Next-generation Sequencing of Small Cell Lung Cancer to Identify Actionable Targets for Treatment

Participants will be consented into the study after they are found to meet the study
inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the
participant. Blood will be sent to Ashion for DNA extraction. Tumor specimens will be shipped
to Ashion for DNA and RNA extraction. Ashion will process the samples for DNA and RNA
Sequencing in their CLIA certified laboratory. A portion of the nucleic acid will be stored
in Ashion and used to confirm actionable targets. Results will be submitted to the physician
for possible inclusion in the treatment regimen. After sequencing analysis has been
performed, a report will be provided to the treating oncologist. The PI and the treating
oncologist may review the results to identify potential treatment. The treating oncologist
may use this information at their discretion, and is not required to treat the patient based
on the targets identified by the GWS analysis.

Inclusion Criteria:

- Patients must understand the rigors of the study and provide written informed consent
and HIPAA authorization prior to initiation of any study procedures

- Life expectancy > 3 months

- Karnofsky Performance Status ≥ 70

- Diagnosis of histological or cytologically confirmed advanced, incurable SCLC, which
has progressed on one or more prior chemotherapeutic, hormonal, or biological regimens
for advanced SCLC

- Age ≥ 18 years

- Adequate organ and bone marrow function, defined as: Bone marrow: absolute neutrophil
count (ANC) ≥ 1.5 x 109/L; hemoglobin > 9 g/dL; platelets > 100 x 109/L Renal:
creatinine clearance ≥ 50 mL/min (calculated according to Cockroft and Gault) or
creatinine ≤ 1.5 mg/dL Hepatic: bilirubin ≤ 1.5 x the upper limit of normal (ULN);
aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) ≤ 2.5 x ULN
(or ≤ 5 x ULN if due to underlying liver metastases); internation normalized value for
prothrombin time (INR) ≤ 1.5 x ULN (except in the case of anticoagulation therapy),
albumin ≥ 2.0

- Good medical candidate for and willing to undergo a biopsy or surgical procedure to
obtain tissue, which may or may not be part of the patient's routine care for their
malignancy.

Exclusion Criteria:

- Symptomatic CNS metastasis. Patients with a history of CNS metastases, who have been
treated, must be stable without symptoms for 4 weeks after completion of treatment,
with image documentation required, and must be either off steroids or on a stable dose
of steroids for ≥ 2 weeks prior to enrollment

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
serious infection, symptomatic congestive heart failure, unstable angina pectoris,
unstable cardiac arrhythmias, psychiatric illness, or situations that would limit
compliance with the study requirements or the ability to willingly give written
informed consent

- Known HIV, HBV, or HCV infection requiring antiviral therapy.

- Pregnant or breastfeeding patients or any patient of childbearing potential not using
adequate contraception.

- Tumor inaccessible for biopsy