Phase II Study of Abraxane and Gemicitabine in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer Progressing After First-Line Platinum-Based Chemotherapy

Inclusion Criteria:

- Histologic or cytologic diagnosis of adenocarcinoma non-small cell lung cancer

- Stage IV non-small cell lung cancer or recurrent disease which cannot be approached
with curative intent.

- First-line treatment with a standard platinum doublet chemotherapy regimen
(carboplatin or cisplatin at standard dosing plus one of the following drugs at
standard dosing: paclitaxel, docetaxel, vinblastine, vinorelbine, pemetrexed, or
etoposide). Patients who received platinum-based chemotherapy for localized lung
cancer (either adjuvant chemotherapy following surgery or chemotherapy given in
conjunction with definitive radiation) are eligible if their cancer has recurred
within 6 months of platinum-based chemotherapy.

- Must have recovered from toxic effects of prior chemotherapy

- ECOG performance status of 0-1

- Life expectancy of at least 12 weeks

- Age 18 or greater

- Must have measurable disease defined as at least one lesion that can be accurately
measured in at least one dimension (longest diameter to be recorded as > 20 mm with
conventional techniques or > 10 mm with spiral CT scanning).

- Patients with prior malignancies are allowed, provided they have been treated with
curative intent and have no evidence of active disease.

- Patients must be capable of giving informed consent and be willing and able to comply
with scheduled visits, treatment plan and laboratory testing.

- Bilirubin < 1.5 mg/dL

- Patients must have adequate liver function: AST and ALT < 2.5 X upper limit of normal,
alkaline phosphatase < 2.5 X upper limit of normal, unless bone metastasis is present
in the absence of liver metastasis

- Patients must have adequate bone marrow function: Platelets >100,000 cells/mm3,
Hemoglobin > 9.0g/dL and ANC > 1,500 cells/mm3

- Patients must have adequate renal function: creatinine <1.5 mg/dL

- Women of childbearing potential and sexually active males must use an effective
contraception method during treatment and for three months after completing treatment

- Negative serum β-hCG pregnancy test at screening for patients of childbearing
potential.

- Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)

Exclusion Criteria:

- Patients with EGFR or EML4-ALK mutations

- ECOG performance status >1

- Patients previously treated with gemcitabine or Abraxane

- Uncontrolled intercurrent illness including, but not limited to: uncontrolled ongoing
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Known HIV or Hepatitis C

- Untreated central nervous system metastases. Patients are eligible if they are
clinically stable, off all steroids after cranial irradiation (whole brain radiation
therapy, focal radiation therapy, stereotactic radio surgery) ending at least 2 weeks
prior to enrollment, or after surgical resection performed at least 2 weeks prior to
enrollment.

- Concurrent treatment with other anticancer therapy, including other chemotherapy,
immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy,
or an investigational agent

- Pregnant or breast-feeding patients, as chemotherapy is thought to present substantial
risk to the fetus/infant. Men and women of reproductive potential may not participate
in this study unless they have agreed to use an effective contraceptive method while
in this study. (Postmenopausal woman must have been amenorrheic for at least 12 months
to be considered of non-childbearing potential). Patients must agree to continue
contraception for 3 months from the date of the last study drug administration