Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer

Since the regimen of bevacizumab, carboplatin and paclitaxel has become a standard regimen
for the treatment of advanced non-squamous NSCLC, new studies in this patient population
will have to include this as a reference arm. Addition of a fourth anti-cancer agent has now
become the new strategy to improve the outcome for advanced non-squamous NSCLC. Since the
regimen of Vorinostat, Carboplatin and Paclitaxel is already in advanced stage of
development it is important to study the safety and tolerability of Vorinostat in
combination with the three-drug regimen of Bevacizumab, Carboplatin and Paclitaxel.
Therefore, we will evaluate Vorinostat when administered in combination with the regimen of
Carboplatin, Paclitaxel and Bevacizumab for patients with previously untreated advanced
non-small cell lung cancer.

Inclusion Criteria:

- Advanced non-squamous NSCLC

- No prior chemotherapy for advanced disease

- ECOG performance status 0 or 1

- Measurable disease

- Life expectancy > 3 months

- Normal bone marrow, renal and hepatic function

- Ability to take oral medications

- Willingness to sign informed consent

Exclusion Criteria:

- History of brain metastasis

- Evidence of thromboembolic phenomenon and treatment with anticoagulants

- Pregnancy

- Uncontrolled inter-current illness

- Prior therapy with Paclitaxel