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

Phase 3

Completed

• Conditions: Non-Squamous Non-Small Cell Lung Cancer
• Interventions: Drug: Cisplatin; Drug: Gemcitabine; Drug: bevacizumab [Avastin]; Drug: Placebo

• Registration Number: NCT00806923
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-10
• Study First Posted: 2008-12-11
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1044

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	bevacizumab [Avastin]	-
2	Gemcitabine	-
3	Gemcitabine	-
1	Gemcitabine	-
1	bevacizumab [Avastin]	-
2	Cisplatin	-
3	Placebo	-
1	Cisplatin	-
3	Cisplatin	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival	Event driven

Secondary Outcome Measures

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