Back to resultsA Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Primary Purpose
Non-Squamous Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cisplatin
Gemcitabine
Placebo
bevacizumab [Avastin]
bevacizumab [Avastin]
Sponsored by
About this trial
This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival
Secondary Outcome Measures
Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response.
Safety:AEs, laboratory tests, SAEs, coagulation parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00806923
Brief Title
A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1044 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
iv on day 1 of each 3 week cycle until disease progression
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
15mg/kg 1v on day 1 of each 3 week cycle until disease progression
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Event driven
Secondary Outcome Measure Information:
Title
Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response.
Time Frame
Event driven
Title
Safety:AEs, laboratory tests, SAEs, coagulation parameters
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Bahia Blanca
ZIP/Postal Code
8000
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1270AAE
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
City
Santa Fe
ZIP/Postal Code
03000
Country
Argentina
City
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
City
Adelaide
ZIP/Postal Code
5011
Country
Australia
City
Adelaide
ZIP/Postal Code
5065
Country
Australia
City
Brisbane
ZIP/Postal Code
4029
Country
Australia
City
Canberra
ZIP/Postal Code
2606
Country
Australia
City
Kurralta Park
ZIP/Postal Code
5037
Country
Australia
City
Melbourne
ZIP/Postal Code
3128
Country
Australia
City
Parkville
ZIP/Postal Code
3052
Country
Australia
City
Perth
ZIP/Postal Code
6009
Country
Australia
City
Sydney
ZIP/Postal Code
2050
Country
Australia
City
Sydney
ZIP/Postal Code
2139
Country
Australia
City
Tugun
ZIP/Postal Code
4224
Country
Australia
City
Wollongong
ZIP/Postal Code
2500
Country
Australia
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
City
Haine-saint-paul
ZIP/Postal Code
7100
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Belo Horizonte
ZIP/Postal Code
30150321
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01221-020
Country
Brazil
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
City
Stara Zagora
ZIP/Postal Code
8000
Country
Bulgaria
City
Varna
ZIP/Postal Code
9002
Country
Bulgaria
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9N 1N8
Country
Canada
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
City
Sainte-foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
City
Ostrava
ZIP/Postal Code
703 84
Country
Czech Republic
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
City
Praha
ZIP/Postal Code
180 01
Country
Czech Republic
City
Usti Nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
City
Belfort
ZIP/Postal Code
90016
Country
France
City
Bobigny
ZIP/Postal Code
93009
Country
France
City
Caen
ZIP/Postal Code
14076
Country
France
City
Lyon
ZIP/Postal Code
69004
Country
France
City
Marseille
ZIP/Postal Code
13273
Country
France
City
Montbeliard
ZIP/Postal Code
25209
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
City
Rennes
ZIP/Postal Code
35033
Country
France
City
Rouen
ZIP/Postal Code
76000
Country
France
City
St Herblain
ZIP/Postal Code
44805
Country
France
City
Strasbourg
ZIP/Postal Code
67091
Country
France
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
City
Berlin
ZIP/Postal Code
14165
Country
Germany
City
Essen
ZIP/Postal Code
45122
Country
Germany
City
Gauting
ZIP/Postal Code
82131
Country
Germany
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
City
Hamburg
ZIP/Postal Code
22045
Country
Germany
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
City
Hemer
ZIP/Postal Code
58675
Country
Germany
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
City
Leverkusen
ZIP/Postal Code
51375
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
City
München
ZIP/Postal Code
80336
Country
Germany
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
City
Athens
ZIP/Postal Code
11522
Country
Greece
City
Athens
ZIP/Postal Code
11527
Country
Greece
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
City
Hong Kong
Country
Hong Kong
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
City
Mosdos
ZIP/Postal Code
7257
Country
Hungary
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
City
Szekesfehervar
ZIP/Postal Code
8001
Country
Hungary
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
City
Zalaegerszeg
ZIP/Postal Code
8901
Country
Hungary
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
City
Ramat-gan
ZIP/Postal Code
52621
Country
Israel
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
City
Catania
ZIP/Postal Code
95123
Country
Italy
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Milano
ZIP/Postal Code
20133
Country
Italy
City
Milano
ZIP/Postal Code
20162
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Parma
ZIP/Postal Code
43100
Country
Italy
City
Perugia
ZIP/Postal Code
06132
Country
Italy
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
City
Roma
ZIP/Postal Code
00152
Country
Italy
City
Roma
ZIP/Postal Code
00168
Country
Italy
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
City
Lublin
ZIP/Postal Code
20-950
Country
Poland
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
City
Szczecin
ZIP/Postal Code
70-891
Country
Poland
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
City
Balashikha
ZIP/Postal Code
143900
Country
Russian Federation
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
City
Moscow
ZIP/Postal Code
107005
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
City
Moscow
ZIP/Postal Code
123098
Country
Russian Federation
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
City
Alicante
ZIP/Postal Code
03010
Country
Spain
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Girona
ZIP/Postal Code
17007
Country
Spain
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Madrid
ZIP/Postal Code
28222
Country
Spain
City
Málaga
ZIP/Postal Code
29010
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
City
Valencia
ZIP/Postal Code
41014
Country
Spain
City
Valencia
ZIP/Postal Code
46009
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Valencia
ZIP/Postal Code
46015
Country
Spain
City
Kueishan
ZIP/Postal Code
333
Country
Taiwan
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
City
Taipei
ZIP/Postal Code
105
Country
Taiwan
City
Taipei
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M2O 4BX
Country
United Kingdom
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
City
Yeovil
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21245868
Citation
Leighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18.
Results Reference
derived
PubMed Identifier
20978447
Citation
Leighl NB, Zatloukal P, Mezger J, Ramlau R, Moore N, Reck M, Manegold C. Efficacy and safety of bevacizumab-based therapy in elderly patients with advanced or recurrent nonsquamous non-small cell lung cancer in the phase III BO17704 study (AVAiL). J Thorac Oncol. 2010 Dec;5(12):1970-6. doi: 10.1097/JTO.0b013e3181f49c22.
Results Reference
derived
PubMed Identifier
20150572
Citation
Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C; BO17704 Study Group. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol. 2010 Sep;21(9):1804-1809. doi: 10.1093/annonc/mdq020. Epub 2010 Feb 11.
Results Reference
derived
Learn more about this trial
A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
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