Safety and Effect of Pertuzumab in Patients With Advanced Non-Small Cell Lung Cancer, Which Has Progressed After Prior Chemotherapy

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