Trial information

A Study of Avastin (Bevacizumab) in Combination With Carboplatin-Based Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer.

Status: Not yet recruiting

Protocol number: BO21015

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A randomized, open-label study to explore the correlation of biomarkers with response rate in chemo-naive patients with advanced or recurrent non-squamous non-small cell lung cancer who receive treatment with Avastin in addition to carboplatin-based chemotherapy

Brief summary: This study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 300.

Study phase: IV

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

Condition: Non-Small Cell Lung Cancer

Intervention type: Drug

Intervention name: bevacizumab [Avastin]

Primary outcome: 1. Correlation of biomarkers with response rate, as assessed by the investigator. Time frame: Event driven

Key secondary outcomes: 1. Progression-free survival, objective response rate, disease control rate, duration of response, overall survival. Time frame: Event driven 2. Adverse events, laboratory parameters. Time frame: Throughout study

Inclusion criteria:

• adult patients, >=18 years of age;
• locally advanced metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC);
• >=1 measurable tumor lesion;
• ECOG performance status 0-1.

Exclusion criteria:

• prior chemotherapy or treatment with another systemic anti-cancer agent;
• evidence of CNS metastases;
• history of grade 2 or higher hemoptysis;
• evidence of tumor invading or abutting major blood vessels;
• malignancies other than NSCLC within 5 years prior to randomization, other than adequately treated cancer in situ of cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS;
• clinically significant cardiovascular disease;
• current or recent use of aspirin (>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.

Gender: Males or Females

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

Accepts healthy volunteers: No

Anticipated start date: June, 2008

Trial registration date: 06/16/2008

Date last updated: 9/29/2008

Link to trial result

This trial will be conducted at the following locations:

Australia

• Adelaide
• Fitzroy
• Melbourne
• St. Leonards

Belgium

• Antwerpen
• Gent
• Liege

Canada

• Vancouver, BC
• Toronto, ON

China

• Hong Kong

Czech Republic

• Ostrava
• Praha

Denmark

• Odense

France

• Paris
• Rouen

Germany

• Bad Berka
• Grosshansdorf
• Hamburg
• Oldenburg

Hungary

• Budapest
• Edeleny
• Szombathely
• Torokbalint

Italy

• Milan
• Milano
• Orbassano
• Reggio Emilia
• Roma

Netherlands

• Den Haag
• Enschede
• Hoorn
• Nieuwegein
• Rotterdam

Poland

• Poznan
• Warszawa
• Zabrze

Russian Federation

• Arkhangelsk
• Chelyabinsk
• Kazan
• Krasnodar
• Moscow
• St Petersburg

Singapore

• Singapore

Spain

• Barakaldo
• Sevilla
• Valencia

Taiwan

• Changhua
• Taichung
• Taipei

United Kingdom

• Aberdeen
• Chelsmford
• London