Comprehensive Genomic Analysis in Tissue and Blood Samples From Young Patients With Lung Cancer

PRIMARY OBJECTIVES:

I. To perform comprehensive genomic analysis of young lung cancer patients' samples to
facilitate delivery of targeted therapies and clinical trial enrollment.

II. To characterize the impact of young age at lung cancer diagnosis on the genomic landscape
of primary lung cancer.

III. To establish a prospective registry of young lung cancer patients for both tumor and
germline next generation sequencing.

OUTLINE:

Tissue and blood samples are analyzed via next generation sequencing and whole exome
sequencing.

After completion of study, patients are followed up every 3 months for up to 3 years.

Inclusion Criteria:

- COHORT 1: LUNG CANCER PATIENTS

- Pathologically confirmed bronchogenic lung carcinoma (small cell lung cancer [SCLC] or
non-small cell lung cancer [NSCLC] of any stage) at any treatment time point

- For individuals diagnosed with advanced disease (stage IV or recurrent) enrollment
must occur within 2 years of diagnosis

- For appropriate patients (stage IV non-squamous NSCLC) epidermal growth factor
receptor (EGFR ) and anaplastic lymphoma kinase (ALK) genotyping performed by a
Clinical Laboratory Improvement Amendments (CLIA) certified laboratory is recommended
prior to participation

- Provision of written informed consent

- Willingness to undergo a single blood draw

- Individuals who are under 18 are eligible for study if they meet the defined criteria
for cohort 1; in addition, consent for participation must be given by a legal guardian
or parent

- NOTE: to be eligible for genomics, availability of 10 unstained slides (plus
hematoxylin and eosin [H&E] slide) or an adequate formalin-fixed
paraffin-embedded (FFPE) tumor block from clinically indicated interventional
procedures is required

- COHORT 2: DECEASED INDIVIDUALS

- Deceased individuals diagnosed with lung cancer at any age less than 40 may be studied
on a case by case basis depending upon Institutional Review Board (IRB) approval at a
participating institution; inclusion will require availability of adequate archived
FFPE tissue and release of tissue and records by next of kin, if available

Exclusion Criteria:

- Compromise of patient diagnosis or staging if tissue is used for research