Neoadjuvant Chemo for Non-metastatic Non-small Cell Lung Cancer

Participants in this study will have a lung mass and are undergoing a procedure to determine
if they have non-small cell lung cancer that could be removed surgically. If confirmed to
have non-small cell lung cancer that can be surgically removed, he or she may be able to
continue as a possible participant in this study.

The purpose of this study is to determine whether neoadjuvant chemotherapy (chemotherapy that
is given before surgery) will improve the amount of time a participant is free from disease
in people with non-metastatic (has not spread from the original site) non-small cell lung
cancer. The chemotherapy medications that will be used in this study are cisplatin and
pemetrexed or cisplatin and gemcitabine and have been shown to be effective in patients with
non-small cell lung cancer.

Inclusion Criteria:

1. Patients ≥ 18 years of age with either a mass suspicious for or histologically
confirmed AJCC stage IB-IIIA NSCLC. For those without histologic confirmation of
NSCLC, a biopsy will be done and only those patients with histologically confirmed
NSCLC meeting all other eligibility criteria may proceed on protocol.

2. Mass must be determined to be surgically resectable

3. Eastern Cooperative Oncology Group (ECOG) performance status score < 1 and a life
expectancy >3 months.

4. Participants must have at least one evaluable lesion as defined by RECIST 1.1

5. Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5
g/dL

6. Serum creatinine ≤1.3 mg/dL (candidate for cisplatin chemotherapy), total bilirubin ≤
2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range

7. No prior chemotherapy or radiotherapy for NSCLC

8. At least 5 years from diagnosis of another cancer except treated in-situ disease or
surgically resected non-melanoma skin cancer with clear margins.

9. Willingness to provide permission to biopsy NSCLC for collection of frozen
pretreatment sample.

10. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically
sterile) must be willing to use an acceptable contraceptive method (abstinence, oral
contraceptive or double barrier method) for the duration of the study and for 30 days
following the last dose of study drug, and must have a negative urine or serum
pregnancy test within 2 weeks prior to beginning treatment on this trial

Exclusion Criteria:

1. Active clinically serious infection > CTCAE (version 4.03) Grade 2.

2. Serious non-healing wound, ulcer, or bone fracture.

3. Major contraindication to surgical resection of NSCLC

4. Inability to complete informed consent process and adhere to the protocol treatment
plan and follow-up requirements.

5. Concurrent severe illness such as active infection, or psychiatric illness/social
situations that would limit safety and compliance with study requirements.

6. Patients receiving any other investigational agents.

7. Pregnant or lactating females