Collection of Blood Samples in Patients With Non-small Cell Lung Cancer

PRIMARY OBJECTIVES:

I. To evaluate the ability of next generation sequencing (NGS) to monitor the evolution of
cancer-specific mutations in patients undergoing treatment for non-small cell lung carcinoma
and for whom the molecular profile of the tumor cells prior to treatment is known.

II. Compare the sensitivity of digital droplet polymerase chain reaction (ddPCR) to that of
NGS for detecting the appearance of EGFR T790M mutations in patients treated with an EGFR
tyrosine kinase inhibitor.

OUTLINE:

Patients undergo collection of blood samples at baseline and every 12 weeks for up to 6
times.

Inclusion Criteria:

- A diagnosis of non-small cell lung carcinoma for which the molecular profile of the
primary tumor has been obtained from a block of paraffin-embedded, formalin-fixed
tissue that remains available

- Zubrod performance status 0 or 1

- Patients must have metastatic or unresectable disease and be starting a new line of
systemic treatment at the time of enrollment; there are no constraints regarding the
time interval between the initial collection of samples for molecular profiling
studies at the time of diagnosis prior to treatment and subsequent collections of
circulating cell-free deoxyribonucleic acid (DNA) or circulating tumor cells

- Patients must have measurable disease according to Response Evaluation Criteria in
Solid Tumors (RECIST) version (v)1.1

- Ability to understand and the willingness to sign a written informed consent; Note:
There will be no discrimination between type of treatment or whether they are on
continuous versus intermittent therapy

Exclusion Criteria:

- Known severe anemia (hemoglobin [Hb] < 8g/dL)

- Patients will be excluded if trackable driver mutations are not identified in the
primary tumor tissue