Role of Circulating Tumor DNA (ctDNA) From LIquid Biopsy in Early Stage NSCLC Resected Lung Tumor Investigation

Every type of cancer is associated with changes in genes and protein structure or function in
the body known as "biomarkers". These biomarkers can help diagnose cancer, as well as to
track the disease and response to treatment. Over the last 10 years, technology has led to
the identification of many cancer biomarkers; the use of cancer biomarkers has become an
important part in the treatment and management of cancer.

For solid tumors, biomarker testing is usually done on the tumor tissue from a biopsy or
surgery. Although testing tumor tissue provides a lot of information, there are some
challenges with the process. First, tumor cells can be different even within small tumors. To
overcome this, the pathologist (doctor that examines tumor tissue) needs to test cells from
different parts of the tumor. Often, there may not be enough of the tissue to test for
biomarkers. In addition, tumor cells change when the patient undergoes treatment and there
might be a need to repeat biopsies. Sometimes it may not be possible to repeat a biopsy to
study the changes in biomarkers because some patients cannot have a repeat biopsy done
safely.

There are many advantages to tracking biomarkers in the blood instead of on tissue. We can
study changes in biomarkers more often (because it is a blood draw), and therefore will be
able to determine how your treatment is working, learn if the cancer is coming back, or find
drugs that may target the changed tumor cells.

The purpose of this research study is to learn more about changes in cell-free tumor DNA in
blood samples, also known as a liquid biopsy, as they relate to treatment and response to
treatment. Cell-free tumor DNA is genetic material that is released into your bloodstream
from tumor cells as they die. Genes are a unique combination of molecules (called DNA) that
are found in all human cells. In some cases, these genes may be changed in cancer and tumor
cells. These changes, or tumor markers are substances produced by cancer cells that are found
in the blood, body fluids or tissues, and may be made of DNA, RNA, proteins, cells or
components of cells. In the future, the "markers" may help doctors decide which treatments
could be most beneficial for NSCLC. Tumor markers may be used to help predict a response to
certain cancer treatments and to check how the patiet's type of cancer responds to the
treatment.

Inclusion Criteria:

1. Male or female aged 18 years and over

2. Planned surgical resection of NSCLC, stage IB ≥ 4 cm, II or IIIA according to the 8th
edition of TNM classification16.

1. Cohort #1: Neoadjuvant Therapy - For patients who will receive neoadjuvant
therapy, enrollment occurs prior to the initiation of treatment. Patients
undergoing neoadjuvant therapy who achieved tumor reduction, are eligible based
on baseline radiographic staging.

2. Cohort #2: Pre-Surgery - For patients identified prior to planned surgical
resection, enrollment occurs within 30 days of the planned surgery. Eligibility
is based on surgical pathology.

3. Cohort #3: Post-Surgery - For patients identified post-surgical resection,
enrollment occurs prior to the initiation of adjuvant therapy. Eligibility is
based on surgical pathology.

3. Patients with positive margins and those requiring adjuvant radiation therapy are
eligible.

4. Patients with a secondary malignancy that was treated with curative intent and without
evidence of relapse for at least 5 years.

5. Willingness to undergo all study collection procedures and follow up.

6. Provision of written informed consent

Exclusion Criteria:

1. Male or female aged less than 18 years

2. NSCLC disease other than stated above

3. Patients with a secondary malignancy that was not treated with curative intent or has
had a disease relapse in the past 5 years.

4. Unwilling to undergo all study collection procedures and follow up.

5. Unable or unwilling to provide consent.