A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Official Title
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An Open Label Study of the Safety of First-line Treatment With Avastin in Combination With Cisplatin-gemcitabine or Carboplatin-paclitaxel in Patients With Advanced or Recurrent Squamous Non-small Cell Lung Cancer, Who Are Considered to be at High Risk of Pulmonary Haemorrhage

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: bevacizumab [Avastin]
* Drug: Platinum-based chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, >=18 years of age; documented squamous non-small cell lung cancer; stage IIIb with pleural or pericardial effusion, stage IV, or recurrent disease; suitable for platinum-based treatment as first line chemotherapy. Exclusion Criteria: prior systemic anti-tumor therapy; prior radiotherapy for treatment of patient's current stage of disease; other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix; major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: bevacizumab [Avastin]<br>* 15mg iv on day 1 of each 3 week cycle<br>Drug: Platinum-based chemotherapy<br>* As prescribed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of grade >=3 Avastin-related pulmonary hemorrhage |  | After a maximum of 12 months treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response, duration of response, progression-free survival. |  | Event driven | 
| AEs, laboratory parameters, coagulation parameters. |  | Throughout study |