Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy

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.

Trial Details

NCT ID

NCT05715229

Phase

PHASE2

Sponsor

Hackensack Meridian Health

Status

RECRUITING

Cancer Type

Non-Small Cell (NSCLC) Lung Cancer

Interventions

Nivolumab
Ipilimumab
Carboplatin
Paclitaxel
Pemetrexed

Locations (sample)

Washington D.C., District of Columbia, United States|38.89511,-77.03637
Hackensack, New Jersey, United States|40.88593,-74.04347
Neptune City, New Jersey, United States|40.20011,-74.02792

Key Eligibility Criteria

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

For full eligibility, visit ClinicalTrials.gov.

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