Trials Today

Condition

• Non-Small Cell Lung Cancer

Eligibility

Eligible Ages

Over 18 Years

Eligible Sex

All

Accepts Healthy Volunteers

No

Criteria

For Cohort 1 Inclusion, the participant has/is:

- A known or suspected NSCLC treated with curative intent -(surgery with or without
perioperative (neoadjuvant or adjuvant) therapy).

- Suspected NSCLC - Patients with a high index of suspicion for the diagnosis of
NSCLC that is resectable may sign informed consent prior to undergoing
diagnostic procedure at the discretion of the physician. NCCN Guidelines allow
for clinical stage IA cancers to proceed directly to definitive surgery. Per
NCCN Guidelines, if a preoperative tissue diagnosis has not been obtained, then
an intraoperative diagnosis will be obtained. If a diagnosis of NSCLC is not
confirmed and/or the tumor is not resectable, then the patient will be a screen
failure.

- Undergone or planning to undergo a surgical resection - (Patients with stages I-IIIB
who are resectable - per NCCN guidelines of resectability)

- Both patients who lack molecular abnormalities and those with identified molecular
abnormalities may enroll. Choice of perioperative therapy is to follow SOC
therapeutic guidelines for the participant's molecular and PD-L1 profile.

- 18 years old or older

- Willing and able to provide informed consent

- Willing to have additional blood samples collected during routine surveillance
visits

- Must submit tumor sample representative of current disease

For Cohort 1 Exclusion, the participant has/is:

- Patients with superior sulcus tumors who are candidates for preoperative concurrent
chemoradiation.

- Stage III locally advanced and unresectable patients who are candidates for
chemoradiation followed by immunotherapy.

- It is expected that all patients on the cohort will be treated with a definitive
surgical resection. Thus, clinical stage IIIB and IIIC patients who subsequently
demonstrate pathologically confirmed N3 nodal disease or T4 N2 or 3 per any
confirmatory procedure listed in NCCN guidelines for which definitive
chemoradiotherapy rather than surgery is recommended per NCCN Guidelines are not
eligible.

- Patients who receive primary radiation (in lieu of surgery if they are not surgical
candidates).

For Cohort 2 Inclusion, the participant has/is:

- Histologically documented Stage IV NSCLC (de novo metastatic or relapse setting) not
amenable to curative surgery or radiation therapy. Palliative radiation (for
instance for impending bony fracture or to control pain) is allowed at any time
during the protocol at the physician's discretion.

- Intended to receive first line immunotherapy (as monotherapy or in combination with
chemotherapy). Patients who have had previous exposure to immunotherapy in the
neoadjuvant or adjuvant setting are allowed to enroll as long as 12 months have
elapsed since the prior exposure.

- Patients in surveillance on Cohort 1 are eligible to roll over to Cohort 2 at
the time of recurrence as long as they have had histologic confirmation of
recurrence and have been off immunotherapy for 12 months or greater and meet
all other inclusion/exclusion criteria.

- Tumors that lack activating EGFR mutations (e.g., exon 19 deletion or exon 21 L858R,
exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation) and ALK fusions. Also, per
NCCN Guideline recommended testing, tumors must also lack ROS1, BRAF, NTRK 1/2/3,
METex14 skipping mutations, and RET for which there is available front-line targeted
therapy. Only those patients with KRAS G12C mutations and ERBB2 (HER2) mutations
with no contraindications to immunotherapy (PD-L1 1) for which there are no approved
front-line targeted therapies and for whom immunotherapy would be the preferred
front-line therapy are eligible.

- Patients may be enrolled with local molecular testing and those results will be
provided.

- Patients may be enrolled with local molecular testing and those results will be
provided.

- 18 years and older

- Willing and able to provide informed consent

- Willing to have additional blood samples collected during routine surveillance
visits

- Must submit tumor sample representative of current disease

Exclusion Criteria (both Cohorts):

- Patients without a known or suspected NSCLC diagnosis, or other disease processes
such as sarcoidosis, lymphoma, or metastatic cancer from other sites.

- Not willing to have additional blood samples collected

- Patients with a secondary malignancy must have been both diagnosed > 2 years from
the lung cancer of interest and have completed all therapy for that malignancy
(including extended adjuvant therapy) > 2 years prior to diagnosis of the lung
cancer of interest with the exception of the following:

- Patients with superficial basal cell carcinoma of low-risk histology per NCCN
Guidelines (Low-risk histologic subtypes include nodular, superficial, and other
non-aggressive growth patterns such as keratotic, infundibulocystic, and
fibroepithelioma of Pinkus) and low-risk for recurrence per NCCN Guidelines
(location on trunk or extremities, size < 2 cm, primary (not recurrent), with
well-defined borders) can be included even if they are diagnosed < 2 years from the
lung cancer of interest.

- Patients with superficial squamous cell carcinoma of low-risk pathology per NCCN
Guidelines (verrucous, keratoacanthomatous) and low-risk for recurrence per NCCN
Guidelines (located on trunk or extremities; 2 cm in size; primary lesion (vs.
recurrent); well to moderately differentiated; < 2 mm thick and no invasion beyond
subcutaneous fat; negative for perineural invasion; and negative for lymphatic or
vascular involvement) can be included even if they are diagnosed < 2 years from the
lung cancer of interest.

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