Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma

Phase 2 Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma

The primary purpose of this study is to find out if Afatinib can help treat participants with advanced cSCC.

Study Overview

• Status: Recruiting
• Conditions: Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Afatinib 40 MG

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ashley Paneto-Matos; Phone Number: 813-745-3922; Email: Ashley.Paneto-Matos@moffitt.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Contact: Zeynep Eroglu, MD; Phone Number: 813-745-7488; Email: Zeynep.Eroglu@moffitt.org
      • Principal Investigator: Zeynep Eroglu, MD
      • Contact: Maureen Canelo; Phone Number: 813-745-4277; Email: Maureen.Canelo@moffitt.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Afatinib Intervention; Participants will receive afatinib 40 mg once a day. Each cycle is 4 weeks. They will have CT imaging (and/or digital photography) done at baseline and every 8 weeks while on treatment. Participants will have a baseline and on-treatment (at 4 weeks) tumor biopsy, and a biopsy at disease progression if feasible. Patients may remain on treatment as long as they are deriving clinical benefit, until disease progression or intolerable toxicity.

Drug: Afatinib 40 MG; Participants will receive 40 mg Afatinib, once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate	Overall response rate (ORR) as defined by proportion of patients who have achieved a complete or partial response per RECIST 1.1 criteria	Up to 1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	Progression free survival, defined as the time from first dose to the earlier date of assessment of progression or death by any cause in the absence of progression	Up to 5 Years
Overall survival	Overall survival, as measured from the date of first dose to the date of death by any cause	Up to 5 Years
Treatment-related adverse events	Treatment-related adverse events per NCI CTCAE v5 criteria	Up to 40 days after end of treatment

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Zeynep Eroglu, MD, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Clinical Trial Search

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Skin Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Skin Diseases; Carcinoma; Neoplasms, Squamous Cell; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Skin Neoplasms; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amides; Quinazolines; Afatinib
• Other Study ID Numbers: MCC-20731

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes