Hackensack Meridian Health
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.
Subjects will be randomized 2:1 and patients in both arms will begin treatment with nivolumab 360 mg intravenously every 3 weeks and ipilimumab 1 mg/kg intravenously every 6 weeks. At five weeks of treatment, subjects will have ctDNA response evaluation with Guardant360 Response assay. At the next cycle of treatment (+/- 2 days), patients in the larger arm will receive treatment based on the Guardant360 Response assay results, as described below. Subjects will undergo ctDNA evaluation with Guardant360 Response assay 6- week post-randomization and at the time of progression. Response to therapy…
Inclusion Criteria: 1. Eligible patients will have newly diagnosed, previously untreated histologically documented Stage IV NSCLC 2. Eligible patients will be required to have positive PD-L1 expression ≥1% by IHC using Dako 22C3 assay. 3. Patients will require a baseline Guardant360 CDx test prior to enrollment 4. Patients willing to undergo serial ctDNA testing as required by protocol 5. Patients will be over the age of 18 6. Life expectancy ≥12 weeks 7. Measurable (RECIST 1.1) indicator lesion not previously irradiated, with measurable disease determined per the treating investigator. 8. Pr…
Immunotherapy
Immunotherapy
Chemotherapy
Chemotherapy
Chemotherapy
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