Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC

  • End date
    Sep 1, 2024
  • participants needed
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 9 July 2022


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


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.

Condition Advanced Squamous Non Small Cell Lung Cancer
Treatment Afatinib + Prednisone
Clinical Study IdentifierNCT04497584
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on9 July 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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