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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tumor shrinkage

Secondary outcome measures

Duration of response in weeks

Overall survival in months

Progression-free survival in weeks

+1 more

Other outcome measures

Exploratory biomarker analysis

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimIndustry Sponsor

2,507 Previous Clinical Trials

11,340,524 Total Patients Enrolled

National Comprehensive Cancer NetworkNETWORK

115 Previous Clinical Trials

7,585 Total Patients Enrolled

Yale UniversityLead Sponsor

1,848 Previous Clinical Trials

2,737,768 Total Patients Enrolled

Media Library

Afatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02979977 — Phase 2

Squamous Cell Carcinoma Research Study Groups: All subjects

Squamous Cell Carcinoma Clinical Trial 2023: Afatinib Highlights & Side Effects. Trial Name: NCT02979977 — Phase 2

Afatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02979977 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How hazardous is the utilization of cetuximab for individuals?

"Cetuximab's safety has been backed by some data, earning it a score of 2 on our team at Power's scale. As this is Phase 2 trial, there is yet to be any evidence supporting its efficacy in treating certain medical conditions."

Answered by AI

What is the aggregate quantity of participants for this research endeavor?

"Affirmative. Records hosted on clinicaltrials.gov confirm that this medical trial, which was initially advertised on March 24th 2017, is actively seeking participants. 50 volunteers need to be sourced from one centre for enrollment in the study."

Answered by AI

What pathologies commonly benefit from cetuximab treatment?

"Cetuximab is commonly utilised to treat metastatic squamous cell carcinoma of the head and neck, but it also has proven efficacy with malignant neoplasms, squamous cell carcinomas, and diagnoses determined by an approved FDA test."

Answered by AI

Are there any past experiments regarding cetuximab that have yielded noteworthy results?

"As of today, there are 151 ongoing studies for cetuximab. Of those, 32 have entered Phase 3. While the majority of these trials are hosted in Dresden and Arizona, various other sites across the world have joined to study this drug - totalling 7511 locations."

Answered by AI

Is this trial accessible to participants at present?

"Indeed, the entry on clinicaltrials.gov states that this study is actively seeking patients. Initially posted on March 24th 2017 and recently updated on February 10th 2022, it needs to enroll 50 participants from a single medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dual Inhibition of EGFR With Afatinib and Cetuximab in the Treatment of Advanced Squamous Cell Cancers of the Head and Neck

2017. "Dual Inhibition of EGFR With Afatinib and Cetuximab in the Treatment of Advanced Squamous Cell Cancers of the Head and Neck". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02979977.

All > Head And Neck Cancer