Dupilumab_Metastatic NSCLC

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

Sponsor
Thomas Marron
Study ID
NCT05013450
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

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

Start date
Sep 10, 2021
Status verified
Dec 2025
Primary completion
Sep 10, 2025
Completion
Dec 9, 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-

Find similar trials in New York, NY

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

Related Studies