Trial information
A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Status: No longer recruiting
Protocol number: BO17704
Sponsor: Hoffmann-La Roche Ltd/Inc/AG/Roche Global Development
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of the effect of Avastin plus cisplatin and gemcitabine or placebo plus cisplatin and gemcitabine on progression-free survival in treatment-naïve patients with advanced or recurrent non-squamous NSCLC
Brief summary: This study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous NSCLC who have not received prior chemotherapy. The anticipated time of study treatment is 1-2 years, and the target sample size is 500+ individuals.
Target sample size is 1050.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Placebo; Parallel; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: bevacizumab[Avastin]
Primary outcome: 1. Progression-free survival
Key secondary outcomes: 1. Efficacy: Duration of overall survival, time to treatment failure,, response rate, and duration of response. Safety: Adverse events, laboratory tests, serious adverse events, and coagulation parameters
Inclusion criteria:
- adult patients, >=18 years of age;
- documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;
- adequate liver and kidney function;
- women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment.
Exclusion criteria:
- prior chemotherapy or treatment with another systemic cancer therapy;
- surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment;
- brain metastasis or spinal cord compression;
- fertile men, and women of childbearing potential, not using adequate contraception;
- treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2005
Trial registration date: 06/24/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Argentina
- Bahia Blanca
- Buenos Aires
- Mendoza
Australia
- Adelaide
- Brisbane
- Canberra
- Melbourne
- Parkville
- Perth
- Sydney
- Tugun
- Wollongong
Belgium
- Haine-Saint-Paul
- Leuven
- Liege
Brazil
- Porto Alegre
- Rio De Janeiro
Bulgaria
Canada
- Calgary, AB
- Edmonton, AB
- Victoria, BC
- Mississauga, ON
- Toronto, ON
- Weston, ON
- Greenfield Park, QC
- Montreal, QC
- Sainte-Foy, QC
China
Czech Republic
- Ostrava
- Praha
- Usti Nad Labem
France
Germany
- Berlin
- Essen
- Gauting
- Grosshansdorf
- Mannheim
Greece
- Alexandroupolis
- Athens
- Thessaloniki
Hungary
- Budapest
- Szekesfehervar
- Szombathely
- Zalaegerszeg
Israel
- Kfar Saba
- Petah Tikva
- Ramat Gan
- Tel Aviv
Italy
- Candiolo
- Catania
- Genova
- Milano
- Napoli
- Parma
- Perugia
- Roma
- Rozzano
Poland
Russian Federation
- Balashikha
- Moscow
- St Petersburg
Spain
- Alicante
- Barakaldo
- Barcelona
- Girona
- La Laguna
- Madrid
- Malaga
- Sevilla
- Valencia
Taiwan
Thailand
United Kingdom
- Guildford
- London
- Manchester
- Sheffield
- Sutton
- Yeovil
