Actively Recruiting
Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01
25
Participants Needed
1
Research Sites
334 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary purpose of this study is to find out if Afatinib can help treat participants with advanced cSCC.
CONDITIONS
Official Title
Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 218 years or older at the time of informed consent
- ECOG performance status of 2 or less
- Adequate bone marrow, organ function, and lab results: ANC 21 1.0 x 10^9/L; Hemoglobin 21 8 g/dL; Platelets 21 75 x 10^9/L; AST and ALT 21 5 times the upper limit of normal; creatinine clearance > 15 mL/min
- Histologic diagnosis of invasive cutaneous squamous cell carcinoma not suitable for further surgery or radiation, including locally advanced or metastatic disease
- At least one measurable lesion by RECIST 1.1 or visible lesion 21 1 cm suitable for photography
- Prior immunotherapy with anti-PD-1/PD-L1 antibody if eligible
- Immunosuppressed participants including those with autoimmune diseases or organ transplants are eligible
- At least 2 weeks since prior systemic therapy, major surgery, or radiation before study treatment
- Ability to undergo pre-treatment and on-treatment tumor biopsy
- Female participants of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception; male participants must agree to contraception
- Participants with treated brain metastases are allowed
You will not qualify if you...
- Severe hepatic impairment (Child Pugh C) in participants with known liver cirrhosis
- Untreated, uncontrolled, or symptomatic brain metastases or leptomeningeal carcinomatosis not stable or requiring corticosteroids
- Mixed tumor histologies unless invasive cutaneous squamous cell carcinoma is predominant
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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