Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC

October 17, 2023 updated by: Sheena Bhalla, University of Texas Southwestern Medical Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Afatinib + Prednisone

Afatinib 40 mg PO daily

Prednisone 40 mg PO daily starting 7 days after Afatinib
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival of combined afatinib and prednisone in previously treated NSCLC
Time Frame: From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate of combined afatinib and prednisone in previously treated NSCLC
Time Frame: From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months
Measure response rate by evaluation of target lesions by measuring disease.
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
Time Frame: From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months
Measure Overall Survival, as the time from the date of initiation of study treatment until death of any cause.
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
Time Frame: From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months
Measure risk to study participants by completing blood test and assessing according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0.
From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Sheena Bhalla, MD, UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

August 1, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2020-1363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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