NCT04497584

Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC

An Investigator-sponsored Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous Non-small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy of combined afatinib and prednisone in previously treated advanced squamous NSCLC

Detailed description

This two-stage phase 2 study will determine the safety, tolerability, recommended phase 2 dose/maximum tolerated dose, preliminary efficacy and predictive/pharmacodynamic biomarkers of combined EGFR inhibition (afatinib) and TNF inhibition (prednisone) in previously treated NSCLC.

Conditions

• Advanced Squamous Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Afatinib + Prednisone	Afatinib (40mg) will be taken by mouth daily starting on Cycle 1, Day -7. Prednisone (40mg) will be taken by mouth daily starting on Cycle 1, Day 1.

Timeline

• Start date: 2021-08-04
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2020-08-04
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study