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Tyrosine Kinase Inhibitor

Cetuximab + Afatinib for Head and Neck Cancer

Phase 2

Recruiting

Led By Aarti Bhatia, MD, MPH

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Adequate organ function including Hemoglobin ≥ 8 g/dl, ANC ≥1000 / mm3, Platelet count ≥75,000 / mm3, Estimated creatinine clearance > 45ml / min, Total Bilirubin ≤ 1.5 times upper limit of normal, AST or ALT ≤ three times the upper limit of normal, Ability to understand and the willingness to sign a written informed consent that is consistent with ICH-GCP guidelines, Negative urine or serum pregnancy test for women of childbearing potential

Histologically confirmed squamous cell carcinoma of the head and neck that is metastatic, recurrent or locally advanced and not treatable with curative intent

Must not have

Clinically significant interstitial lung disease

Known history of untreated viral hepatitis or HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of cetuximab and afatinib for patients with squamous cell carcinoma of the head and neck who have previously been treated with a platinum-based regimen or an immune checkpoint inhibitor.

Who is the study for?

This trial is for adults with advanced squamous cell carcinoma of the head and neck that has returned or spread after platinum-based chemotherapy or immune checkpoint inhibitor treatment. Participants must have measurable disease, be in a stable condition (ECOG ≤2), and have proper organ function. Pregnant women, those with certain allergies, untreated viral hepatitis or HIV, recent radiotherapy recipients, and individuals on prohibited medications are excluded.

What is being tested?

The study tests combining two drugs—cetuximab and afatinib—to treat recurrent or metastatic head and neck cancer. It's a Phase II trial to see how effective this drug duo is when other treatments like chemo haven't worked.

What are the potential side effects?

Possible side effects include skin reactions (acne-like rash), diarrhea, mouth sores, low magnesium levels leading to muscle weakness or cramps, infusion-related reactions such as fever or chills during cetuximab administration, and liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

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

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My cancer in the head or neck area is advanced and cannot be cured 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've had platinum-based or immune therapy with a 2-week break before starting this treatment.

Exclusion Criteria

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

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I have a serious lung condition affecting the tissue and space around the air sacs.

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I have untreated viral hepatitis or HIV.

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I have previously been treated with specific lung cancer medications or experimental drugs targeting EGFR.

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I am currently receiving treatment for cancer at another site in my body.

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My cancer has spread to the lining of my brain and spinal cord.

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I am not on any medication that can't be stopped during the trial.

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I haven't had radiotherapy in the last 2 weeks, except for palliative care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Tumor shrinkage

Secondary study objectives

Overall survival in months

Progression-free survival in weeks

Other study objectives

Exploratory biomarker analysis

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: All subjectsExperimental Treatment2 Interventions

Advanced squamous cell carcinoma of the head and neck region, having previously been treated on a platinum based regimen or with an immune checkpoint inhibitor. Subjects will receive Afatinib dose 30 mg per day and weekly/bi-weekly intravenous cetuximab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cetuximab

2000

Completed Phase 3

~7290

afatinib

2016

Completed Phase 3

~2590