Pilot Study of Nilogen 3D-EX and Its Ability to Predict Therapeutic Response to Anti-PD1 or Anti-PDL1 in NSCLC

Inclusion Criteria:

In order to be eligible for participation in this trial, the subject must:

1. Be willing and able to provide written informed consent for the trial.
2. Be at least 18 years of age on the day of signing informed consent.
3. Have a histologic or cytologic diagnosis of Stage IV NSCLC.
4. Must be medically eligible to receive nivolumab, pembrolizumab or atezolizumab as the standard of care for the next line of therapy (must have previously received first line platinum doublet chemotherapy) as determined by their oncologist.
5. Have measurable disease based on RECIST 1.1 (see section 7.1 or appropriate number).
6. Be willing and medically fit to undergo a fresh (newly obtained) diagnostic biopsy of a metastatic lesion or primary site of disease before receiving nivolumab, pembrolizumab or atezolizumab. "Fresh (newly-obtained)" is defined as a specimen obtained up to 6 weeks prior to initiation of treatment with nivolumab, pembrolizumab or atezolizumab on Day 1.
7. Fit in either of these categories:

   1. Stage I-III NSCLC patients who develop metastatic disease within 6 months of receiving definitive (curative) treatment that includes platinum-based chemotherapy, and who require biopsy for either confirmation of diagnosis or further molecular or immunohistochemical testing to guide treatment.
   2. Stage IV NSCLC patients with progression of disease following platinum based chemotherapy, and who require biopsy for either confirmation of diagnosis or further molecular or immunohistochemical testing to guide treatment.
   3. Stage IV NSCLC patients who will receive nivolumab, pembrolizumab or atezolizumab as the standard of care in special circumstances (eg, when chemotherapy is contraindicated or if a patient declines to be treated with chemotherapy).
8. Be willing to undergo at least 4 fine needle aspirations for experimental purposes at the time of the standard of care biopsy.
9. Have a performance status of 0 or 1 on the ECOG Performance Scale.

Exclusion Criteria:

The subject must be excluded from participating in the trial if the subject:

1. Is currently participating in and receiving therapy as part of a different clinical trial.
2. Is not a candidate to receive nivolumab, pembrolizumab or atezolizumab as determined by the patient's oncologist.
3. Has an active infection requiring systemic therapy.
4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might; (1) confound the results of the trial, (2) that would substantially increase risk of incurring adverse events (AEs) from nivolumab, pembrolizumab or atezolizumab, (3) that would interfere with the subject's participation for the full duration of the trial, or (4) is not in the best interest of the subject to participate, in the opinion of the treating investigator.
5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
6. Is pregnant or breastfeeding.
7. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
8. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).