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Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497584
Recruitment Status : Not yet recruiting
First Posted : August 4, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
David E Gerber, University of Texas Southwestern Medical Center

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

Condition or disease Intervention/treatment Phase
Advanced Squamous Non Small Cell Lung Cancer Drug: Afatinib + Prednisone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Afatinib 40 mg PO daily Prednisone 40 mg PO daily (starting 7 days after afatinib)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigator-sponsored Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous Non-small Cell Lung Cancer
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497584


Contacts
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Contact: David E Gerber, MD 214-648-7097 David.Gerber@UTSouthwestern.edu
Contact: Jessica Saltarski, BS 214-648-7097 Jessica.Saltarski@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Contact: Jessica Saltarski, BS    214-648-7097    jessica.saltarski@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: David Gerber, MD UT Southwestern Medical Center
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Responsible Party: David E Gerber, Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04497584    
Other Study ID Numbers: STU-2020-0509
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Prednisone
Afatinib
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action