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

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806923
• Other study ID #: BO17704
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2008
• Last updated: November 1, 2016
• Start date: February 2005
• Est. completion date: February 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1044
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
• Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
• Placebo
iv on day 1 of each 3 week cycle until disease progression
• bevacizumab [Avastin]
15mg/kg 1v on day 1 of each 3 week cycle until disease progression
• bevacizumab [Avastin]
7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Czech Republic,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Italy,  Poland,  Russian Federation,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		Event driven	No
Secondary	Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response.		Event driven	No
Secondary	Safety:AEs, laboratory tests, SAEs, coagulation parameters		Throughout study	No