Trial information
A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
Status: No longer recruiting
Protocol number: MO19390
Sponsor: Hoffmann-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: Open label study of Avastin in combination with platinum-containing chemotherapy as 1st line treatment in patients with stage IIIb/IV non-squamous NSCLC
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. Target sample size is 2000.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: bevacizumab [Avastin]
Primary outcome: 1. AEs, laboratory parameters. Time frame: Throughout study
Key secondary outcomes: 1. Duration of survival; time to disease progression. Time frame: Event driven
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: August, 2006
Trial registration date: 08/16/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Argentina
- Buenos Aires
- Chaco-Resistencia
- Córdoba
- Tucuman
Australia
- Brisbane
- Chermside
- Geelong
- Malvern
- Melbourne
- Perth
- St. Leonards
- Sydney
- Tugun
- Waratah
- Wodonga
Austria
- Bludesch
- Bregenz
- Graz
- Hall In Tirol
- Innsbruck
- Knittelfeld
- Kufstein
- Leoben
- Linz
- Natters
- Ried-Innkreis
- Salzburg
- St Pölten
- St Veit an der Glan
- Steyr
- Vöcklabruck
- Wels
- Wien
- Wiener Neustadt
- Zams
Bosnia and Herzegovina
Brazil
- Belo Horizonte
- Campinas
- Curitiba
- Florianopolis
- Fortaleza
- Goiania
- Ijuí
- Jaú
- Niteroi
- Porto Alegre
- Recife
- Ribeirão Preto
- Rio De Janeiro
- Salvador
- Santos
- Sao Paulo
- Vitoria
Canada
- Vancouver, BC
- Montreal, QC
China
- Beijing
- Guangzhou
- Hangzhou
- Hong Kong
- Shanghai
Colombia
Czech Republic
Denmark
- Århus
- Herlev
- Hillerød
- Naestved
Ecuador
Egypt
Estonia
Finland
- Helsinki
- Oulu
- Paimio
- Pori
- Tampere
France
- Aix en Provence
- Angers
- Avignon
- Besancon
- Beziers
- Bordeaux
- Brest
- Caen
- Chalon Sur Saone
- Clermont-Ferrand
- Gap
- Grenoble
- Lille
- Lyon
- Marseille
- Meaux
- Nancy
- Neuilly-Sur-Seine
- Paris
- Perpignan
- Reims
- Roubaix
- Saint Julien En Genevois
- Saint-Priest-En-Jarez
- Strasbourg
- Toulon
- Toulouse
- Valenciennes
- Vandoeuvre-Les-Nancy
Germany
- Augsburg
- Bad Berka
- Bayreuth
- Berlin
- Bielefeld
- Bonn
- Coswig
- Donaustauf
- Düsseldorf
- Ebensfeld
- Erlangen
- Essen
- Frankfurt Am Main
- Freiburg
- Gauting
- Gerlingen
- Giessen
- Göttingen
- Grosshansdorf
- Halle
- Hamburg
- Hannover
- Karlsruhe
- Kiel
- Köln
- Leer
- Leipzig
- Leverkusen
- Löwenstein
- Magdeburg
- Mainz
- Minden
- München
- Neuruppin
- Nürnberg
- Oldenburg
- Rostock
- Treuenbrietzen
- Ulm
- Villingen-Schwenningen
- Wiesbaden
- Wolfsburg
- Würselen
Hungary
- Budapest
- Mátraháza
- Pecs
- Szombathely
- Torokbalint
Iceland
Israel
- Beer Sheva
- Haifa
- Jerusalem
- Kfar Saba
- Petah Tikva
- Ramat Gan
- Tel Aviv
- Zerifin
Italy
- Ancona
- Arezzo
- Asti
- Avellino
- Avezzano
- Aviano
- Bari
- Bergamo
- Bologna
- Brescia
- Brindisi
- Cagliari
- Camposampiero
- Carpi
- Catania
- Catanzaro
- Cattolica
- Como
- Cremona
- Feltre - Bl
- Genova
- Ivrea
- La Spezia
- Lido Di Camaiore
- Messina
- Milano
- Mirano
- Modena
- Napoli
- Negrar
- Novara
- Palermo
- Pavia
- Perugia
- Pescara
- Pisa
- Potenza
- Rimini
- Rionero in Vulture
- Roma
- San Giovanni Rotondo
- Sassari
- Sondrio
- Sora
- Taormina
- Torino
- Udine
- Vecchiazzano
- Venezia
- Viagrande
- Viterbo
Latvia
Lebanon
Lithuania
Mexico
- Chihuahua
- Leon
- Mexico City
- Monterrey
- Tijuana
Netherlands
- Arnhem
- Breda
- Den Haag
- Eindhoven
- Groningen
- Haarlem
- Helmond
- Hoofddorp
- Leiden
- Nieuwegein
- Schiedam
- Spijkenisse
- Tiel
- Zwolle
Poland
- Bialystok
- Krakow
- Lublin
- Poznan
- Warszawa
- Zabrze
Portugal
- Almada
- Braga
- Cascais
- Coimbra
- Covilhã
- Lisboa
- Porto
- Santa Maria Da Feira
- Setubal
- Vila Nova De Gaia
Romania
- Bucharest
- Cluj-Napoca
- Iasi
- Timisoara
Russian Federation
- Balashikha
- Barnaul
- Ekaterinburg
- Engels
- Irkutsk
- Izhevsk
- Kazan
- Krasnodar
- Kursk
- Moscow
- Obninsk
- Samara
- Smolensk
- St Petersburg
- Stavropol
- Tumen
- Tver
- Ufa
- Ulyanovsk
Serbia and Montenegro
Slovakia
- Banska Bystrica
- Bratislava
- Kosice
- Nitra
- Poprad
Slovenia
Spain
- Alcorcon
- Alicante
- Badalona
- Barakaldo
- Barcelona
- Elche
- Girona
- Huesca
- La Coruna
- La Laguna
- Lugo
- Madrid
- Manresa
- Mataro
- Murcia
- Palma de Mallorca
- Pamplona
- Sabadell
- Salamanca
- Santander
- Terrassa
- Valencia
- Zaragoza
Sweden
- Goeteborg
- Lund
- Malmoe
- Oerebro
- Stockholm
- Umea
- Uppsala
Switzerland
Taiwan
- Taichung
- Tainan
- Taipei
- Taoyuan
Turkey
- Ankara
- Gaziantep
- Istanbul
- Izmir
United Kingdom
- Aberdeen
- Belfast
- Birmingham
- Cambridge
- Cardiff
- Chelsmford
- London
- Manchester
- Nottingham
- Peterborough
Venezuela
- Barcelona
- Barquisimeto
- Porlamar
