A Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-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 use, safety and tolerability of Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer.An initial cohort of patients will receive Avastin 7.5mg/kg iv every 3 weeks, in combination with concurrent thoracic radiation for 6.6 weeks and chemotherapy (cisplatin 75 mg/m2 iv and vinorelbine 15mg/m2 iv administered according to a standard treatment protocol). If no dose-limiting toxicities are observed, a second cohort of patients will receive Avastin at a dose of 15mg/kg iv every 3 weeks, in combination with a similar treatment regimen to that of the first cohort. After 5 cycles of combination treatment, Avastin monotherapy will be administered for a further 4 cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Official Title
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A Single-arm, Open-label, Multicenter Feasibility Trial of Bevacizumab Given in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Locally Advanced Unresectable Non-squamous, Non-small Cell Lung Cancer

Conditions
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Non-Squamous Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: bevacizumab [Avastin]
* Drug: cisplatin
* Drug: vinorelbine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients >=18 years with locoregional advanced unresectable non-squamous NSCLC; ECOG performance status of 0 or 1; no prior thoracic head and neck irradiation or surgical resection for current lung cancer. Exclusion Criteria: mixed, non-small cell and small cell tumors; mixed adeno-squamous carcinomas with a predominant squamous component; evidence of tumor invasion or encasement of major vessels; history of grade >=2 hemoptysis; presence of cavitations in lung lesions at baseline.

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>* 7.5mg/kg iv or 15mg/kg iv every 3 weeks<br>Drug: cisplatin<br>* 75mg/m2 iv according to a standard chemotherapy treatment protocol<br>Drug: vinorelbine<br>* 15mg/m2 iv according to a standard chemotherapy treatment protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Adverse events; clinical laboratory parameters; physical exam including vital signs; performance status. |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response |  | Week 13 and Week 22 |