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Tyrosine Kinase Inhibitor

Afatinib for Advanced Skin Cancer

Phase 2

Recruiting

Led By Zeynep Eroglu, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Must not have

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

In participants with known liver cirrhosis, those with severe (Child Pugh C) hepatic impairment will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if Afatinib can help treat people with advanced cSCC.

Who is the study for?

Adults with advanced cutaneous squamous cell carcinoma (cSCC) not suitable for surgery/radiation, who've had prior immunotherapy if eligible. Must have good organ function and performance status, a measurable lesion, and be at least 2 weeks post any major treatment or surgery. Those with treated brain metastases can join; however, those with severe liver issues, mixed cancer types, untreated HIV/HCV or pregnancy are excluded.

What is being tested?

The trial is testing the effectiveness of Afatinib 40 MG in treating advanced cSCC. Participants will receive this medication to see if it improves their condition compared to previous treatments they may have received.

What are the potential side effects?

While specific side effects for this trial aren't listed here, common ones associated with Afatinib include diarrhea, skin rashes and reactions, nail inflammation, mouth sores and decreased appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least one cancer lesion that can be measured or seen and photographed.

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I have a type of skin cancer that can't be treated with surgery or radiation.

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I can take care of myself but might not be able to do heavy physical work.

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I have a weakened immune system, including autoimmune diseases or organ transplants.

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I am 18 years old or older.

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My blood counts and organ functions are within the required ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HIV with undetectable viral load or cured hepatitis C.

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I do not have severe liver cirrhosis.

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I have brain metastases or leptomeningeal carcinomatosis that are untreated, unstable, or require steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate

Secondary study objectives

Overall survival

Progression free survival

Treatment-related adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Afatinib InterventionExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Afatinib 40 MG

2022

Completed Phase 2

~10

0 / 9Eligibility criteria met