This clinical trial plans to assess to what extent the on-treatment circulating tumor DNA (ctDNA) can predict the subset of patients with NSCLC who will respond to immunotherapy treatment only and which patients will need both immunotherapy and chemotherapy modalities for their treatment regimen.
Eligible patients will have newly diagnosed, previously untreated histologically documented Stage IV NSCLC
Eligible patients will be required to have positive PD-L1 expression ≥1% by IHC using Dako 22C3 assay.
Patients will require a baseline Guardant360 CDx test prior to enrollment
Patients willing to undergo serial ctDNA testing as required by protocol
Patients under the age of 18
Inability to provide informed consent by either the patient or the authorized representative
Patients with known EGFR, ALK, ROS1, MET, and RET oncogenic driver alterations that have approved first-line targeted therapies are excluded from the study (All patients must have a tissue or blood-based testing to identify these driver alterations)
Patients with no detectable ctDNA or ctDNA VAF ≤ 0.3% on Guardant360 CDx at baseline
Hackensack Meridian Health
Lead sponsor
MedSIR
Collaborator