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Study of Afatinib for Advanced Skin Cancer

This study is testing a drug called Afatinib to see if it can help people with advanced cutaneous squamous cell carcinoma (a type of skin cancer). You might be able to join if you are at least 18 years old, have this type of cancer, and meet certain health requirements like good organ function. The study aims to measure how many participants respond to Afatinib treatment over a period of up to one year. We don't have information about the current recruitment status for this study.

Study design
This study plans to enroll 35 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Participants will receive 40 mg of Afatinib once daily. Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure your response to treatment for up to one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05070403

Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~35 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Afatinib 40 MG

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate
Measured over Up to 1 Year

Conditions

Squamous Cell Carcinoma

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Skin Squamous Cell Carcinoma

NCT05070403

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Moffitt Cancer Center

    Tampa, Floridano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Zeynep Eroglu, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Age ≥ 18 years at the time of informed consent
ECOG performance status ≤2
Adequate bone marrow, organ function and laboratory parameters:
ANC ≥ 1.0 × 109/L;
Hemoglobin ≥ 8 g/dL;
Platelets ≥ 75 × 109/L;
AST and ALT ≤5 × ULN
Calculated creatinine clearance \> 15mL/min by Cockroft-Gault formula
Histologic diagnosis of invasive cutaneous squamous cell carcinoma, that is deemed not appropriate for further surgical intervention and/or radiation therapy. Participants may have either locally advanced or metastatic disease.
At least 1 measurable lesion - either per RECIST 1.1 criteria, or for patients with externally visible cuSCC lesion(s) not measurable on imaging, at least one lesion ≥1 cm in longer diameter, amenable to digital photography with bi-dimensional measurements
Participants must have received prior immunotherapy with an anti-PD-1/PD-L1 antibody, if participant was deemed eligible (i.e., was not immunosuppressed or a transplant receipt, etc)
Immunosuppressed participant including those with concurrent autoimmune diseases and solid organ transplant recipients are eligible
Prior to first dose of study treatment, participant must be at least 2 weeks from any prior systemic therapy, major surgery or radiation
Able to undergo a pre-treatment and on-treatment tumor biopsy
Female participants of childbearing potential must have a negative serum or urine β-HCG test result. Female participants of childbearing potential and male participants must agree to use methods of contraception that are highly effective.
Participants with brain metastases are permitted assuming that the brain metastases have been adequately treated with prior surgery or radiation.

Exclusion

In participants with known liver cirrhosis, those with severe (Child Pugh C) hepatic impairment will be excluded.
Untreated, uncontrolled or symptomatic brain metastases or leptomeningeal carcinomatosis that are not stable or require corticosteroids,
Participants with mixed histologies (eg, sarcomatoid, adenosquamous) will generally not be eligible, unless the predominant histology is invasive cuSCC.
Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 90 days prior to randomization. Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load prior to randomization.
Pregnancy or breast feeding.

What this trial measures

  • Overall Response RateUp to 1 Year

    Overall response rate (ORR) as defined by proportion of patients who have achieved a complete or partial response per RECIST 1.1 criteria