Trial information
A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Status: No longer recruiting
Protocol number: BO18192
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study to evaluate the effect of Tarceva or placebo following platinum-based chemotherapy on overall survival and disease progression in patients with advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) who have not experienced disease progression or unacc
Brief summary: This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals. Target sample size is 850.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: erlotinib [Tarceva]
Primary outcome: 1. Progression-free survival Time frame: Event driven
Key secondary outcomes: 1. Overall survival, time to progression Time frame: Event driven
Inclusion criteria:
- adult patients >=18 years of age;
- histologically documented, locally advanced , recurrent or metastatic NSCLC;
- measurable disease;
- no disease progression after 4 cycles of platinum-based chemotherapy.
Exclusion criteria:
- unstable systemic disease;
- any other malignancies in the last 5 years.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: January, 2006
Trial registration date: 12/12/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Adelaide
- Fitzroy
- Geelong
- Melbourne
- St. Leonards
- Waratah
Austria
Belgium
Canada
- Winnipeg, MB
- Oshawa, ON
- Laval, QC
- Montreal, QC
China
- Beijing
- Guangzhou
- Shanghai
Czech Republic
Denmark
France
- Bayonne
- Brest
- Clermont-Ferrand
- Dijon
- Le Mans
- Lille
- Limoges
- Paris
- Toulouse
Germany
- Bochum
- Halle
- Villingen-Schwenningen
Greece
Hungary
- Budapest
- Deszk
- Nyiregyhaza
- Pecs
- Torokbalint
Italy
Korea, Republic of
Lithuania
Malaysia
Netherlands
- Heerlen
- Nieuwegein
- Vlissingen
New Zealand
Poland
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
- Nitra
- Poprad
Slovenia
South Africa
- Durban
- Johannesburg
- Pretoria
Spain
- La Coruna
- Oviedo
- Santander
- Zaragoza
Ukraine
United Kingdom
