Phase 2 Study of Afatinib and Prednisone for Advanced Squamous Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

• Must provide written informed consent before participating.
• Have advanced squamous NSCLC that has been treated with up to three previous therapies.
• Have not been treated with EGFR inhibitors, IMIDs, or anti-TNF antibodies before.
• Have not used systemic glucocorticoids within three weeks before starting the study (topical and inhaled glucocorticoids are allowed).
• Be 18 years or older.
• Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have adequate organ and bone marrow function, including:
  • Neutrophil count of at least 1,000/μL
  • Platelet count of at least 50,000/μL
  • Normal bilirubin levels
  • AST and ALT levels no more than 2.5 times the upper limit of normal
  • Creatinine clearance of at least 45 ml/min
• Use effective contraception during the study and for three months after the last dose.
• Provide adequate tissue samples for study purposes.
• Have measurable disease according to standard criteria.

Exclusion Criteria

• Have received chemotherapy, radiotherapy, or other cancer treatments within two weeks before starting the study. Must have recovered from any side effects of previous treatments to a mild level, except for hair loss and stable conditions requiring ongoing management.
• Are receiving other investigational treatments for the cancer being studied.
• Have symptomatic brain metastases or brain metastases requiring increasing doses of corticosteroids.
• Have a history of allergic reactions to afatinib or prednisone.
• Have uncontrolled illnesses, such as poorly managed diabetes, heart failure, unstable chest pain, irregular heartbeats, or psychiatric conditions that could interfere with the study.
• Must not be pregnant or breastfeeding due to potential risks to the baby.