Trial information

A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Status: Recruiting

Protocol number: BO18602

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: An open-label, randomized study to evaluate the effect of Tarceva, compared with Alimta (pemetrexed) or Taxotere (docetaxel),on survival in patients with advanced, recurrent or metastatic non-small cell lung cancer who have experienced disease progression during platinum-based chemotherapy

Brief summary: This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals. Target sample size is 650.

Study phase: III

Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study

Condition: Non-Small Cell Lung Cancer

Intervention type: Drug

Intervention name: erlotinib [Tarceva]

Primary outcome: 1. Overall survival Time frame: Event driven

Key secondary outcomes: 1. PFS, time to progression, objective response, duration of response Time frame: Event driven 2. AEs, laboratory parameters Time frame: Throughout study

Inclusion criteria:

• adult patients >=18 years of age;
• histologically documented, locally advanced or recurrent or metastatic NSCLC;
• measurable disease;
• disease progression during 1-4 cycles of platinum-based chemotherapy.

Exclusion criteria:

• any other malignancies within the last 5 years;
• unstable systemic disease.

Gender: Males or Females

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

Accepts healthy volunteers: No

Anticipated start date: March, 2006

Trial registration date: 03/10/2006

Date last updated: 12/2/2008

Link to trial result

This trial is being conducted at the following locations:

Australia

• Adelaide
• Fitzroy
• Geelong
• Melbourne
• St. Leonards
• Waratah

Austria

• Innsbruck
• Klagenfurt
• Wien

Belgium

• Antwerpen

Canada

• Oshawa, ON
• Laval, QC
• Montreal, QC

Chile

• Santiago

China

• Beijing
• Guangzhou
• Shanghai

Czech Republic

• Ceské Budejovice
• Olomouc

Denmark

• Herlev
• Odense

France

• Bayonne
• Brest
• Clermont-Ferrand
• Dijon
• Le Mans
• Lille
• Limoges
• Paris
• Toulouse
• Vandoeuvre-Les-Nancy

Germany

• Bochum
• Halle
• Herne
• Villingen-Schwenningen

Greece

• Athens
• Heraklion

Hungary

• Budapest
• Deszk
• Nyiregyhaza
• Pecs
• Torokbalint

Italy

• Ancona
• Bologna
• Roma

Korea, Republic of

• Daegu
• Seoul
• Suwon

Lithuania

• Kaunas
• Klaipeda
• Vilnius

Malaysia

• Kuala Lumpur
• Penang

New Zealand

• Auckland
• Christchurch

Poland

• Lodz
• Otwock

Romania

• Bucharest
• Cluj-Napoca
• Iasi
• Timisoara

Russian Federation

• Arkhangelsk
• Balashikha
• Chelyabinsk
• Kazan
• Kirov
• Krasnodar
• Kuzmolovo
• Moscow
• Nizhny Novgorod
• Perm
• Soshi
• St Petersburg
• Yaroslavl

Slovakia

• Banska Bystrica
• Bratislava
• Nitra
• Poprad

Slovenia

• Golnik
• Ljubljana
• Maribor

South Africa

• Durban
• Johannesburg
• Pretoria

Spain

• La Coruna
• Oviedo
• Santander
• Zaragoza

Ukraine

• Uzhgorod
• Zaporozhye

United Kingdom

• Chelsmford
• Dundee
• Leicester

Venezuela

• Caracas