Clinical Trials /

Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC

NCT04497584

Description:

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

Related Conditions:
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC
  • Official Title: An Investigator-sponsored Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous Non-small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: STU-2020-0509
  • NCT ID: NCT04497584

Conditions

  • Advanced Squamous Non Small Cell Lung Cancer

Interventions

DrugSynonymsArms
Afatinib + PrednisoneAfatinib + Prednisone

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Afatinib + PrednisoneExperimentalAfatinib 40 mg PO daily Prednisone 40 mg PO daily starting 7 days after Afatinib
  • Afatinib + Prednisone

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Measure progression-free survival rate.

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:Measure response rate by evaluation of target lesions by measuring disease.
Measure: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
Safety Issue:
Description:Measure Overall Survival, as the time from the date of initiation of study treatment until death of any cause.
Measure: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
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University of Texas Southwestern Medical Center

Last Updated

August 1, 2020