Trial information

An Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Status: No longer recruiting

Protocol number: MO18109

Sponsor: F Hoffmann-La Roche Ltd/Inc/AG

Company division: Pharmaceutical

Official Scientific Title: An open-label, expanded-access study of the effect of Tarceva on treatment response in patients with advanced stage IIIB/IV non-small-cell lung cancer

Brief summary: This study will provide treatment with Tarceva to patients with advanced NSCLC who have received >=1 course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study. The anticipated time on study treatment is as long as the patient is, in the investigator's opinion, benefiting from the therapy and the target sample size is 500+ individuals. Target sample size is 7041.

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: erlotinib[Tarceva]

Primary outcome: 1. Patient access

Key secondary outcomes: 1. Efficacy: Response rate, time to progression, survival Safety: Serious adverse events, adverse events leading to premature withdrawal, rash related to therapy, laboratory assessments

Inclusion criteria:

• adult patients >=18 years of age;
• histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent NSCLC;
• previous treatment with <=2 prior chemotherapy regimens.

Exclusion criteria:

• previous systemic anti-cancer therapy with HER1/EGFR inhibitors;
• inability to take oral medication;
• any other malignancies within 5 years.

Gender: Males or Females

Age limits: Min: 18 Years Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: November, 2004

Trial registration date: 06/24/2005

Date last updated: 8/19/2008

Link to trial result

This trial was conducted at the following locations:

Albania

• Tirana

Argentina

• Buenos Aires
• Córdoba
• La Plata
• Salta
• Santa Fe

Australia

• Adelaide
• Chermside
• Frankston
• Fremantle
• Geelong
• Malvern
• Melbourne
• Perth
• St. Leonards
• Sydney
• Tugun
• Waratah
• Wodonga
• Wollongong

Austria

• Grimmenstein
• Innsbruck
• Klagenfurt
• Kufstein
• Leoben
• Linz
• Natters
• Salzburg
• Vöcklabruck
• Wels
• Wien
• Zams

Belgium

• Aalst
• Antwerpen
• Arlon
• Baudour
• Blankenberge
• Borgerhout
• Boussu
• Brasschaat
• Bruxelles
• Charleroi
• Edegem
• Genk
• Gent
• Gilly
• Godinne
• Gosselies
• Haine-Saint-Paul
• Hasselt
• Kortrijk
• Libramont
• Liege
• Mons
• Namur
• Oostende
• Ottignies
• Oudenaarde
• Roeselare
• Sint-Niklaas
• Tielt
• Tournai
• Turnhout
• Wilrijk

Bosnia and Herzegovina

• Banja Luka
• Sarajevo

Brazil

• Belo Horizonte
• Brasilia
• Campinas
• Caxias do Sul
• Curitiba
• Fortaleza
• Ijuí
• Jaú
• Porto Alegre
• Rio De Janeiro
• Salvador
• Santos
• Sao Paulo
• Sorocaba

Bulgaria

• Plovdiv
• Sofia
• Varna

Chile

• Santiago

China

• Beijing
• Chengdu
• Guangzhou
• Hangzhou
• Harbin
• Hong Kong
• Nanjing
• Shanghai
• Tianjin
• Wuhan

Colombia

• Bogota
• Cali

Croatia

• Zagreb

Czech Republic

• Brno
• Hradec Kralove
• Olomouc
• Plzen
• Praha

Ecuador

• Guayaquil
• Quito

Egypt

• Cairo
• Giza

Estonia

• Tallinn
• Tartu

Finland

• Haemeenlinna
• Helsinki
• Joensuu
• Kuopio
• Oulu
• Pori
• Turku
• Vaasa

Germany

• Amberg
• Augsburg
• Aurich
• Bad Berka
• Berlin
• Bielefeld
• Bonn
• Celle
• Dortmund
• Dresden
• Essen
• Flensburg
• Frankfurt Am Main
• Freiburg
• Gauting
• Gerlingen
• Giessen
• Grosshansdorf
• Halle
• Hamburg
• Heidelberg
• Herne
• Homburg
• Kassel
• Kiel
• Koblenz
• Köln
• Leipzig
• Leverkusen
• Lostau
• Löwenstein
• Mainz
• Mannheim
• Minden
• Mönchengladbach
• München
• Münchengladbach
• Münster
• Neuruppin
• Nürnberg
• Oldenburg
• Osnabrück
• Rostock
• Saarbrücken
• Trier
• Ulm
• Wangen
• Wiesbaden
• Wuppertal
• Würselen

Greece

• Athens
• Haidari
• Heraklion
• Neo Faliro
• Thessaloniki

Guatemala

• Guatemala City

Hungary

• Budapest
• Deszk
• Kecskemet
• Mátraháza
• Nyiregyhaza
• Pecs
• Torokbalint

India

• Bangalore
• New Delhi
• Pune
• Vellore

Indonesia

• Jakarta

Ireland

• Cork
• Dublin

Israel

• Ashkelon
• Beer Sheva
• Haifa
• Holon
• Jerusalem
• Kfar Saba
• Nahariya
• Petah Tikva
• Ramat Gan
• Rehovot
• Safed
• Tel Aviv
• Zerifin

Italy

• Ancona
• Avellino
• Aviano
• Bari
• Benevento
• Bergamo
• Bollate
• Bologna
• Brescia
• Candiolo
• Catania
• Catanzaro
• Cosenza
• Cuneo
• Fabriano
• Feltre - Bl
• Firenze
• Genova
• Lido Di Camaiore
• Livorno
• Messina
• Milano
• Modena
• Napoli
• Noale (Ve)
• Nuoro
• Orbassano
• Palermo
• Parma
• Pavia
• Perugia
• Pescara
• Pisa
• Rionero in Vulture
• Roma
• Salerno
• San Giovanni Rotondo
• Sassari
• Siena
• Sondrio
• Taormina
• Torino
• Trento
• Udine
• Vecchiazzano

Korea, Republic of

• Bundang City
• Busan
• Cheonan
• Daegu
• Daejeon
• Gwangju
• Iksan
• Incheon
• Kyunggi Do
• Pusan
• Seoul
• Suwon

Latvia

• Riga

Lithuania

• Kaunas
• Vilnius

Macedonia, The Former Yugoslav Republic of

• Skopje

Malaysia

• Kuala Lumpur

Mexico

• Acapulco
• Chihuahua
• Guadalajara
• Juarez
• Leon
• Madero
• Matamoros
• Merida
• Mexicali
• Mexico City
• Monterrey
• Obregon
• Puebla
• San Luis Potosi
• Tampico
• Tijuana
• Toluca
• Torreon
• Zapopan

Netherlands

• Alkmaar
• Amersfoort
• Amstelveen
• Amsterdam
• Arnhem
• Assen
• Beverwijk
• Boxmeer
• Breda
• Capelle Ad Yssel
• Den Haag
• Drachten
• Eindhoven
• Enschede
• Groningen
• Haarlem
• Harderwijk
• Heerlen
• Hengelo
• Hoofddorp
• Leiden
• Leiderdorp
• Maastricht
• Nieuwegein
• Nijmegen
• Roermond
• Rotterdam
• 'S Hertogenbosch
• Sliedrecht
• Venlo
• Vlissingen
• Zaandam
• Zwolle

New Zealand

• Christchurch
• Hamilton
• Palmerston North
• Wellington

Panama

• Panama City

Peru

• Callao
• Lima

Poland

• Gdansk
• Lublin
• Olsztyn
• Poznan
• Warszawa
• Wroclaw
• Zabrze

Portugal

• Lisboa
• Porto
• S Martinho Do Bispo
• Setubal
• Vila Nova De Gaia

Romania

• Alba Iulia
• Baia Mare
• Bucharest
• Cluj-Napoca
• Oradea
• Sibiu
• Suceava
• Timisoara

Russian Federation

• Kazan
• Krasnodar
• Moscow
• Obninsk
• Smolensk
• St Petersburg
• Ufa
• Volgograd

Saudi Arabia

• Riyadh

Serbia and Montenegro

• Belgrade
• Novi Sad

Slovakia

• Banska Bystrica
• Bratislava
• Kosice
• Nitra
• Poprad

Slovenia

• Ljubljana

Sweden

• Falun
• Goeteborg
• Linkoeping
• Lund
• Malmoe
• Stockholm
• Uppsala

Switzerland

• Aarau
• Baden
• Chur
• Locarno
• Luzern
• Zürich

Taiwan

• Changhua
• Kaohsiung
• Taichung
• Tainan
• Taipei
• Taoyuan

Thailand

• Bangkok

Turkey

• Ankara
• Istanbul
• Izmir

Uruguay

• Montevideo

Venezuela

• Caracas