Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma

NCT05070403 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MCC-20731
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Squamous Cell Carcinoma

Keywords

Skin Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression free survival

  Up to 5 Years

• Overall survival

  Up to 5 Years

• Treatment-related adverse events

  Up to 40 days after end of treatment

Study Arms (1)

Afatinib Intervention

EXPERIMENTAL

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

Interventions

Afatinib 40 MG DRUG

Participants will receive 40 mg Afatinib, once daily.

Afatinib Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Related Links

• Moffitt Clinical Trial Search

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Skin Neoplasms

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Zeynep Eroglu, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: October 1, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)