A Phase II, Open-Label, Multicenter Study to Evaluate the Effect of Tumor-Based HER2 Activation on the Efficacy of rhuMAb 2C4 (Pertuzumab) in Subjects With Recurrent Non-Small Cell Lung Cancer

Inclusion Criteria:

- Signed informed consent

- Tumor accessible to biopsy and willingness to undergo tumor biopsy

- Age >= 18 years

- Recurrent, histologically documented NSCLC, i.e., squamous cell, adeno-, or large
cell anaplastic carcinoma. A cytologic diagnosis is acceptable (i.e. fine-needle
aspiration or pleural fluid cytology).

- Measurable disease with at least one lesion that can be accurately measured in at
least one dimension (bilateral dimensions should be recorded). Each lesion must be
>= 20 mm when measured by conventional techniques, including palpation, plain X-ray,
CT, and MRI, or >= 10 mm when measured by spiral CT.

- Progression of disease during, or after completion of, at least one prior
chemotherapy regimen, which should have contained either a platinum, a taxane or a
vinca alkaloid (e.g. vinorelbine). There is no upper limit on the number of prior
chemotherapy regimens each subject may have received.

- Recovery from reversible acute effects of prior chemotherapy regimens or radiotherapy
to NCI-CTC Grade <= 1 (excluding alopecia)

- ECOG performance status of 0 or 1

- Use of an effective means of contraception for men, or for women of childbearing
potential

- Absolute neutrophil count >= 1500/mL, platelet count of >= 75,000/mL and hemoglobin
>= 9 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other
approved hematopoietic growth factors; darbepoetin [Aranesp] is permitted)

- Serum bilirubin <= 1.5 x the upper limit of normal (ULN) and alkaline phosphatase,
AST, and ALT <= 2.5 x ULN (ALT, AST, and alkaline phosphatase <= 5 x ULN for subjects
with liver metastases)

- Serum creatinine <= 1.5 x ULN

- Internalized normalized ratio (INR) < 1.5 and activated partial thromboplastin time
(aPTT) < 1.5 ULN (except for subjects receiving warfarin)

Exclusion Criteria:

- Prior treatment with any HER pathway inhibitors (e.g., Herceptin [Trastuzumab],
Iressa [gefitinib], Tarceva [erlotinib hydrochloride], C225, CI1033, TAK165

- Treatment with other experimental anti-cancer agents within 4 weeks prior to Day 1

- Histologically documented bronchioalveolar carcinoma

- History or clinical or radiographic evidence of central nervous system or brain
metastases

- Ejection fraction, determined by ECHO, <50%

- Uncontrolled hypercalcemia (> 11.5 mg/dL)

- Prior exposure of > 360 mg/m2 doxorubicin or liposomal doxorubicin, > 120 mg/m2
mitoxantrone, or > 90 mg/m2 idarubicin

- Ongoing corticosteroid treatment, except for subjects who are on stable doses of < 20
mg of prednisone daily (or equivalent), or for subjects who are taking
corticosteroids for non-malignant conditions

- History of other malignancies within 5 years of Day 1 except for adequately treated
carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, or basal or
squamous cell skin cancer

- History of serious systemic disease, uncontrolled hypertension (diastolic blood
pressure > 100 mmHg on two consecutive occasions), unstable angina, congestive heart
failure, or myocardial infarction within 6 months prior to Day 1, or unstable
symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia,
i.e., atrial fibrillation, paroxysmal supraventricular tachycardia, or controlled
hypertension are eligible)

- Ongoing liver disease, including viral or other hepatitis, current alcohol abuse, or
cirrhosis

- Active infection requiring IV antibiotics

- Known human immunodeficiency virus infection

- Pregnancy or lactation

- Major surgery or significant traumatic injury within 3 weeks prior to Day 1, with the
exception of tumor biopsy for the purposes of the study

- Inability to comply with study and follow-up procedures

- Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the subject at high risk from treatment
complications