Dupilumab_Metastatic NSCLC

Part of paid clinical trials in New York, New York.

Sponsor
Thomas Marron
Study ID
NCT05013450
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Non-small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Dupilumab — DRUG
    three q3w cycles
  • PD-1/PD-L1 blockade — DRUG
    SOC immunotherapy with PD-1/PD-L1 blockade
  • Anakinra — DRUG
    100 mg daily injection for Three q3w cycles

Study Details

This is a multi cohort, sequential enrollment clinical trial to determine the safety and tolerability of Dupilumab and Anakinra with PD-(L)1 blockade for patients with relapsed/refractory metastatic NSCLC. For Phase 2, to determine the effect of adding IL-4Ra and IL-1R blockade to PD-(L)1 blocking agents in patients with relapsed/refractory NSCLC, who have progressed on prior PD-(L)1 agents.

Key Dates

First listed
Aug 19, 2021
Start date
Sep 10, 2021
Status verified
Jul 2026
Primary completion
Sep 11, 2025
Completion
Sep 18, 2025

Study Design

Enrollment
33 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab + anti-PD-1/PD-L1 (SOC)
    Patients will continue SOC immunotherapy with PD-1/PD-L1 blockade following progression of disease, and three q3w cycles of dupilumab will be administered
  • Experimental: Anakinra + Dupilumab + anti-PD-1/PD-L1 (SOC)
    Patients will continue SOC immunotherapy with PD-1/PD-L1 blockade following progression of disease, and three q3w cycles of dupilumab and anakinra will be administered

Primary Outcome Measure

Dose Limiting Toxicity (DLTs) [ Time Frame: 9 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tisch Cancer Institute, Mount Sinai HospitalNew YorkNew York10003-

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By research site
Tisch Cancer Institute, Mount Sinai Hospital· New York, NY

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