Inclusion Criteria:

- Pathologically/histologically confirmed non-small cell lung cancer (NSCLC), advanced
(stage IIIB w/ effusion or IV).

- Performance status of 0, 1, or 2

- Brain metastases must be clinically stable after treatment with surgery and/or
radiotherapy

- Must have received two prior systemic anti-cancer regimens for recurrent/ metastatic
disease, including one platinum-containing regimen

- Prior radiotherapy, chemotherapy and/or treatment with investigational agents is
allowed provided that the patient has recovered from the treatment-related side
effects to grade ≤1, and that at least 3 weeks has passed since the last dose

- Required laboratory values demonstrating adequate bone marrow, kidney, liver, and
blood clotting function.

- Negative pregnancy test for women of childbearing potential within 7 days prior to
study entry

- Life expectancy of 3 months or more

- Must tolerate intramuscular injections

- No prior or concurrent use of estrogen replacement therapy

- No concurrent use of cytotoxic, immunologic, hormonal, or investigational agent
intended for the antitumor treatment of NSCLC

Exclusion Criteria:

- Prior therapy with any anti-EGFR therapy such as gefitinib (IRESSA), erlotinib
(TARCEVA), vandetanib (ZD6474, ZACTIMA), or fulvestrant (FASLODEX), or an aromatase
inhibitor

- Clinically significant cardiac event such as myocardial infarction, superior vena
cava syndrome, New York Heart Association (NYHA) classification of heart disease ≥ 2
within 3 months before entry

- History of arrhythmia (multifocal premature ventricular contractions (PVCs),
bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation),
which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained
ventricular tachycardia

- Presence of left bundle branch block

- Congenital long QT syndrome, or 1st degree relative with unexplained sudden death
under 40 years of age

- History of QTc prolongation as a result from other medications that required
discontinuation of that medication

- QTc with Bazett's correction that is unmeasurable, or ≥ 480 msec on screening ECG

- Potassium <4.0 mmol/L despite supplementation, or potassium above the CTCAE grade 1
upper limit

- Serum calcium above the CTCAE grade 1 upper limit

- Magnesium below the normal range despite supplementation, or above the CTCAE grade 1
upper limit

- Hypertension not controlled by medical therapy (systolic blood pressure greater than
160 mm Hg or diastolic blood pressure greater than 100 mm Hg)

- Diagnosis of active interstitial lung disease

- Currently active diarrhea that may affect drug absorption

- Previous or current malignancies of other histologies within the last 5 years, with
the exception of cervical carcinoma in situ and basal cell or squamous cell carcinoma
of the skin

- Concomitant use of medications that are potent inducers of CYP3A4 are not allowed
within 2 weeks of study or during the study

- Any unresolved toxicity greater than CTC grade 1 from previous anti-cancer therapy

- Major surgery within 4 weeks, or incompletely healed surgical incision

- Women who are currently pregnant or breast feeding

- History of bleeding diathesis (ie, disseminated intravascular coagulation [DIC],
clotting factor deficiency)

- History of hypersensitivity to active or inactive excipients of fulvestrant (ie
castor oil or Mannitol)