Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Aug 1, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the combination of two medications, afatinib and prednisone, to see how well they work for people with advanced squamous non-small cell lung cancer (NSCLC) who have already received treatment. The aim is to find out if this combination can help improve outcomes for patients with this type of lung cancer. Currently, the trial is recruiting participants aged 18 and older who have been treated for their cancer before, but not with certain types of medications like EGFR inhibitors or anti-TNF antibodies.

To be eligible for the trial, participants need to have a confirmed diagnosis of advanced squamous NSCLC and must have measurable disease. They should be in good overall health, with specific requirements for blood counts and organ function. Participants will need to provide consent to join and will be monitored throughout the study. It's also important for anyone interested to know that they cannot be pregnant or nursing, as the medications could harm a developing baby or nursing infant. Overall, this trial offers a potential new treatment option for those facing advanced lung cancer.

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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.