Roche trials database

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:

Completed

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 303.

Study phase:

II

Study type:

Interventional; Treatment; Randomized; Active; Parallel; Safety/efficacy study

Conditions:

• 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:

September, 2008

Trial registration date:

27.03.2008

Date last updated:

26.02.2013

This trial was conducted at the following locations:

Australia

• ADELAIDE
• FITZROY
• MELBOURNE
• ST. LEONARDS

Belgium

• ANTWERPEN
• LIEGE

Canada

• VANCOUVER, BC
• TORONTO, ON

Czech Republic

• OSTRAVA
• PRAHA

DENMARK

• Odense

France

• PARIS
• ROUEN

Germany

• BAD BERKA
• GROSSHANSDORF
• HAMBURG
• OLDENBURG

Hong Kong

• HONG KONG

Hungary

• BUDAPEST
• EDELENY
• SOPRON
• SZOMBATHELY
• TOROKBALINT

Italy

• MILAN
• MILANO
• ORBASSANO
• ROMA

Netherlands

• DEN HAAG
• ENSCHEDE
• HOORN
• NIEUWEGEIN
• ROTTERDAM

Poland

• POZNAN
• WARSZAWA
• ZABRZE

Russian Federation

• ARKHANGELSK
• CHELYABINSK
• KAZAN
• KRASNODAR
• MOSCOW
• ST PETERSBURG

RUSSIAN FEDERATION

• KAZAN

Spain

• BARAKALDO
• SEVILLA
• VALENCIA

Taiwan

• CHANGHUA
• TAICHUNG
• TAIPEI

United Kingdom

• ABERDEEN
• CHELSMFORD

UNITED KINGDOM

• London

Link to trial result