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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-Squamous Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Cisplatin
* Drug: Gemcitabine
* Drug: Placebo
* Drug: bevacizumab [Avastin]
* Drug: bevacizumab [Avastin]


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Cisplatin<br>* 80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles<br>Drug: Gemcitabine<br>* 1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles<br>Drug: bevacizumab [Avastin]<br>* 15mg/kg 1v on day 1 of each 3 week cycle until disease progression<br>|
| Experimental: 2<br> | Drug: Cisplatin<br>* 80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles<br>Drug: Gemcitabine<br>* 1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles<br>Drug: bevacizumab [Avastin]<br>* 7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression<br>|
| Placebo Comparator: 3<br> | Drug: Cisplatin<br>* 80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles<br>Drug: Gemcitabine<br>* 1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles<br>Drug: Placebo<br>* iv on day 1 of each 3 week cycle until disease progression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Event driven | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |