1. \> 18 years of age at the time of informed consent

2. Pathologically confirmed locally advanced or metastatic NSCLC

3. ECOG Performance of less than or equal to 1 within 4 weeks prior to starting index therapy.

4. Life expectancy of more than 3 months

5. Able to understand and sign informed consent

6. Evidence of measurable disease (as assessed by the Investigator) on available imaging (e.g CT, MRI, PET)

An External Control Arm Study in Non-Small Cell Lung Cancer