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: 11/21/2008

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
• Linz
• Natters
• Ried-Innkreis
• Salzburg
• St Pölten
• St Veit an der Glan
• Steyr
• Vöcklabruck
• Wels
• Wien
• Wiener Neustadt
• Zams

Bosnia and Herzegovina

• Banja Luka
• Sarajevo

Brazil

• Belo Horizonte
• Campinas
• Curitiba
• 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

• Bogota
• Cali
• Manizales

Czech Republic

• Brno
• Plzen
• Praha

Denmark

• Århus
• Herlev
• Hillerød
• Naestved

Ecuador

• Guayaquil
• Quito

Egypt

• Cairo

Estonia

• Tallinn
• Tartu

Finland

• Helsinki
• Oulu
• Paimio
• Pori
• Tampere

France

• Aix en Provence
• 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
• 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

• Reykjavik

Israel

• Beer Sheva
• Haifa
• Jerusalem
• Kfar Saba
• Petah Tikva
• Ramat Gan
• Tel Aviv
• Zerifin

Italy

• Ancona
• Arezzo
• Avellino
• Avezzano
• Aviano
• Bari
• Bergamo
• Bologna
• Brindisi
• Cagliari
• Camposampiero
• Carpi
• Catania
• Catanzaro
• Como
• Cremona
• Feltre - Bl
• Genova
• La Spezia
• Lido Di Camaiore
• Milano
• Modena
• Napoli
• Negrar
• Novara
• Palermo
• Pavia
• Perugia
• Pescara
• Pisa
• Potenza
• Rimini
• Rionero in Vulture
• Roma
• San Giovanni Rotondo
• Sassari
• Sondrio
• Sora
• Taormina
• Udine
• Vecchiazzano
• Viterbo

Latvia

• Riga

Lebanon

• Beirut

Lithuania

• Kaunas
• Klaipeda
• Vilnius

Mexico

• Chihuahua
• Leon
• Mexico City
• 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

• Belgrade

Slovakia

• Banska Bystrica
• Bratislava
• Kosice
• Nitra
• Poprad

Slovenia

• Golnik
• Ljubljana

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

• Aarau
• Baden
• Locarno

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