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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00806923




Registration number
NCT00806923
Ethics application status
Date submitted
10/12/2008
Date registered
11/12/2008
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Scientific 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
Secondary ID [1] 0 0
BO17704
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Squamous Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cisplatin
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Placebo
Treatment: Drugs - bevacizumab [Avastin]
Treatment: Drugs - bevacizumab [Avastin]

Experimental: 1 -

Experimental: 2 -

Placebo comparator: 3 -


Treatment: Drugs: Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles

Treatment: Drugs: Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles

Treatment: Drugs: Placebo
iv on day 1 of each 3 week cycle until disease progression

Treatment: Drugs: bevacizumab [Avastin]
15mg/kg 1v on day 1 of each 3 week cycle until disease progression

Treatment: Drugs: bevacizumab [Avastin]
7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
Event driven
Secondary outcome [1] 0 0
Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response.
Timepoint [1] 0 0
Event driven
Secondary outcome [2] 0 0
Safety:AEs, laboratory tests, SAEs, coagulation parameters
Timepoint [2] 0 0
Throughout study

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
1044
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Canberra
Recruitment hospital [4] 0 0
- Kurralta Park
Recruitment hospital [5] 0 0
- Melbourne
Recruitment hospital [6] 0 0
- Parkville
Recruitment hospital [7] 0 0
- Perth
Recruitment hospital [8] 0 0
- Sydney
Recruitment hospital [9] 0 0
- Tugun
Recruitment hospital [10] 0 0
- Wollongong
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
5065 - Adelaide
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
2606 - Canberra
Recruitment postcode(s) [5] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [6] 0 0
3128 - Melbourne
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment postcode(s) [8] 0 0
6009 - Perth
Recruitment postcode(s) [9] 0 0
2050 - Sydney
Recruitment postcode(s) [10] 0 0
2139 - Sydney
Recruitment postcode(s) [11] 0 0
4224 - Tugun
Recruitment postcode(s) [12] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
Argentina
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Bahia Blanca
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Argentina
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Buenos Aires
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Argentina
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Mendoza
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Argentina
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San Miguel de Tucuman
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Argentina
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Santa Fe
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Belgium
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Bruxelles
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Belgium
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Haine-saint-paul
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Belgium
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Leuven
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Belgium
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Liege
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Brazil
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Belo Horizonte
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Bulgaria
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Varna
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Bulgaria
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Veliko Tarnovo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Czech Republic
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Ostrava
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Czech Republic
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Praha
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Czech Republic
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Usti Nad Labem
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France
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Belfort
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France
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Bobigny
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France
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Caen
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France
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Lyon
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Marseille
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France
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Montbeliard
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France
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Montpellier
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France
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Pierre Benite
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France
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Rennes
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France
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Rouen
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France
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St Herblain
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France
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Strasbourg
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France
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Vandoeuvre Les Nancy
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Germany
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Berlin
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Germany
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Essen
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Germany
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Gauting
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Germany
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Göttingen
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Hemer
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Germany
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Karlsruhe
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Germany
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Leverkusen
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Germany
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Mainz
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Germany
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Mannheim
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München
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Greece
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Alexandroupolis
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Greece
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Athens
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Greece
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Thessaloniki
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
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Mosdos
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Hungary
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Nyiregyhaza
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Hungary
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Szekesfehervar
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Hungary
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Szombathely
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Zalaegerszeg
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Ramat-gan
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Israel
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Tel Aviv
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Italy
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Candiolo
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Italy
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Catania
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Italy
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Genova
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Italy
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Milano
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Napoli
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Parma
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Italy
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Perugia
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Italy
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Reggio Emilia
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Italy
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Roma
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Italy
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Rozzano
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Poland
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Gdansk
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Gdynia
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Lublin
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Olsztyn
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Poznan
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Poland
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Szczecin
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Poland
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Warszawa
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Russian Federation
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Balashikha
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Russian Federation
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Moscow
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Russian Federation
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St Petersburg
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Spain
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Alicante
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Spain
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Barakaldo
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Barcelona
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Girona
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La Laguna
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Sevilla
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Spain
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Valencia
Country [96] 0 0
Taiwan
State/province [96] 0 0
Kueishan
Country [97] 0 0
Taiwan
State/province [97] 0 0
Taichung
Country [98] 0 0
Taiwan
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Taipei
Country [99] 0 0
Thailand
State/province [99] 0 0
Bangkok
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Thailand
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Chiang Mai
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Guildford
Country [102] 0 0
United Kingdom
State/province [102] 0 0
London
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United Kingdom
State/province [103] 0 0
Manchester
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United Kingdom
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Sheffield
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Sutton
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Yeovil

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00806923
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00806923