A Phase II Study of Erlotinib With Bevacizumab in Chemotherapy Naïve Performance Status (PS) 2 Patients With Advanced Non-Small Cell Lung Cancer

Inclusion Criteria:

- Histological proof of non-small cell lung cancer meeting one of the following
criteria:

- stage III b with a pleural effusion

- stage IV

- Histology must not be squamous cell.

- No prior chemotherapy or hormonal therapy.

- Prior radiation therapy must be completed at least 21 days prior to being registered
for protocol therapy.

- No prior use of an epidermal growth factor receptor (EGFR) inhibitor or
antiangiogenic agent.

- No treatment with any investigational agent within 30 days prior to being registered
for protocol therapy.

- Measurable disease according to RECIST and obtained by imaging within 28 days prior
to being registered for protocol therapy.

- ECOG Performance Status of 2 in the opinion of the treating investigator.

- Age > 18 years at the time of consent.

- Females of childbearing potential and males must be willing to use an effective
method of contraception (hormonal or barrier method of birth control; abstinence)
while on treatment and for a 6 week period thereafter.

- Females of childbearing potential must have a negative pregnancy test within 7 days
prior to being registered for protocol therapy. Subjects are considered not of
child bearing potential if they are surgically sterile (they have undergone a
hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are
postmenopausal.

- Females must not be breastfeeding.

- Able to comply with study and/or follow-up procedures.

Exclusion Criteria:

- Evidence of bleeding diathesis or coagulopathy.

- Evidence of central nervous system involvement or brain metastases confirmed by head
CT or brain MRI within 28 days prior to being registered for protocol therapy.

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to registration for protocol therapy.

- Anticipation of need for major surgical procedure during the course of the study.

- Minor surgical procedures such as fine needle aspirations or core biopsies within 7
days prior to registration for protocol therapy.

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to registration for protocol therapy.

- Serious, non-healing wound, ulcer, or bone fracture.

- History of hemoptysis.

- Clinically significant infections as judged by the treating investigator.

- Other active malignancy