Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-small Cell Lung Cancer

PRIMARY OBJECTIVES:

I. To evaluate the overall response rate of weekly nab-paclitaxel (paclitaxel
albumin-stabilized nanoparticle formulation) in patients with advanced non-small cell lung
cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations following front-line
therapy with EGFR tyrosine kinase inhibitors (TKI).

SECONDARY OBJECTIVES:

I. To evaluate the safety profile of weekly nab-paclitaxel in patients with advanced NSCLC
with EGFR mutations following front-line therapy with an EGFR TKI.

II. To evaluate the time-to-progression and overall survival.

OUTLINE:

Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV)
over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks and then every 3
months thereafter.

Inclusion Criteria:

- Pathologically confirmed non-small cell lung cancer with documented EGFR mutation in
tumor deoxyribonucleic acid (DNA) or complete/partial response to first line EGFR
tyrosine kinase inhibitors with > or = to 6 months duration of response in patients
who do not have a confirmed EGFR mutation

- At least one site of measurable disease as determined by the Investigator, using
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

- Progressive disease with radiographic evidence of disease progression per investigator
assessment during therapy with an EGFR tyrosine kinase inhibitor in the metastatic
setting; patients may continue EGFR inhibitor therapy throughout the screening period
until the day prior to nab-paclitaxel treatment initiation

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at the time of
informed consent

- Platelet count >= 100,000/uL

- Absolute neutrophil count >= 1,500/uL

- Hemoglobin >= 9 g/dL

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = < 2.5 times
upper limit of normal

- Alkaline phosphatase =< 2.5 times upper limit of normal, unless bone metastasis is
present in the absence of liver metastasis

- Bilirubin =< 1.5 mg/dL

- Creatinine =< 1.5 mg/dL

- Women of child-bearing potential (WOCP) and sexually active men must agree to use
adequate contraception (hormonal or barrier method of birth control or abstinence)
prior to study entry, during treatment and for three months after completing treatment

- Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at
screening for patients of childbearing potential

- Life expectancy of > 12 weeks

- Signed and dated informed consent document indicating that the patient has been
informed of all the pertinent aspects of the trial prior to enrollment

Exclusion Criteria:

- Prior conventional cytotoxic chemotherapy for metastatic or recurrent disease; prior
adjuvant, neoadjuvant or chemoradiotherapy for NSCLC is permitted, provided at least 6
months elapsed prior to documented metastatic recurrence

- A single dose of a platinum doublet discontinued due to intolerability without
evidence of disease progression is permitted

- Patient is < 5 years free of another primary malignancy, except: a) if the other
malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other
primary malignancy is not considered clinically significant and is requiring no active
intervention

- Progressive or symptomatic central nervous system (CNS) metastases; patients with
known brain metastasis must have stable disease following treatment with surgery,
radiation or both; in addition, they must be off corticosteroids

- Radiotherapy within 7 days of study treatment

- Peripheral neuropathy grade 2 or greater

- Grade III/IV congestive heart failure, as defined by New York Heart Association (NYHA)
criteria, or myocardial infarction within 6 months

- Any serious or uncontrolled concomitant disorder that, in the opinion of the
investigator, would compromise the patient's ability to complete the study

- Patient has known chronic liver disease, e.g. diagnosis of chronic active hepatitis or
cirrhosis

- Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study
treatment; placement of vascular access device and biopsies allowed and is not
considered major or minor surgery

- Patient with any significant history of non-compliance to medical regimens or with
inability to grant reliable informed consent

- Pregnant or breast feeding females