A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00806923

Enrollment

1044

Registered

2008-12-11

Start date

2005-02-28

Completion date

2011-02-28

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Brief summary

This 3 arm 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 non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.

Interventions

DRUGCisplatin

80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles

DRUGGemcitabine

1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles

DRUGPlacebo

iv on day 1 of each 3 week cycle until disease progression

DRUGbevacizumab [Avastin]

15mg/kg 1v on day 1 of each 3 week cycle until disease progression

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Progression-free survival	Event driven

Secondary

Measure	Time frame
Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response.	Event driven
Safety:AEs, laboratory tests, SAEs, coagulation parameters	Throughout study

Countries

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Poland, Russia, Spain, Taiwan, Thailand, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026