Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC

NCT04497584 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STU-2020-1363
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Squamous Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival of combined afatinib and prednisone in previously treated NSCLC

  Measure progression-free survival rate.

  From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months

Secondary Outcomes (3)

• Response rate of combined afatinib and prednisone in previously treated NSCLC

  From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months

• Overall survival of combined afatinib and prednisone in previously treated NSCLC

  From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months

• Safety of combined afatinib and prednisone in previously treated NSCLC

  From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months

Study Arms (1)

Afatinib + Prednisone

EXPERIMENTAL

Afatinib 40 mg PO daily Prednisone 40 mg PO daily starting 7 days after Afatinib

Drug: Afatinib + Prednisone

Interventions

Afatinib + Prednisone DRUG

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.

Afatinib + Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
• Previously treated (up to three prior lines of therapy), histologically proven advanced squamous NSCLC.
• No prior treatment with EGFR inhibitors, IMIDs (eg, thalidomide, lenalidomide), or anti-TNF antibodies.
• No treatment with systemic glucocorticoids within 3 weeks of initiation of study therapy (topical and inhaled glucocorticoids are permitted).
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ and marrow function as defined below:
• absolute neutrophil count ≥ 1,000/μL
• platelets ≥ 50,000/μl
• total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
• CrCl ≥ 45 ml/min
• For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment.
• Adequate archival tissue (5-10 slides) for correlative studies.
• Subject must have measurable disease per RECIST 1.1

You may not qualify if:

• Chemotherapy, radiotherapy, or other cancer therapy within two weeks prior to starting study treatment. Subjects must have recovered from prior treatment-related to toxicities to grade 1 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism from prior immune checkpoint inhibitor treatment).
• Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
• Symptomatic brain metastases or brain metastases requiring escalating doses of corticosteroids
• History of hypersensitivity or allergic reactions attributed to afatinib or prednisone.
• Uncontrolled intercurrent illness including but not limited to poorly controlled diabetes (which may worsen in setting of chronic prednisone therapy), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Afatinib; Prednisone

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sheena Bhalla, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Afatinib 40 mg PO daily Prednisone 40 mg PO daily (starting 7 days after afatinib)

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: August 4, 2020
• Study Start: August 4, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)