NCT05013450

Dupilumab_Metastatic NSCLC

A Phase 1b/2 Trial of Dupilumab Given in Conjunction With PD-1 or PD-L1 Blockade and Anakinra in the Treatment of Relapsed/Refractory Metastatic NSCLC

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Thomas Marron · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-09-10
• Primary completion: 2025-09-10
• Completion: 2025-12-09
• First posted: 2021-08-19
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study