
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Lisbon, 1600, Portugal
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Lisbon, 17769-001, Portugal
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Porto, 4200-072, Portugal
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Porto, 4200, Portugal
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Santa Maria da Feira, 4520-211, Portugal
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Setúbal, 2910-446, Portugal
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Vila Nova de Gaia, 4400-129, Portugal
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Bucharest, 010816, Romania
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Cluj-Napoca, 3400, Romania
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Timișoara, 300223, Romania
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Balashikha, 143900, Russia
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Engel's, 413115, Russia
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Irkutsk, 664035, Russia
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Kislino, Kursk Region, 305035, Russia
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Krasnodar, 350086, Russia
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Moscow, 107005, Russia
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Moscow, 115478, Russia
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Moscow, 143423, Russia
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Samara, 443066, Russia
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Smolensk, 214000, Russia
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Stavropol, 355047, Russia
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Tver', 170008, Russia
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Tyumen, 625047, Russia
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Ulyanovsk, ND, Russia
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Belgrade, 11000, Serbia
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Bratislava, 825 56, Slovakia
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Košice, 041 90, Slovakia
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Nitra, 949 88, Slovakia
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Poprad, 058 87, Slovakia
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Golnik, 4204, Slovenia
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Ljubljana, 1000, Slovenia
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Alicante, Alicante, 3010, Spain
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Elche, Alicante, 03202, Spain
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Palma de Mallorca, Balearic Islands, 07014, Spain
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Barcelona, Barcelona, 08025, Spain
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Barcelona, Barcelona, 08907, Spain
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Barcelona, Barcelona, 08916, Spain
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Manresa, Barcelona, 08243, Spain
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Mataró, Barcelona, 08304, Spain
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Sabadell, Barcelona, 08208, Spain
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Terrassa, Barcelona, 08221, Spain
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Santander, Cantabria, 39008, Spain
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Girona, Girona, 17007, Spain
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Huesca, Huesca, 22004, Spain
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A Coruña, La Coruña, 15006, Spain
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Lugo, Lugo, 27004, Spain
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Alcorcón, Madrid, 28922, Spain
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Madrid, Madrid, 28002, Spain
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Madrid, Madrid, 28034, Spain
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Madrid, Madrid, 28035, Spain
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Madrid, Madrid, 28040, Spain
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Madrid, Madrid, 28041, Spain
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Madrid, Madrid, 28046, Spain
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Murcia, Murcia, 30008, Spain
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Pamplona, Navarre, 31008, Spain
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Salamanca, Salamanca, 37007, Spain
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San Cristóbal de La Laguna, Tenerife, 38320, Spain
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Valencia, Valencia, 41014, Spain
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Valencia, Valencia, 46009, Spain
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Valencia, Valencia, 46010, Spain
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Valencia, Valencia, 46015, Spain
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Barakaldo, Vizcaya, 48903, Spain
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Zaragoza, Zaragoza, 50009, Spain
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Gothenburg, 41345, Sweden
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Lund, 22185, Sweden
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Malmo, 20502, Sweden
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Örebro, 70185, Sweden
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Stokholm, Solna, 01716, Sweden
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Umeå, 90185, Sweden
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Uppsala, 751 85, Sweden
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Aarau, 5000, Switzerland
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Baden, 5404, Switzerland
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Genolier, 1272, Switzerland
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Locarno, 6601, Switzerland
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Taichung, 407, Taiwan
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Tainan, 704, Taiwan
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Taipei, 100, Taiwan
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Taipei, 112, Taiwan
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Taoyuan District, 333, Taiwan
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Ankara, 06530, Turkey (Türkiye)
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Gaziantep, 27310, Turkey (Türkiye)
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Istanbul, 34300, Turkey (Türkiye)
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Istanbul, 34383, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Sıhhiye, Ankara, 06100, Turkey (Türkiye)
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Aberdeen, AB25 2ZN, United Kingdom
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Belfast, BT9 7AB, United Kingdom
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Birmingham, B9 5SS, United Kingdom
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Cambridge, PE3 6DA, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Manchester, M23 9LT, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Suffolk, IP33 2QZ, United Kingdom
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Barcelona, 6001, Venezuela
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Barquisimeto, 3001, Venezuela
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Porlamar, 6301, Venezuela
Related Publications (2)
Bearz A, Passalacqua R, Alabiso O, Cinieri S, Gridelli C, Cravesana C, Crino L. First-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer : analysis of the Italian patients enrolled in the SAiL study. Clin Drug Investig. 2012 Nov;32(11):755-60. doi: 10.1007/s40261-012-0001-9.
PMID: 23018280DERIVEDCrino L, Dansin E, Garrido P, Griesinger F, Laskin J, Pavlakis N, Stroiakovski D, Thatcher N, Tsai CM, Wu YL, Zhou C. Safety and efficacy of first-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer (SAiL, MO19390): a phase 4 study. Lancet Oncol. 2010 Aug;11(8):733-40. doi: 10.1016/S1470-2045(10)70151-0. Epub 2010 Jul 23.
PMID: 20650686DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2007
First Posted
March 26, 2007
Study Start
August 1, 2006
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
May 24, 2016
Results First Posted
April 25, 2016
Record last verified: 2016-04