Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC
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|ClinicalTrials.gov Identifier: NCT04497584|
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : June 30, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Advanced Squamous Non Small Cell Lung Cancer||Drug: Afatinib + Prednisone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|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)|
|Official Title:||An Investigator-sponsored Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous Non-small Cell Lung Cancer|
|Actual Study Start Date :||August 4, 2021|
|Estimated Primary Completion Date :||September 1, 2023|
|Estimated Study Completion Date :||September 1, 2024|
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.
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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
|Contact: Sheena Bhalla, MDfirstname.lastname@example.org|
|Contact: Jeffery Wilson, BS||214-648-7097||Jeffery.Wilson@UTSouthwestern.edu|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Jeffery Wilson, BS 214-648-7097 Jeffery.Wilson@UTSouthwestern.edu|
|Principal Investigator:||Sheena Bhalla, MD||UT Southwestern Medical Center|
|Responsible Party:||Sheena Bhalla, Assistant Professor of Medicine, University of Texas Southwestern Medical Center|
|Other Study ID Numbers:||
|First Posted:||August 4, 2020 Key Record Dates|
|Last Update Posted:||June 30, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action