A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00806923
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.

Condition or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: Cisplatin Drug: Gemcitabine Drug: Placebo Drug: bevacizumab [Avastin] Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1044 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC
Study Start Date : February 2005
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Drug: Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Drug: bevacizumab [Avastin]
15mg/kg 1v on day 1 of each 3 week cycle until disease progression
Experimental: 2 Drug: Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Drug: Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Drug: bevacizumab [Avastin]
7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression
Placebo Comparator: 3 Drug: Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Drug: Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Drug: Placebo
iv on day 1 of each 3 week cycle until disease progression

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Event driven ]

Secondary Outcome Measures :
  1. Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response. [ Time Frame: Event driven ]
  2. Safety:AEs, laboratory tests, SAEs, coagulation parameters [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;
  • adequate liver and kidney function;
  • women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment.

Exclusion Criteria:

  • prior chemotherapy or treatment with another systemic cancer therapy;
  • surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment;
  • brain metastasis or spinal cord compression;
  • fertile men, and women of childbearing potential, not using adequate contraception;
  • treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00806923

  Hide Study Locations
Bahia Blanca, Argentina, 8000
Buenos Aires, Argentina, C1270AAE
Buenos Aires, Argentina, C1426ANZ
Mendoza, Argentina, 5500
San Miguel de Tucuman, Argentina, 4000
Santa Fe, Argentina, 03000
Santa Fe, Argentina, 2000
Adelaide, Australia, 5011
Adelaide, Australia, 5065
Brisbane, Australia, 4029
Canberra, Australia, 2606
Kurralta Park, Australia, 5037
Melbourne, Australia, 3128
Parkville, Australia, 3052
Perth, Australia, 6009
Sydney, Australia, 2050
Sydney, Australia, 2139
Tugun, Australia, 4224
Wollongong, Australia, 2500
Bruxelles, Belgium, 1200
Haine-saint-paul, Belgium, 7100
Leuven, Belgium, 3000
Liege, Belgium, 4000
Belo Horizonte, Brazil, 30150321
Porto Alegre, Brazil, 90020-090
Rio de Janeiro, Brazil, 20231-050
Sao Paulo, Brazil, 01221-020
Plovdiv, Bulgaria, 4004
Sofia, Bulgaria, 1527
Sofia, Bulgaria, 1756
Stara Zagora, Bulgaria, 8000
Varna, Bulgaria, 9002
Veliko Tarnovo, Bulgaria, 5000
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Victoria, British Columbia, Canada, V8R 6V5
Canada, New Brunswick
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
London, Ontario, Canada, N6A 4L6
Mississauga, Ontario, Canada, L5M 2N1
Newmarket, Ontario, Canada, L3Y 2P9
Toronto, Ontario, Canada, M5G 1X5
Toronto, Ontario, Canada, M5G 2M9
Toronto, Ontario, Canada, M9N 1N8
Canada, Quebec
Greenfield Park, Quebec, Canada, J4V 2H1
Montreal, Quebec, Canada, H2L 4M1
Montréal, Quebec, Canada, H2W 1S6
Sainte-foy, Quebec, Canada, G1V 4G2
Czech Republic
Ostrava, Czech Republic, 703 84
Ostrava, Czech Republic, 708 52
Praha, Czech Republic, 180 01
Usti Nad Labem, Czech Republic, 401 13
Belfort, France, 90016
Bobigny, France, 93009
Caen, France, 14076
Lyon, France, 69004
Marseille, France, 13273
Montbeliard, France, 25209
Montpellier, France, 34295
Pierre Benite, France, 69495
Rennes, France, 35033
Rouen, France, 76000
St Herblain, France, 44805
Strasbourg, France, 67091
Vandoeuvre Les Nancy, France, 54511
Berlin, Germany, 14165
Essen, Germany, 45122
Gauting, Germany, 82131
Göttingen, Germany, 37075
Hamburg, Germany, 20246
Hamburg, Germany, 21075
Hamburg, Germany, 22045
Heidelberg, Germany, 69126
Hemer, Germany, 58675
Karlsruhe, Germany, 76137
Leverkusen, Germany, 51375
Mainz, Germany, 55131
Mannheim, Germany, 68167
München, Germany, 80336
Alexandroupolis, Greece, 68100
Athens, Greece, 11522
Athens, Greece, 11527
Thessaloniki, Greece, 57010
Hong Kong
Hong Kong, Hong Kong, 852
Hong Kong, Hong Kong
Budapest, Hungary, 1529
Mosdos, Hungary, 7257
Nyiregyhaza, Hungary, 4400
Szekesfehervar, Hungary, 8001
Szombathely, Hungary, 9700
Zalaegerszeg, Hungary, 8901
Jerusalem, Israel, 91120
Kfar Saba, Israel, 44281
Petach Tikva, Israel, 49100
Ramat-gan, Israel, 52621
Tel Aviv, Israel, 6423906
Candiolo, Italy, 10060
Catania, Italy, 95123
Genova, Italy, 16132
Milano, Italy, 20133
Milano, Italy, 20162
Napoli, Italy, 80131
Parma, Italy, 43100
Perugia, Italy, 06132
Reggio Emilia, Italy, 42100
Roma, Italy, 00152
Roma, Italy, 00168
Rozzano, Italy, 20089
Gdansk, Poland, 80-214
Gdynia, Poland, 81-519
Lublin, Poland, 20-950
Olsztyn, Poland, 10-228
Poznan, Poland, 60-569
Szczecin, Poland, 70-891
Warszawa, Poland, 02-781
Russian Federation
Balashikha, Russian Federation, 143900
Moscow, Russian Federation, 105229
Moscow, Russian Federation, 107005
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 123098
Moscow, Russian Federation, 143423
St Petersburg, Russian Federation, 197089
St Petersburg, Russian Federation, 197758
St Petersburg, Russian Federation, 198255
Alicante, Spain, 03010
Barakaldo, Spain, 48903
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Barcelona, Spain, 08907
Girona, Spain, 17007
La Laguna, Spain, 38320
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28046
Madrid, Spain, 28222
Málaga, Spain, 29010
Sevilla, Spain, 41013
Sevilla, Spain, 41014
Valencia, Spain, 41014
Valencia, Spain, 46009
Valencia, Spain, 46010
Valencia, Spain, 46015
Kueishan, Taiwan, 333
Taichung, Taiwan, 404
Taichung, Taiwan, 407
Taipei, Taiwan, 105
Taipei, Taiwan
Bangkok, Thailand, 10400
Chiang Mai, Thailand, 50200
United Kingdom
Guildford, United Kingdom, GU2 7XX
London, United Kingdom, N18 1QX
Manchester, United Kingdom, M2O 4BX
Sheffield, United Kingdom, S10 2SJ
Sutton, United Kingdom, SM2 5PT
Yeovil, United Kingdom, BA21 4AT
Sponsors and Collaborators
Hoffmann-La Roche
Study Chair: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00806923     History of Changes
Other Study ID Numbers: BO17704
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors