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

  • End date
    Jan 24, 2023
  • participants needed
  • sponsor
    Yale University
Updated on 24 March 2022


This is a single arm Phase II study for patients with recurrent or metastatic squamous cell carcinoma of the head and neck, who are previously treated with a platinum based regimen or with an immune checkpoint inhibitor. The primary objective is to evaluate the efficacy of the combination of cetuximab and afatinib.


This study will be a multicenter, single-arm, open-label Phase II trial. Patients with advanced squamous cell carcinoma of the head and neck, who are previously treated with a platinum based regimen or with immune checkpoint inhibitor therapy or both, will be eligible for participation on the study. After a baseline evaluation and biopsy (where feasible), they will be treated with weekly/bi-weekly intravenous cetuximab and daily oral afatinib. Biopsy will be repeated where feasible after 4 weeks (window of +1 week) on therapy and again at disease progression or end of treatment.

Treatment will continue until disease progression or development of Grade 3 or higher drug related toxicities that fail to resolve to Grade 2 despite appropriate supportive care.

Condition Squamous Cell Cancers of the Head and Neck
Treatment Cetuximab, Afatinib
Clinical Study IdentifierNCT02979977
SponsorYale University
Last Modified on24 March 2022


Yes No Not Sure

Inclusion Criteria

Histologically confirmed squamous cell carcinoma of the head and neck that is metastatic, recurrent or locally advanced and not treatable with curative intent
Previous treatment with a platinum-based regimen or immune checkpoint inhibitor or both.2-week washout period prior to treatment start will be required
Patients who have experienced progression of disease within 6 months following completion of a platinum-based chemoradiation in the definitive or adjuvant setting will be permitted
Prior cetuximab permitted if it was given as part of multi-modality therapy for initial treatment of locally advanced disease
Measurable disease based on RECIST v 1.1. Baseline measurements and evaluations must be obtained within 4 weeks of enrollment. Disease in previously irradiated sites is considered measurable if there has been unequivocal disease progression or biopsy-proven residual carcinoma following radiation therapy
ECOG performance status ≤2
Adequate organ function, defined as all of the following
Hemoglobin ≥ 8 g/dl
Absolute neutrophil count (ANC) ≥1000 / mm3
Platelet count ≥75,000 / mm3
Estimated creatinine clearance > 45ml / min
Total Bilirubin ≤ 1.5 times upper limit of (institutional/central) normal (Patients with Gilbert's syndrome total bilirubin must be ≤4 times institutional upper limit of normal)
Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≤ three times the upper limit of (institutional/central) normal (ULN) (if related to liver metastases ≤ five times ULN)
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

Exclusion Criteria

Prior erlotinib, gefitinib or lapatinib therapy or prior exposure to any investigational EGFR or panErbB reversible or irreversible inhibitor or any prior panitumumab or investigational EGFR-directed monoclonal antibody
Radiotherapy within 2 weeks prior to enrollment. Palliative radiation to target organs may be allowed up to 2 weeks prior to enrollment, as long as there are other target lesions that can be monitored for response to study treatment
Known hypersensitivity to afatinib or its excipients
Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use highly effective methods of birth control prior to study entry, for the duration of study participation and for at least 4 weeks after treatment has ended
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
Concomitant malignancies at other sites that are being actively treated with systemic therapy
Requiring treatment with any of the prohibited concomitant medications that cannot be stopped for the duration of trial participation
Clinically significant interstitial lung disease
Known history of untreated viral hepatitis or HIV
Patients with parenchymal brain metastases are not eligible, unless they have completed local therapy
Leptomeningeal carcinomatosis
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