Health TrialsbyHealthPanel

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

ConditionCarcinoma, Non-Small-Cell Lung
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHackensack Meridian Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nivolumab

    Drug

    Immunotherapy

  • Ipilimumab

    Drug

    Immunotherapy

  • Carboplatin

    Drug

    Chemotherapy

  • Paclitaxel

    Drug

    Chemotherapy

  • Pemetrexed

    Drug

    Chemotherapy

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Arm AActive comparator 5 interventions
Group B: Arm BOther 2 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

To compare progression free survival in patients with on-treatment-ctDNA guided therapy continuation or escalation by addition of platinum-doublet chemotherapy to therapy continuation with Nivolumab-Ipilimumab regardless of on-treatment-ctDNA results.

Time frame
Time from randomization to objective disease progression, or death from any cause, whichever first, up to 36 months

Secondary outcomes

1

Progression Free Survival on Subsequent line of therapy (PFS2)

To compare progression free survival on subsequent line of therapy (PFS2) between patients with on-treatment-ctDNA guided therapy continuation or escalation by addition of platinum-doublet chemotherapy to therapy continuation with Nivolumab-Ipilimumab regardless of on-treatment-ctDNA results

Time frame
Duration of time from randomization to second objective disease progression, or death from any cause, whichever first, up to 36 months
2

Overall Survival

To compare overall survival (OS) in patients with on-treatment-ctDNA guided therapy continuation or escalation by addition of platinum-doublet chemotherapy to therapy continuation with Nivolumab-Ipilimumab regardless of on-treatment-ctDNA results

Time frame
Duration of time from first treatment to time of death, up to 36 months
3

Objective Response Rate

To compare objective response rate (ORR) in patients with on-treatment-ctDNA guided therapy continuation or escalation by addition of platinum-doublet chemotherapy to therapy continuation with Nivolumab-Ipilimumab regardless of on treatment-ctDNA results.

Time frame
Duration of time between the date of first treatment and the date of objectively documented progression per irRECIST or the date of initiation of palliative local therapy or the date of subsequent anti-cancer therapy, whichever occurs first, up to 36 mo
4

Duration of Response

To compare duration of response (DOR) in patients with on-treatment-ctDNA guided therapy continuation or escalation by addition of platinum-doublet chemotherapy to therapy continuation with Nivolumab-Ipilimumab regardless of on-treatment-ctDNA results.

Time frame
Duration of time between the date of first confirmed response to the date of the first documented tumor progression (per irRECIST), or death due to any cause, whichever occurs first, up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hackensack Meridian Health

Lead sponsor

MedSIR

Collaborator

Source ClinicalTrials.gov
Apply now