Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients

The goal of this study is two-fold: 1) Demonstrate feasibility of detection of EML4-ALK fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis, using an institutionally accepted assay; 2) Demonstrate feasibility of detection of T790M EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis, using an institutionally accepted assay.

Primary outcomes

• ALK mutation by tissue assay. [Two years]: Patients found to be positive for ALK mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing.
• T790M EGFR mutation by tissue assay [Two years]: Patients found to be positive for T790M EGFR mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

1. Participants must have histologically confirmed NSCLC, stage IIIB- IV, and have tested positive for the presence of EML4-ALK on tissue specimen, fresh or archived, using an institutionally accepted assay.
2. Age of 18 years or older.
3. Participants are being considered for ALK-directed therapy or have progressed on EGFR TKI treatment.
4. Participants must have hemoglobin > 10 mg/dL.
5. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

1. Hepatitis (all types) in patient's medical record
2. HIV documented in patient's medical record
3. Hemoglobin < 10 mg/dL
4. Less than 18 years of age
5. Histologically confirmed NSCLC Stage I-IIIA
6. Tested negative for the presence of EML4-ALK and T790M EGFR on tissue

• Roger Tun, Study director, Exosome Diagnostics, Inc.