Genomic Sequencing in Determining Treatment in Patients With Metastatic Cancer or Cancer That Cannot Be Removed by Surgery

PRIMARY OBJECTIVES:

I. To assess the feasibility of implementing a Precision Oncology protocol in the treatment
of patients who undergo genomic sequencing.

SECONDARY OBJECTIVES:

I. To determine treatment response rates in patients who receive targeted treatment versus
those who do not receive targeted treatment.

II. To assess survival in patients who receive targeted treatment versus those who do not
receive targeted treatment.

III. To assess changes in patient-reported outcomes in patients who receive targeted
treatment versus those who do not receive targeted treatment.

IV. To perform exploratory statistical genetic and bioinformatics analyses using the data
derived from the genomic sequencing to catalogue additional important variants and determine
whether there are any patterns or associations among patient level risk factors, their
outcomes and genomic information that was not identified by the original genomic sequencing
analyses.

OUTLINE:

Patients receive treatment based on the results of their genomic sequencing analyses.

After completion of study treatment, patients are followed up every 2 months.

Inclusion Criteria:

- Patients with unresectable cancer for which there are genomic drivers with
corresponding Food and Drug Administration (FDA) approved or experimental drugs
available, e.g. non-small cell lung cancer; and/or patients with histologically
confirmed metastatic malignancy that have failed standard treatment or cannot tolerate
standard treatment as deemed by the treating physician

- Malignancy must be measureable as per appropriate guidelines

- Patients who are willing to provide a specimen for genomic sequencing

- Preferred method:

- Tumor cell sample available and of sufficient quantity in the Tumor Tissue
Shared Resource or patients who are willing to undergo additional tissue
collection for tumor genomic sequencing through FoundationOne; available
specimens must have been harvested within two years to be eligible

- Alternative method:

- Patients who are unwilling or unable to provide a tumor tissue sample and
who undergoes Guardant360 sequencing may be considered eligible by the
treating physician

- Patients who have already had their specimens sent for genomic sequencing are
eligible provided they have not received their sequencing results at the time of
enrollment

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Absence of clinically relevant liver or kidney failure as deemed by the treating
physician

- Ability to understand and the willingness to sign an Institutional Review Board
(IRB)-approved informed consent document

Exclusion Criteria:

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, diminished mental capacity or psychiatric illness/social situations that
would limit compliance with study requirements

- Pregnancy or lactation