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Dupilumab_Metastatic NSCLC

NCT05013450 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-12-17

No results posted yet for this study

Summary

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.

Conditions

  • Metastatic Non-small Cell Lung Cancer

Interventions

DRUG

Dupilumab

three q3w cycles

DRUG

PD-1/PD-L1 blockade

SOC immunotherapy with PD-1/PD-L1 blockade

DRUG

Anakinra

100 mg daily injection for Three q3w cycles

Sponsors & Collaborators

  • Thomas Marron

    lead OTHER

Principal Investigators

  • Thomas Marron, MD, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-10
Primary Completion
2025-09-10
Completion
2025-12-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05013450 on ClinicalTrials.gov