Study on Afatinib for Treating Advanced Skin Cancer (Cutaneous Squamous Cell Carcinoma)

Inclusion Criteria

• Must be 18 years or older.
• Must be in relatively good health, with an ECOG performance status of 0, 1, or 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Must have adequate blood cell counts and organ function, including:
  • Neutrophil count of at least 1.0 × 10^9/L.
  • Hemoglobin level of at least 8 g/dL.
  • Platelet count of at least 75 × 10^9/L.
  • Liver enzymes (AST and ALT) no more than 5 times the upper limit of normal.
  • Kidney function with creatinine clearance greater than 15 mL/min.
• Must have a confirmed diagnosis of invasive cutaneous squamous cell carcinoma that cannot be treated with surgery or radiation.
• Must have at least one measurable tumor, either by standard imaging criteria or visible and measurable by photography.
• Must have previously received immunotherapy with an anti-PD-1/PD-L1 antibody, if eligible.
• Immunosuppressed individuals, including those with autoimmune diseases or organ transplants, can participate.
• Must be at least two weeks from any prior cancer treatment, major surgery, or radiation before starting the study treatment.
• Must be able to have a tumor biopsy before and during treatment.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception. Men must also agree to use contraception.
• Participants with treated brain metastases are allowed if they have been stable after surgery or radiation.

Exclusion Criteria

• Severe liver impairment (Child Pugh C) in participants with known liver cirrhosis.
• Untreated or unstable brain metastases or cancer spread to the brain lining that require steroids.
• Mixed cancer types, unless the main type is invasive cutaneous squamous cell carcinoma.
• Other cancers that could interfere with the study's safety or effectiveness.
• HIV-positive participants are eligible if they are on effective treatment with an undetectable viral load.
• Participants with hepatitis C must have been treated and cured, or have an undetectable viral load if currently on treatment.
• Pregnant or breastfeeding women are not eligible.