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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00451906




Registration number
NCT00451906
Ethics application status
Date submitted
22/03/2007
Date registered
26/03/2007
Date last updated
24/05/2016

Titles & IDs
Public title
A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
Scientific title
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
Secondary ID [1] 0 0
MO19390
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 - Platinum-based chemotherapy
Treatment: Drugs - Bevacizumab [Avastin]

Experimental: Bevacizumab + Chemotherapy - Participants 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.


Treatment: Drugs: Platinum-based chemotherapy
As prescribed

Treatment: Drugs: Bevacizumab [Avastin]
15 mg/kg IV on Day 1 of each 3 week cycle

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 3 years
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Duration of Overall Survival - Overall survival time was defined as time between first bevacizumab administration and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive.
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Time to Disease Progression - Time to disease progression was defined as time between first bevacizumab administration and date of first occurrence of progressive disease. Participants who had not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Number of Participants With Central Nervous System Bleeding - The incidence of central nervous system (CNS) bleeding was reported for participants who developed CNS metastases during the study period and who did not have Computed Tomography (CT) or magnetic resonance imaging (MRI) techniques of the head performed at baseline.
Timepoint [3] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Single group
Other design features
Phase
Phase 4
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
- St. Leonards
Recruitment hospital [2] 0 0
- Waratah
Recruitment hospital [3] 0 0
- Auchenflower
Recruitment hospital [4] 0 0
- Chermside
Recruitment hospital [5] 0 0
- Tugun
Recruitment hospital [6] 0 0
- Box Hill
Recruitment hospital [7] 0 0
- Geelong
Recruitment hospital [8] 0 0
- Malvern
Recruitment hospital [9] 0 0
- Wodonga
Recruitment hospital [10] 0 0
- Perth
Recruitment hospital [11] 0 0
- Sydney, New South Wales
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
4224 - Tugun
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
3144 - Malvern
Recruitment postcode(s) [9] 0 0
3690 - Wodonga
Recruitment postcode(s) [10] 0 0
6008 - Perth
Recruitment postcode(s) [11] 0 0
2077 - Sydney, New South Wales
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
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Argentina
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Chaco-resistencia
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Cordoba
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Córdoba
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Tucuman
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Bludesch
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Austria
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Bregenz
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Austria
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Feldkirch
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Knittelfeld
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Austria
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Kufstein
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Austria
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Linz
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State/province [14] 0 0
Natters
Country [15] 0 0
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State/province [15] 0 0
Salzburg
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Austria
State/province [16] 0 0
St Veit An Der Glan
Country [17] 0 0
Austria
State/province [17] 0 0
Vöcklabruck
Country [18] 0 0
Austria
State/province [18] 0 0
Wels
Country [19] 0 0
Austria
State/province [19] 0 0
Wien
Country [20] 0 0
Austria
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Zams
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Banja Luka
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BA
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CE
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ES
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Brazil
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GO
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Brazil
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MG
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Brazil
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PE
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Brazil
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RJ
Country [30] 0 0
Brazil
State/province [30] 0 0
RS
Country [31] 0 0
Brazil
State/province [31] 0 0
SP
Country [32] 0 0
Canada
State/province [32] 0 0
British Columbia
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
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State/province [34] 0 0
Beijing
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China
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China
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Hangzhou
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China
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Shanghai
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Cali
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Herlev
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Hillerod
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Århus
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Ecuador
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Quito
Country [50] 0 0
Egypt
State/province [50] 0 0
Cairo
Country [51] 0 0
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State/province [51] 0 0
Tallinn
Country [52] 0 0
Estonia
State/province [52] 0 0
Tartu
Country [53] 0 0
Finland
State/province [53] 0 0
Helsinki
Country [54] 0 0
Finland
State/province [54] 0 0
Paimio
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Finland
State/province [55] 0 0
Pori
Country [56] 0 0
Finland
State/province [56] 0 0
Tampere
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France
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Aix En Provence
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France
State/province [58] 0 0
Avignon
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Besancon
Country [60] 0 0
France
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Beziers
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Bordeaux
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Brest
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Caen
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France
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Chalon Sur Saone
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France
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Clermont-ferrand
Country [66] 0 0
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GAP
Country [67] 0 0
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Grenoble
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Le Chesnay
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Lille
Country [70] 0 0
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State/province [70] 0 0
Lyon
Country [71] 0 0
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State/province [71] 0 0
Marseille
Country [72] 0 0
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State/province [72] 0 0
Meaux
Country [73] 0 0
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State/province [73] 0 0
Nancy
Country [74] 0 0
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State/province [74] 0 0
Neuilly Sur Seine
Country [75] 0 0
France
State/province [75] 0 0
Paris
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State/province [76] 0 0
Perpignan
Country [77] 0 0
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State/province [77] 0 0
Reims
Country [78] 0 0
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State/province [78] 0 0
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Country [79] 0 0
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Coswig
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State/province [92] 0 0
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Frankfurt
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State/province [101] 0 0
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State/province [103] 0 0
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Germany
State/province [106] 0 0
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Germany
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Leer
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Germany
State/province [109] 0 0
Leipzig
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Germany
State/province [110] 0 0
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Country [111] 0 0
Germany
State/province [111] 0 0
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Germany
State/province [112] 0 0
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Germany
State/province [113] 0 0
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Country [114] 0 0
Germany
State/province [114] 0 0
Minden
Country [115] 0 0
Germany
State/province [115] 0 0
Muenchen
Country [116] 0 0
Germany
State/province [116] 0 0
Neuruppin
Country [117] 0 0
Germany
State/province [117] 0 0
Nürnberg
Country [118] 0 0
Germany
State/province [118] 0 0
Oldenburg
Country [119] 0 0
Germany
State/province [119] 0 0
Rostock
Country [120] 0 0
Germany
State/province [120] 0 0
Treuenbrietzen
Country [121] 0 0
Germany
State/province [121] 0 0
Ulm
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Germany
State/province [122] 0 0
Villingen-Schwenningen
Country [123] 0 0
Germany
State/province [123] 0 0
Wiesbaden
Country [124] 0 0
Germany
State/province [124] 0 0
Wolfsburg
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Germany
State/province [125] 0 0
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Hong Kong
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Hong Kong
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Shatin
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Hungary
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Budapest
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Hungary
State/province [129] 0 0
Mátraháza
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Hungary
State/province [130] 0 0
Pecs
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Hungary
State/province [131] 0 0
Szombathely
Country [132] 0 0
Hungary
State/province [132] 0 0
Torokbalint
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Iceland
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Reykjavik
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Israel
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Haifa
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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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Ramat Gan
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Israel
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Tel Aviv
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Israel
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Italy
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Basilicata
Country [143] 0 0
Italy
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Italy
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Campania
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Italy
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Italy
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Marche
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Italy
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Piemonte
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Italy
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State/province [154] 0 0
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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Mexico
State/province [164] 0 0
Chihuahua
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Mexico
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Leon
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Mexico
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Mexico City
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Netherlands
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Arnhem
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Breda
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Haarlem
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Helmond
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Schiedam
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Netherlands
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Tiel
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Zwolle
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Poland
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Bialystok
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Krakow
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Lublin
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Warszawa
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Portugal
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Braga
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Coimbra
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Lisboa
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Porto
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State/province [189] 0 0
Santa Maria Da Feira
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State/province [190] 0 0
Setubal
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Portugal
State/province [191] 0 0
Vila Nova De Gaia
Country [192] 0 0
Romania
State/province [192] 0 0
Bucharest
Country [193] 0 0
Romania
State/province [193] 0 0
Cluj Napoca
Country [194] 0 0
Romania
State/province [194] 0 0
Timisoara
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Russian Federation
State/province [195] 0 0
Balashikha
Country [196] 0 0
Russian Federation
State/province [196] 0 0
Engels
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Russian Federation
State/province [197] 0 0
Irkutsk
Country [198] 0 0
Russian Federation
State/province [198] 0 0
Kislino, Kursk Region
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Russian Federation
State/province [199] 0 0
Krasnodar
Country [200] 0 0
Russian Federation
State/province [200] 0 0
Moscow
Country [201] 0 0
Russian Federation
State/province [201] 0 0
Samara
Country [202] 0 0
Russian Federation
State/province [202] 0 0
Smolensk
Country [203] 0 0
Russian Federation
State/province [203] 0 0
Stavropol
Country [204] 0 0
Russian Federation
State/province [204] 0 0
Tumen
Country [205] 0 0
Russian Federation
State/province [205] 0 0
Tver
Country [206] 0 0
Russian Federation
State/province [206] 0 0
Ulyanovsk
Country [207] 0 0
Serbia
State/province [207] 0 0
Belgrade
Country [208] 0 0
Slovakia
State/province [208] 0 0
Bratislava
Country [209] 0 0
Slovakia
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Kosice
Country [210] 0 0
Slovakia
State/province [210] 0 0
Nitra
Country [211] 0 0
Slovakia
State/province [211] 0 0
Poprad
Country [212] 0 0
Slovenia
State/province [212] 0 0
Golnik
Country [213] 0 0
Slovenia
State/province [213] 0 0
Ljubljana
Country [214] 0 0
Spain
State/province [214] 0 0
Alicante
Country [215] 0 0
Spain
State/province [215] 0 0
Barcelona
Country [216] 0 0
Spain
State/province [216] 0 0
Cantabria
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Porlamar

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

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00451906
Trial related presentations / publications
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
Other publications