Combining afatinib and prednisone for advanced lung cancer treatment
An Investigator-sponsored Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous Non-small Cell Lung Cancer
This study is testing if combining afatinib and prednisone can help people with advanced lung cancer who have already been treated feel better and respond to the treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | afatinib, Chemotherapy, prednisone |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04497584 on ClinicalTrials.gov |
What this trial studies
This phase 2 trial aims to evaluate the safety and effectiveness of afatinib, an EGFR inhibitor, combined with prednisone, a TNF inhibitor, in patients with advanced squamous non-small cell lung cancer (NSCLC) who have previously undergone treatment. The study will assess the recommended dose, maximum tolerated dose, and identify potential biomarkers that could predict treatment response. Participants will receive this combination therapy to determine its efficacy in managing their condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with previously treated advanced squamous NSCLC and an ECOG performance status of 0 or 1.
Not a fit: Patients who have previously received EGFR inhibitors or systemic glucocorticoids within three weeks prior to the study may not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced squamous NSCLC who have limited treatment choices.
How similar studies have performed: Other studies have explored combinations of targeted therapies and immunosuppressants, showing promise, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Sheena Bhalla, MD — UT Southwestern Medical Center
- Study coordinator: Sheena Bhalla, MD
- Email: sheena.bhalla@utsouthwestern.edu
- Phone: 214-648-4180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.