Clinical trial NCT00451906: A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-03-26
Enrollment: 2252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Number of Participants With Adverse Events of Special Interest
timeFrame: Up to 3 years
measure: Number of Participants With Serious Adverse Events Related to Bevacizumab
timeFrame: Up to 3 years
Secondary outcomes:
measure: Duration of Overall Survival
timeFrame: Up to 3 years
measure: Time to Disease Progression
timeFrame: Up to 3 years
measure: Number of Participants With Central Nervous System Bleeding
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Chaco-resistencia
country: Argentina
city: Cordoba
country: Argentina
city: Córdoba
country: Argentina
city: Tucuman
country: Argentina
city: St. Leonards
country: Australia
state: New South Wales
city: Waratah
country: Australia
state: New South Wales
city: Auchenflower
country: Australia
state: Queensland
city: Chermside
country: Australia
state: Queensland
city: Tugun
country: Australia
state: Queensland
city: Box Hill
country: Australia
state: Victoria
city: Geelong
country: Australia
state: Victoria
city: Malvern
country: Australia
state: Victoria
city: Wodonga
country: Australia
state: Victoria
city: Perth
country: Australia
state: Western Australia
city: Sydney, New South Wales
country: Australia
city: Bludesch
country: Austria
city: Bregenz
country: Austria
city: Feldkirch
country: Austria
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Knittelfeld
country: Austria
city: Kufstein
country: Austria
city: Linz
country: Austria
city: Linz
country: Austria
city: Natters
country: Austria
city: Salzburg
country: Austria
city: St Veit An Der Glan
country: Austria
city: Vöcklabruck
country: Austria
city: Wels
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Zams
country: Austria
city: Banja Luka
country: Bosnia and Herzegovina
city: Sarajevo
country: Bosnia and Herzegovina
city: Salvador, Bahia
country: Brazil
state: BA
city: Fortaleza
country: Brazil
state: CE
city: Vitoria
country: Brazil
state: ES
city: Goiania
country: Brazil
state: GO
city: Belo Horizonte
country: Brazil
state: MG
city: Belo Horizonte
country: Brazil
state: MG
city: Recife
country: Brazil
state: PE
city: Rio De Janeiro
country: Brazil
state: RJ
city: Rio de Janeiro
country: Brazil
state: RJ
city: Rio de Janeiro
country: Brazil
state: RJ
city: Ijui
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
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state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Campinas
country: Brazil
state: SP
city: Campinas
country: Brazil
state: SP
city: Jau
country: Brazil
state: SP
city: Ribeirao Preto
country: Brazil
state: SP
city: Santos
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Vancouver
country: Canada
state: British Columbia
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Guangzhou
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Bogota
country: Colombia
city: Cali
country: Colombia
city: Manizales
country: Colombia
city: Brno
country: Czech Republic
city: Plzen
country: Czech Republic
city: Praha
country: Czech Republic
city: Herlev
country: Denmark
city: Hillerod
country: Denmark
city: Naestved
country: Denmark
city: Århus
country: Denmark
city: Guayaquil
country: Ecuador
city: Quito
country: Ecuador
city: Cairo
country: Egypt
city: Cairo
country: Egypt
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Helsinki
country: Finland
city: Paimio
country: Finland
city: Pori
country: Finland
city: Tampere
country: Finland
city: Aix En Provence
country: France
city: Avignon
country: France
city: Besancon
country: France
city: Beziers
country: France
city: Bordeaux
country: France
city: Brest
country: France
city: Caen
country: France
city: Chalon Sur Saone
country: France
city: Clermont-ferrand
country: France
city: GAP
country: France
city: Grenoble
country: France
city: Le Chesnay
country: France
city: Lille
country: France
city: Lille
country: France
city: Lille
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Meaux
country: France
city: Nancy
country: France
city: Neuilly Sur Seine
country: France
city: Paris
country: France
city: Paris
country: France
city: Perpignan
country: France
city: Reims
country: France
city: St Julien En Genevois
country: France
city: Strasbourg
country: France
city: Strasbourg
country: France
city: Toulon
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Valenciennes
country: France
city: Vandoeuvre Les Nancy
country: France
city: Augsburg
country: Germany
city: Bad Berka
country: Germany
city: Bayreuth
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bielefeld
country: Germany
city: Bonn
country: Germany
city: Coswig
country: Germany
city: Donaustauf
country: Germany
city: Düsseldorf
country: Germany
city: Ebensfeld
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Gauting
country: Germany
city: Gerlingen
country: Germany
city: Grosshansdorf
country: Germany
city: Göttingen
country: Germany
city: Halle (Saale)
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Hannover
country: Germany
city: Karlsruhe
country: Germany
city: Kiel
country: Germany
city: Köln
country: Germany
city: Leer
country: Germany
city: Leipzig
country: Germany
city: Leverkusen
country: Germany
city: Löwenstein
country: Germany
city: Magdeburg
country: Germany
city: Mainz
country: Germany
city: Minden
country: Germany
city: Muenchen
country: Germany
city: Neuruppin
country: Germany
city: Nürnberg
country: Germany
city: Oldenburg
country: Germany
city: Rostock
country: Germany
city: Treuenbrietzen
country: Germany
city: Ulm
country: Germany
city: Villingen-Schwenningen
country: Germany
city: Wiesbaden
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city: Wolfsburg
country: Germany
city: Wuerselen
country: Germany
city: Hong Kong
country: Hong Kong
city: Hong Kong
country: Hong Kong
city: Shatin
country: Hong Kong
city: Budapest
country: Hungary
city: Mátraháza
country: Hungary
city: Pecs
country: Hungary
city: Szombathely
country: Hungary
city: Torokbalint
country: Hungary
city: Reykjavik
country: Iceland
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Jerusalem
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city: Jerusalem
country: Israel
city: Kfar-Saba
country: Israel
city: Ramat Gan
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city: Tel Aviv
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city: Zerifin
country: Israel
city: Avezzano
country: Italy
state: Abruzzo
city: Pescara
country: Italy
state: Abruzzo
city: Potenza
country: Italy
state: Basilicata
city: Rionero in Vulture
country: Italy
state: Basilicata
city: Catanzaro
country: Italy
state: Calabria
city: Avellino
country: Italy
state: Campania
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state: Campania
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country: Italy
state: Emilia-Romagna
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city: Rimini
country: Italy
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country: Italy
state: Friuli-Venezia Giulia
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state: Friuli-Venezia Giulia
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country: Italy
state: Lazio
city: Roma
country: Italy
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city: Roma
country: Italy
state: Lazio
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state: Liguria
city: La Spezia
country: Italy
state: Liguria
city: Bergamo
country: Italy
state: Lombardia
city: Cremona
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: S Fermo Della Battaglia
country: Italy
state: Lombardia
city: Sondrio
country: Italy
state: Lombardia
city: Ancona
country: Italy
state: Marche
city: Novara
country: Italy
state: Piemonte
city: Bari
country: Italy
state: Puglia
city: Brindisi
country: Italy
state: Puglia
city: San Giovanni Rotondo
country: Italy
state: Puglia
city: Cagliari
country: Italy
state: Sardegna
city: Sassari
country: Italy
state: Sardegna
city: Catania
country: Italy
state: Sicilia
city: Catania
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Taormina
country: Italy
state: Sicilia
city: Arezzo
country: Italy
state: Toscana
city: Lido Di Camaiore
country: Italy
state: Toscana
city: Pisa
country: Italy
state: Toscana
city: Camposampiero
country: Italy
state: Veneto
city: Feltre - Bl
country: Italy
state: Veneto
city: Negrar
country: Italy
state: Veneto
city: Bologna, Umbria
country: Italy
city: Forli, Emilia-Romagna
country: Italy
city: Riga
country: Latvia
city: Riga
country: Latvia
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country: Lebanon
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country: Lithuania
city: Klaipeda
country: Lithuania
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country: Lithuania
city: Chihuahua
country: Mexico
city: Leon
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Arnhem
country: Netherlands
city: Breda
country: Netherlands
city: Den Haag
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
city: Tiel
country: Netherlands
city: Zwolle
country: Netherlands
city: Bialystok
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Portugal
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country: Portugal
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country: Portugal
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country: Portugal
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country: Portugal
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country: Portugal
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country: Portugal
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country: Portugal
city: Bucharest
country: Romania
city: Cluj Napoca
country: Romania
city: Timisoara
country: Romania
city: Balashikha
country: Russian Federation
city: Engels
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Kislino, Kursk Region
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Samara
country: Russian Federation
city: Smolensk
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Tumen
country: Russian Federation
city: Tver
country: Russian Federation
city: Ulyanovsk
country: Russian Federation
city: Belgrade
country: Serbia
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Nitra
country: Slovakia
city: Poprad
country: Slovakia
city: Golnik
country: Slovenia
city: Ljubljana
country: Slovenia
city: Elche
country: Spain
state: Alicante
city: Manresa
country: Spain
state: Barcelona
city: Mataro
country: Spain
state: Barcelona
city: Sabadell
country: Spain
state: Barcelona
city: Terrassa
country: Spain
state: Barcelona
city: Santander
country: Spain
state: Cantabria
city: Palma De Mallorca
country: Spain
state: Islas Baleares
city: Alcorcon
country: Spain
state: Madrid
city: Pamplona
country: Spain
state: Navarra
city: La Laguna
country: Spain
state: Tenerife
city: Barakaldo
country: Spain
state: Vizcaya
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Girona
country: Spain
city: Huesca
country: Spain
city: La Coruña
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Salamanca
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
city: Gothenburg
country: Sweden
city: Lund
country: Sweden
city: Malmoe
country: Sweden
city: Oerebro
country: Sweden
city: Stokholm, Solna
country: Sweden
city: Umea
country: Sweden
city: Uppsala
country: Sweden
city: Aarau
country: Switzerland
city: Baden
country: Switzerland
city: Genolier
country: Switzerland
city: Locarno
country: Switzerland
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Ankara
country: Turkey
city: Gaziantep
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Sıhhiye, ANKARA
country: Turkey
city: Aberdeen
country: United Kingdom
city: Belfast
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Manchester
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Suffolk
country: United Kingdom
city: Barcelona
country: Venezuela
city: Barquisimeto
country: Venezuela
city: Porlamar
country: Venezuela
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Crino 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.