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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Hackensack Meridian Health
Study ID
NCT05715229
Phase
PHASE2
Status
Recruiting
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Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Immunotherapy
  • Ipilimumab — DRUG
    Immunotherapy
  • Carboplatin — DRUG
    Chemotherapy
  • Paclitaxel — DRUG
    Chemotherapy
  • Pemetrexed — DRUG
    Chemotherapy

Study Details

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.

Key Dates

Start date
Sep 29, 2023
Status verified
Feb 2026
Primary completion
Apr 28, 2027
Completion
Apr 28, 2027

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    Arm A - Intervention arm (Immunotherapy and Chemotherapy) Nivolumab 360 mg/kg every 3 weeks Ipilimumab 1 mg/kg every 6 weeks Platinum- doublet Chemotherapy (Histology-based) 4 cycles depending on the investigator's discretion. Carboplatin dosed at AUC 5, and either Paclitaxel 175 mg/m2 for squamous or Pemetrexed 500 mg/m2 for non-squamous
  • Other: Arm B
    Arm B - control arm (Immunotherapy only) Nivolumab 360 mg/kg every 3 weeks Ipilimumab 1 mg/kg every 6 weeks

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Time from randomization to objective disease progression, or death from any cause, whichever first, up to 36 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer Center, Georgetown UniversityWashington D.C.District of Columbia20007-
John Theurer Cancer Center, Hackensack Meridian HealthHackensackNew Jersey07410
551-996-2000
Jersey Shore University Medical CenterNeptune CityNew Jersey07753
Walter Elliot
[email protected]
Suzanne Kosky
[email protected]
551-996-3986

Find similar trials in Washington D.C., DC

By research site
Lombardi Comprehensive Cancer Center, Georgetown University· Washington D.C., DCJohn Theurer Cancer Center, Hackensack Meridian Health· Hackensack, NJJersey Shore University Medical Center· Neptune City, NJ

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