Cetuximab Overview

Introduction of Cetuximab

Cetuximab (C225, IMC-C225) is an epidermal growth factor receptor (EGFR) binding Fab fragment. Cetuximab is chimerized from the Fv (variable; antigen-binding) regions of the myeloma cell line 225, a mouse monoclonal antibody (mAb) that blocks the ligand-binding site of the EGFR, and a human immunoglobulin G (IgG) constant region (framework) gene segment. Cetuximab is developed by ImClone, now a fully owned subsidiary of Eli Lilly and Company. It is distributed under the trade name Erbitux in the U.S. and Canada by the drug company Bristol-Myers Squibb and outside those countries by the drug company Merck KGaA. In Japan, Merck KGaA, Bristol-Myers Squibb and Eli Lilly have a co-distribution. Erbitux had worldwide sales since it’s approval, making it a lucrative target for biosimilars developers. However biosimilars of Erbitux are not expected until 2018.

Cetuximab was approved by the Food and Drug Administration (FDA) in March 2006 for use in combination with radiation therapy for treating squamous cell carcinoma of the head and neck (SCCHN) or as a single agent in patients who have had prior platinum-based therapy. In July 2009, the FDA approved cetuximab (Erbitux) for treatment of colon cancer with wild-type KRAS, since it had little or no effect in colorectal tumors harboring a KRAS mutation (this also applied to the EGFR antibody panitumumab). This was the first genetic test to guide treatment of cancer. In July 2012, the FDA approved a real time PCR companion diagnostic test for KRAS, the Therascreen® KRAS test. The KRAS gene encodes a small G protein on the EGFR pathway. Cetuximab and other EGFR inhibitors only work on tumors in which KRAS is not mutated.

Mechanism of Action of Cetuximab

Cetuximab is the first of its kind to be approved for treating metastatic colorectal cancer. Cetuximab binds specifically to the EGFR (also known as erbB-1, HER1), which is expressed on both tumor and normal cells and competitively inhibits the binding of its natural ligands such as epidermal growth factor as well as other factors including transforming growth factor-α (TGF-α). Since the expression of EGFR is elevated on many types of solid tumor cells including those from the colon and rectum, Cetuximab’s inhibitory effect is more pronounced on tumor cells than on normal cells. Binding of Cetuximab to EGFR blocks the phosphorylation and activation of receptor-associated tyrosine kinase (normally following the binding of the natural ligands) and consequently leads to the inhibition of tumor cell growth, induction of apoptosis and a reduction in the production of matrix metalloproteinases and vascular endothelial growth factor. EGFR is a member of a subfamily of type I receptor tyrosine kinases that include HER1 (EGFR), HER2, HER3, and HER4. EGFR is actively expressed in some types of tissues including skin and hair follicles, which is the possible basis by which the use of Cetuximab results in the adverse reaction of a skin rash in a large percentage of patients (88%) after receiving the drug. In summary, Cetuximab inhibits receptor tyrosine kinase activity, endocytoses EGFR, inhibits cell cycle regulation, induces apoptosis, inhibits angiogenesis, inhibits invasion/metastasis, and inhibits cell repair or recovery after chemotherapy or radiation.

Mechanism of action of CetuximabFig.1 Mechanism of action of Cetuximab

Table 1. Clinical Projects of Cetuximab*

NCT ID Status Conditions Lead Sponsor Update Time
NCT03126708 Recruiting Esophageal Cancer, Squamous Cell, Cetuximab Effect, Chemotherapy Effect Peking University April 24, 2017
NCT03524820 Recruiting Cancer of Colon Hadassah Medical Organization May 15, 2018
NCT02296203 Active, not recruiting Metastatic Colorectal Cancer Gruppo Oncologico del Nord-Ovest November 20, 2014
NCT01801904 Active, not recruiting Metastatic Colorectal Cancer National Cancer Institute, Naples March 1, 2013
NCT01832467 Active, not recruiting Metastatic Colorectal Cancer Chinese University of Hong Kong April 16, 2013
NCT02953782 Recruiting Colorectal Neoplasms, Solid Tumors Forty Seven, Inc. November 3, 2016
NCT02117466 Recruiting Metastatic Colorectal Cancer VU University Medical Center April 21, 2014
NCT02499120 Active, not recruiting Squamous Cell Carcinoma of the Head and Neck (SCCHN) Pfizer July 15, 2015
NCT01719380 Active, not recruiting Colorectal Cancer Array BioPharma November 1, 2012
NCT03667482 Recruiting Head and Neck Squamous Cell Cancer, Recurrent Head and Neck Squamous Cell Cancer, Metastatic Head and Neck Squamous Cell Cancer Memorial Sloan Kettering Cancer Center September 12, 2018
NCT03134846 Recruiting Head and Neck Squamous Cell Carcinoma, Margin Assessment University Medical Center Groningen May 1, 2017
NCT03446157 Recruiting Cancer of the Colon, Colon Cancer, Colon Neoplasms, Colonic Cancer, Neoplasms, Colonic UNC Lineberger Comprehensive Cancer Center February 26, 2018
NCT02717923 Recruiting Colorectal Neoplasms Huazhong University of Science and Technology March 24, 2016
NCT02282371 Active, not recruiting Head and Neck Squamous Cell Cancer Memorial Sloan Kettering Cancer Center November 4, 2014
NCT03391934 Recruiting Metastatic Colorectal Cancer Cinnagen January 5, 2018
NCT03524326 Recruiting Head and Neck Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Head and Neck Cancer, Head and Neck Carcinoma Memorial Sloan Kettering Cancer Center May 14, 2018
NCT01693159 Recruiting Pain National Center for Tumor Diseases, Heidelberg September 26, 2012
NCT03401957 Recruiting Colorectal Cancer, Drug Resistance, Mass Spectrometry, RAS-RAF Pathway Deregulation National Health Research Institutes, Taiwan January 17, 2018
NCT01871311 Recruiting Colorectal Cancer, Head and Neck Cancer Georgetown University June 6, 2013
NCT01251536 Active, not recruiting Colorectal Cancer Universitaire Ziekenhuizen Leuven December 2, 2010
NCT01592721 Active, not recruiting Squamous Cell Carcinoma, Head and Neck Cancer Anand B. Karnad May 7, 2012
NCT03391843 Active, not recruiting Rectal Cancer Stage III RenJi Hospital January 5, 2018
NCT02095054 Active, not recruiting Advanced Cancers M.D. Anderson Cancer Center March 24, 2014
NCT01025089 Active, not recruiting Thymoma, Thymic Carcinoma, Clinical Masaoka Stage II to IVA Memorial Sloan Kettering Cancer Center December 3, 2009
NCT02054442 Recruiting Squamous Cell Carcinoma of the Head and Neck Radboud University February 4, 2014
NCT03717155 Recruiting Squamous Non-Small Cell Lung Cancer Merck KGaA, Darmstadt, Germany October 24, 2018
NCT01787500 Active, not recruiting Advanced Cancers M.D. Anderson Cancer Center February 8, 2013
NCT03254927 Recruiting Advanced Head and Neck Squamous Cell Carcinoma Celldex Therapeutics August 21, 2017
NCT03498378 Recruiting Head and Neck Squamous Cell Carcinoma Kathryn Gold April 13, 2018
NCT03290937 Recruiting Malignant Neoplasms of Digestive Organs, Colorectal Cancer M.D. Anderson Cancer Center September 25, 2017
NCT03493048 Recruiting Colo-rectal Cancer, Liver Metastases Sun Yat-sen University April 10, 2018
NCT03082534 Recruiting HNSCC, Lip SCC, Oral Cavity Cancer, Oropharynx Cancer, Larynx Cancer, Hypopharynx Cancer, Nasopharynx Cancer, Sinonasal Carcinoma, Cutaneous Squamous Cell Carcinoma, Head and Neck Neoplasms, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma Assuntina G. Sacco March 17, 2017
NCT01640444 Active, not recruiting Colorectal Cancer Metastatic Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) July 13, 2012
NCT03769311 Not yet recruiting Head and Neck Cancer, Squamous Cell Carcinoma University of Wisconsin, Madison December 7, 2018
NCT03325738 Recruiting Squamous Cell Cutaneous Carcinoma of the Skin Centre Antoine Lacassagne October 30, 2017
NCT01552434 Recruiting Advanced Malignant Neoplasm, Castleman Disease, Digestive System Carcinoma, Erdheim-Chester Disease, Lip and Oral Cavity Carcinoma, Lymphangioleiomyomatosis, Malignant Endocrine Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Male Reproductive System Neoplasm, Malignant Neoplasm, Malignant Respiratory Tract Neoplasm, Malignant Thoracic Neoplasm, Malignant Urinary System Neoplasm, Mesothelial Neoplasm, Metastatic Malignant Neoplasm, Metastatic Urothelial Carcinoma, Neurofibromatosis Type 2, Recurrent Adult Soft Tissue Sarcoma, Recurrent Breast Carcinoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Digestive System Carcinoma, Recurrent Female Reproductive System Carcinoma, Recurrent Male Reproductive System Carcinoma, Recurrent Malignant Neoplasm, Recurrent Pharyngeal Carcinoma, Recurrent Thyroid Gland Carcinoma, Refractory Malignant Neoplasm, Soft Tissue Neoplasm, Stage III Breast Cancer AJCC v7, Stage III Pharyngeal Cancer, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7, Stage IV Pharyngeal Cancer, Stage IVA Pharyngeal Cancer, Stage IVB Pharyngeal Cancer, Stage IVC Pharyngeal Cancer, Thyroid Gland Neoplasm M.D. Anderson Cancer Center March 13, 2012
NCT02124707 Active, not recruiting Head and Neck Cancer, Squamous Cell Carcinoma of the Head and Neck UNC Lineberger Comprehensive Cancer Center April 28, 2014
NCT01621217 Active, not recruiting Locally Advanced Cancer in the Anal Region Lund University Hospital June 18, 2012
NCT02978313 Not yet recruiting Colorectal Cancer Ruijin Hospital November 30, 2016
NCT01969877 Active, not recruiting Locally Advanced Head and Neck Cancer Lund University Hospital October 25, 2013
NCT01802645 Recruiting Colorectal Cancer Technische Universität Dresden March 1, 2013
NCT03457896 Recruiting Metastatic Colorectal Cancer NSABP Foundation Inc March 8, 2018
NCT02063529 Recruiting Metastatic Colorectal Cancer Sun Yat-sen University February 14, 2014
NCT02128906 Recruiting Squamous Cell Carcinoma Dwight Heron May 1, 2014
NCT02324608 Recruiting Recurrent Skin Cancer, Squamous Cell Carcinoma of the Skin Rutgers, The State University of New Jersey December 24, 2014
NCT03370276 Recruiting Squamous Cell Carcinoma of the Oropharynx, Squamous Cell Carcinoma of the Larynx, Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Hypopharynx, Squamous Cell Carcinoma of the Paranasal Sinus, Head and Neck Squamous Cell Carcinoma, Squamous Cell Cancer, Head and Neck Carcinoma H. Lee Moffitt Cancer Center and Research Institute December 12, 2017
NCT02713373 Recruiting Recurrent Colorectal Carcinoma, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer Roswell Park Cancer Institute March 18, 2016
NCT03051906 Not yet recruiting Head and Neck Neoplasms Azienda Ospedaliero-Universitaria Careggi February 14, 2017
NCT01884259 Active, not recruiting Squamous Cell Carcinoma of the Hypopharynx Stage III, Squamous Cell Carcinoma of the Hypopharynx Stage IV, Squamous Cell Carcinoma of the Larynx Stage III, Squamous Cell Carcinoma of the Larynx Stage IV, Squamous Cell Carcinoma of the Oropharynx Stage III, Squamous Cell Carcinoma of the Oropharynx Stage IV, Squamous Cell Carcinoma of the Oral Cavity Stage III, Squamous Cell Carcinoma of the Oral Cavity Stage IV Arbeitsgemeinschaft medikamentoese Tumortherapie June 24, 2013
NCT02101034 Recruiting Carcinoma, Squamous Cell of Head and Neck Washington University School of Medicine April 1, 2014
NCT02942706 Not yet recruiting Colorectal Cancer Ruijin Hospital October 24, 2016
NCT03727724 Active, not recruiting Carcinoma, Non-Small-Cell Lung The Netherlands Cancer Institute November 1, 2018
NCT02404935 Recruiting Metastatic Colorectal Cancer UNICANCER April 1, 2015
NCT01012609 Active, not recruiting Brain Cancer Memorial Sloan Kettering Cancer Center November 13, 2009
NCT02716311 Recruiting Non Small Cell Lung Cancer Intergroupe Francophone de Cancerologie Thoracique March 23, 2016
NCT03485638 Recruiting Tumor Disease Including Colorectal Cancer, Head & Neck Squamous Cell Carcinoma Yonsei University April 2, 2018
NCT03774680 Recruiting Colon Cancer, Colo-rectal Cancer Ahmed A. H. Abdellatif December 13, 2018
NCT03174405 Active, not recruiting Metastatic Colorectal Cancer AIO-Studien-gGmbH June 2, 2017
NCT03024489 Recruiting Head and Neck Cancer, Locally Advanced, Unresectable Mahidol University January 18, 2017
NCT02999087 Recruiting HNSCC Groupe Oncologie Radiotherapie Tete et Cou December 21, 2016
NCT02277197 Active, not recruiting Carcinoma, Squamous Cell of Head and Neck, Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma, Head And Neck James J Lee October 28, 2014
NCT01716416 Active, not recruiting Squamous Cell Carcinoma of the Head and Neck Washington University School of Medicine October 29, 2012
NCT02429089 Active, not recruiting Squamous Cell Carcinoma of the Head and Neck Cliniques universitaires Saint-Luc- Université Catholique de Louvain April 29, 2015
NCT01154920 Active, not recruiting Head and Neck Squamous Cell Carcinoma M.D. Anderson Cancer Center July 1, 2010
NCT02268695 Active, not recruiting Head and Neck Squamous Cell Carcinoma Groupe Oncologie Radiotherapie Tete et Cou October 20, 2014
NCT03693170 Not yet recruiting BRAF V600E-mutant Metastatic Colorectal Cancer Pierre Fabre Medicament October 2, 2018
NCT02938273 Recruiting Carcinoma, Squamous Cell of Head and Neck The Netherlands Cancer Institute October 19, 2016
NCT03087071 Recruiting Colorectal Cancer M.D. Anderson Cancer Center March 22, 2017
NCT01696955 Active, not recruiting Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Carcinoma National Cancer Institute (NCI) October 2, 2012
NCT03422536 Recruiting Head and Neck Basaloid Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Unknown Primary Origin, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IV Oropharyngeal Squamous Cell Carcinoma, Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVA Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVA Oropharyngeal Squamous Cell Carcinoma, Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVB Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVB Oropharyngeal Squamous Cell Carcinoma, Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVC Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVC Oropharyngeal Squamous Cell Carcinoma, Head and Neck Cancer, Oropharyngeal Cancer, HNSCC, Stage IV Lip and Oral Cavity Squamous Cell Carcinoma University of Arizona February 5, 2018
NCT01254617 Active, not recruiting Recurrent Colon Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Laryngeal Verrucous Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary, Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Recurrent Oral Cavity Verrucous Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Recurrent Rectal Carcinoma, Recurrent Salivary Gland Carcinoma, Salivary Gland Squamous Cell Carcinoma, Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary, Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage IVA Colon Cancer AJCC v7, Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Laryngeal Verrucous Carcinoma AJCC v7, Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVA Major Salivary Gland Cancer AJCC v7, Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, Stage IVA Oral Cavity Cancer AJCC v6 and v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Rectal Cancer AJCC v7, Stage IVB Colon Cancer AJCC v7, Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Laryngeal Verrucous Carcinoma AJCC v7, Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVB Major Salivary Gland Cancer AJCC v7, Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, Stage IVB Oral Cavity Cancer AJCC v6 and v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Rectal Cancer AJCC v7, Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVC Laryngeal Verrucous Carcinoma AJCC v7, Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVC Major Salivary Gland Cancer AJCC v7, Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, Stage IVC Oral Cavity Cancer AJCC v6 and v7, Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7, Tongue Carcinoma, Untreated Metastatic Squamous Cell Carcinoma to Neck With Occult Primary National Cancer Institute (NCI) December 6, 2010
NCT01855451 Active, not recruiting HPV Positive Oropharyngeal Squamous Cell Carcinoma Trans-Tasman Radiation Oncology Group (TROG) May 16, 2013
NCT02861898 Recruiting Glioblastoma, Brain Cancer, Brain Neoplasm, Brain Tumor, Brain Neoplasm, Malignant, EGFR Gene Overexpression, GBM Northwell Health August 10, 2016
NCT03691714 Recruiting Recurrent Head and Neck Cancer, Head and Neck Cancer, Head and Neck Neoplasms, Metastatic Cancer Trisha Wise-Draper October 2, 2018
NCT02515734 Not yet recruiting Colorectal Cancer Japan Clinical Cancer Research Organization August 5, 2015
NCT03286738 Recruiting Metastatic Colorectal Cancer Joong Bae Ahn September 18, 2017
NCT01874171 Active, not recruiting Oropharyngeal Squamous Cell Carcinoma University of Warwick June 10, 2013
NCT03031444 Recruiting Colorectal Cancer Stage IV, Metastasis Beijing Cancer Hospital January 25, 2017
NCT02624128 Recruiting Squamous Cell Carcinoma of the Head and Neck National Cancer Institute, Naples December 8, 2015
NCT00316888 Active, not recruiting Anal Cancer ECOG-ACRIN Cancer Research Group April 21, 2006
NCT02643550 Recruiting Head and Neck Neoplasms Innate Pharma December 31, 2015
NCT03109158 Recruiting Carcinoma, Squamous Cell of Head and Neck NanoCarrier Co., Ltd. April 12, 2017
NCT02934529 Recruiting Metastatic Colorectal Cancer Ludwig-Maximilians - University of Munich October 17, 2016
NCT02979977 Recruiting Squamous Cell Cancers of the Head and Neck Yale University December 2, 2016
NCT02484833 Recruiting Antineoplastic Agents Carlo Barone June 30, 2015
NCT02164916 Active, not recruiting Colorectal Cancer Southwest Oncology Group June 17, 2014
NCT02633176 Recruiting Nasopharyngeal Carcinoma Sun Yat-sen University December 17, 2015
NCT01302834 Active, not recruiting Head and Neck Cancer, Precancerous Condition Radiation Therapy Oncology Group February 24, 2011
NCT02270814 Recruiting Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Cancer of the Head and Neck Washington University School of Medicine October 21, 2014
NCT01935921 Active, not recruiting Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7 National Cancer Institute (NCI) September 5, 2013
NCT01468896 Active, not recruiting Head and Neck Squamous Cell Carcinoma National Cancer Institute (NCI) November 10, 2011
NCT02707588 Active, not recruiting Squamous Cell Carcinoma of the Head and Neck Groupe Oncologie Radiotherapie Tete et Cou March 14, 2016
NCT01979211 Active, not recruiting Head and Neck Cancer University of Cincinnati November 8, 2013
NCT00999700 Active, not recruiting Squamous Cell Carcinoma of the Head and Neck Gruppo Oncologico del Nord-Ovest October 22, 2009
NCT03608046 Not yet recruiting Colorectal Neoplasms, Malignant Cliniques universitaires Saint-Luc- Université Catholique de Louvain July 31, 2018
NCT02052960 Active, not recruiting Carcinoma, Squamous Cell of Head and Neck Glycotope GmbH February 3, 2014
NCT00997009 Active, not recruiting Cervical Cancer National Cancer Institute, Naples October 16, 2009
NCT01816984 Active, not recruiting Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Salivary Gland Squamous Cell Carcinoma, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IVA Salivary Gland Cancer, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Salivary Gland Cancer, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Stage IVC Salivary Gland Cancer, Stage IVC Squamous Cell Carcinoma of the Larynx, Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVC Verrucous Carcinoma of the Larynx, Stage IVC Verrucous Carcinoma of the Oral Cavity, Tongue Cancer University of Chicago March 22, 2013
NCT01437449 Active, not recruiting Head and Neck Cancer Stanford University September 20, 2011
NCT01243372 Active, not recruiting Colorectal Cancer Alliance for Clinical Trials in Oncology November 18, 2010
NCT03365882 Recruiting Colon Adenocarcinoma, ERBB2 Gene Amplification, Rectal Adenocarcinoma, Recurrent Colon Carcinoma, Recurrent Rectal Carcinoma, Stage III Colon Cancer AJCC v7, Stage III Rectal Cancer AJCC v7, Stage IIIA Colon Cancer AJCC v7, Stage IIIA Rectal Cancer AJCC v7, Stage IIIB Colon Cancer AJCC v7, Stage IIIB Rectal Cancer AJCC v7, Stage IIIC Colon Cancer AJCC v7, Stage IIIC Rectal Cancer AJCC v7, Stage IV Colon Cancer AJCC v7, Stage IV Rectal Cancer AJCC v7, Stage IVA Colon Cancer AJCC v7, Stage IVA Rectal Cancer AJCC v7, Stage IVB Colon Cancer AJCC v7, Stage IVB Rectal Cancer AJCC v7 Southwest Oncology Group December 7, 2017
NCT02800486 Recruiting Glioblastoma, Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Glioma, Brain Neoplasm, Brain Cancer, Brain Tumor, Brain Tumor, Recurrent, Brain Neoplasm, Malignant Northwell Health June 15, 2016
NCT02438722 Active, not recruiting Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer Southwest Oncology Group May 8, 2015
NCT02822482 Recruiting Carcinoma, Squamous Cell of Head and Neck UNICANCER July 4, 2016
NCT02438995 Recruiting Carcinoma, Squamous Cell, Carcinoma, Squamous Cell of Head and Neck Northwell Health May 8, 2015
NCT02369458 Recruiting Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma, Head and Neck Washington University School of Medicine February 24, 2015
NCT01864772 Active, not recruiting Metastatic or Recurrent Head and Neck Squamous Cell Cancer Groupe Oncologie Radiotherapie Tete et Cou May 30, 2013
NCT01860430 Active, not recruiting Cancer of Head and Neck Robert Ferris May 22, 2013
NCT02255097 Active, not recruiting Head and Neck Squamous Cell Carcinoma Merck Sharp & Dohme Corp. October 2, 2014
NCT02383966 Active, not recruiting Carcinoma, Squamous Cell of Head and Neck Merck KGaA, Darmstadt, Germany March 10, 2015
NCT00956007 Active, not recruiting Head and Neck Cancer Radiation Therapy Oncology Group August 11, 2009
NCT01810913 Active, not recruiting Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Verrucous Carcinoma of the Larynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Tongue Cancer Radiation Therapy Oncology Group March 14, 2013
NCT01884623 Active, not recruiting Head Neck Cancer Squamous Cell Recurrent Gustave Roussy, Cancer Campus, Grand Paris June 24, 2013
NCT00265850 Active, not recruiting Colorectal Cancer Alliance for Clinical Trials in Oncology December 15, 2005
NCT01104922 Active, not recruiting Squamous Cell Carcinoma of the Head and Neck Dwight Heron April 16, 2010
NCT00904345 Active, not recruiting Head and Neck Cancer University of Michigan Cancer Center May 19, 2009
NCT02627274 Recruiting Solid Tumor, Breast Cancer, Cancer of Head and Neck Hoffmann-La Roche December 10, 2015
NCT03356223 Recruiting Head and Neck Cancer, Advanced Cancer, Metastatic Cancer Centre Leon Berard November 29, 2017
NCT02057107 Recruiting Recurrent, Head and Neck Cancer University of Pittsburgh February 6, 2014
NCT01950689 Recruiting Head and Neck Squamous Cell Carcinoma The Christie NHS Foundation Trust September 25, 2013
NCT00655876 Active, not recruiting Esophageal Cancer Radiation Therapy Oncology Group April 10, 2008
NCT03688230 Not yet recruiting Metastatic Colorectal Cancer SFJ Pharmaceuticals X, LTD. September 28, 2018
NCT02928224 Recruiting BRAF V600E-mutant Metastatic Colorectal Cancer Array BioPharma October 10, 2016
NCT00736944 Active, not recruiting Squamous Cell Carcinoma of the Head and Neck Washington University School of Medicine August 18, 2008
NCT01079780 Active, not recruiting Colorectal Cancer Pam Cogliano March 3, 2010
NCT02292758 Active, not recruiting olorectal Adenocarcinoma, RAS Wild Type, Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7 Academic and Community Cancer Research United November 17, 2014
NCT00183898 Active, not recruiting Gastric Cancer, Esophageal Cancer University of Southern California September 16, 2005
NCT01442649 Active, not recruiting Colorectal Cancer UNICANCER September 28, 2011
NCT00265941 Active, not recruiting Head and Neck Cancer Radiation Therapy Oncology Group December 15, 2005
NCT00533949 Active, not recruiting Lung Cancer, Radiation Toxicity Radiation Therapy Oncology Group September 24, 2007
NCT03494322 Recruiting Head and Neck Cancer, Squamous Cell Carcinoma University College, London April 11, 2018
NCT00946712 Active, not recruiting Recurrent Large Cell Lung Carcinoma, Recurrent Lung Adenocarcinoma, Recurrent Squamous Cell Lung Carcinoma, Stage IV Large Cell Lung Carcinoma, Stage IV Lung Adenocarcinoma, Stage IV Squamous Cell Lung Carcinoma Southwest Oncology Group July 27, 2009
NCT03405272 Not yet recruiting Metastatic Colorectal Cancer Sinocelltech Ltd. January 23, 2018
NCT03652233 Not yet recruiting Recurrent Squamous Cell Carcinoma of the Head or Neck, Platinum- and Cetuximab-Refractory Squamous Cell Carcinoma of the Head or Neck, Metastatic Squamous Cell Carcinoma of the Head or Neck, Squamous Cell Carcinoma Vanderbilt-Ingram Cancer Center August 29, 2018
NCT01233843 Active, not recruiting Squamous Cell Head and Neck Carcinoma Groupe Oncologie Radiotherapie Tete et Cou November 3, 2010
NCT01884740 Recruiting Glioblastoma Multiforme, Fibrillary Astrocytoma of Brain, Glioma of Brainstem, Anaplastic Astrocytoma, Pilomyxoid Astrocytoma, Mixed Oligodendroglioma-Astrocytoma, Brain Stem Glioma, Diffuse Intrinsic Pontine Glioma Weill Medical College of Cornell University June 24, 2013
NCT00248287 Active, not recruiting Metastatic Breast Cancer US Oncology Research November 3, 2005
NCT01440270 Active, not recruiting Locally Advanced Malignant Neoplasm, Oral Cancer, Oropharyngeal Carcinoma Shanghai Jiao Tong University School of Medicine September 26, 2011
NCT00609284 Active, not recruiting HNSCC Groupe Oncologie Radiotherapie Tete et Cou February 7, 2008
NCT02845856 Recruiting Recurrent Non-small Cell Lung Cancer Fuda Cancer Hospital, Guangzhou July 27, 2016
NCT02507154 Recruiting Nasopharyngeal Cancer, Head and Neck Squamous Cell Carcinoma National University Hospital, Singapore July 23, 2015
NCT03727763 Recruiting Colorectal Cancer Shanghai Changzheng Hospital November 1, 2018
NCT03356158 Recruiting Metastatic Colorectal Cancer Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. November 29, 2017
NCT02636088 Active, not recruiting Esophageal Neoplasm Gabriella Alexandersson von Döbeln December 21, 2015
NCT03646461 Not yet recruiting Head and Neck Cancer, Squamous Cell Carcinoma of the Head and Neck University of California, San Diego August 24, 2018
NCT01412229 Active, not recruiting Head and Neck Cancer UNC Lineberger Comprehensive Cancer Center August 9, 2011
NCT02236936 Recruiting Squamous Cell Carcinoma of the Hypopharynx Stage III, Squamous Cell Carcinoma of the Hypopharynx Stage IV, Laryngeal Squamous Cell Carcinoma Stage III, Laryngeal Squamous Cell Carcinoma Stage IV, Oropharyngeal Squamous Cell Carcinoma Stage III, Oropharyngeal Squamous Cell Carcinoma Stage IV, Squamous Cell Carcinoma of the Oral Cavity Stage III, Squamous Cell Carcinoma of the Oral Cavity Stage IV, Locally Advanced Malignant Neoplasm Arbeitsgemeinschaft medikamentoese Tumortherapie September 11, 2014
NCT01393821 Active, not recruiting Dermatologic Complications, Malignant Neoplasm, Pain Mayo Clinic July 13, 2011
NCT00543504 Active, not recruiting Advanced Cancer M.D. Anderson Cancer Center October 15, 2007
NCT03532737 Recruiting Locally Advanced Head and Neck Cancer Kuwait Cancer Control Center May 22, 2018
NCT01874860 Recruiting Colorectal Cancer, Head and Neck Cancer University of Louisville June 11, 2013
NCT01867697 Active, not recruiting Metastatic Colorectal Cancer Per Pfeiffer June 4, 2013
NCT02826837 Not yet recruiting Advanced Colorectal Cancer Taiwan Leader Biotech Corp. July 11, 2016
NCT01059188 Active, not recruiting Lung Cancer Swiss Group for Clinical Cancer Research January 29, 2010
NCT01726309 Recruiting Colorectal Cancer, Non-Small Cell Lung Cancer Cancer Trials Ireland November 14, 2012
NCT02741570 Recruiting Head and Neck Cancer Bristol-Myers Squibb April 18, 2016
NCT01588431 Active, not recruiting Carcinoma, Squamous Cell of Head and Neck Anand B. Karnad May 1, 2012
NCT01737450 Recruiting Head and Neck Neoplasms, Neoplasm Metastasis, Recurrent Disease, Progressive Disease Centre Leon Berard November 29, 2012
NCT01675999 Recruiting Colon Cancer, Locally Advanced Malignant Neoplasm Assistance Publique - Hôpitaux de Paris August 30, 2012
NCT01097642 Active, not recruiting Breast Cancer Jenny C. Chang, MD April 1, 2010
NCT03603379 Not yet recruiting Glioblastoma University Hospital, Basel, Switzerland July 27, 2018
NCT03426371 Recruiting Metastatic Colorectal Cancer Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. February 8, 2018
NCT01420874 Active, not recruiting Colorectal Cancer, Cancer of Pancreas, Pancreatic Neoplasm, Malignant Neoplasm of Large Intestine, Malignant Tumor of Colon, Colon Carcinoma, Cancer of Colon, Pancreatic Cancer Barbara Ann Karmanos Cancer Institute August 22, 2011
NCT03692520 Not yet recruiting Advanced Solid Tumors Sinocelltech Ltd. October 2, 2018
NCT03692689 Recruiting Triple Negative Breast Neoplasms Sinocelltech Ltd. October 2, 2018
NCT03146338 Recruiting Metastatic Colorectal Cancer, Metastatic Head and Neck Cancer Weprom May 9, 2017
NCT03744208 Not yet recruiting Head and Neck Squamous Cell Carcinoma Shi Yuankai November 16, 2018
NCT03713372 Not yet recruiting Head and Neck Cancer Sinocelltech Ltd. October 19, 2018
NCT03717038 Not yet recruiting Metastatic Colorectal Cancer, Colorectal Cancer Metastatic, Carcinoma Symphogen A/S October 23, 2018
NCT03549338 Active, not recruiting Metastatic Colorectal Cancer, Colorectal Cancer Metastatic, Carcinoma Symphogen A/S June 8, 2018
NCT02948985 Not yet recruiting Colorectal Cancer Metastatic Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine October 31, 2016
NCT03666325 Not yet recruiting Skin Neoplasm Fondazione IRCCS Istituto Nazionale dei Tumori, Milano September 11, 2018

Table 2. Approved Drugs of Cetuximab**

INN (trade name) Therapeutic area Dose Strength Route Company Marketing start Market
Erbitux Head and Neck Cancer; Colorectal Cancer; K-Ras Wild-Type, EGFR-Expressing, Metastatic Colorectal Cancer Solution 2 mg / mL Intravenous infusion ImClone February 12, 2004 Cetuximab Overview
Erbitux Head and Neck Neoplasms, Colorectal Neoplasms Solution 5 mg / mL Intravenous infusion Merck KGaA June 29, 2004 Cetuximab Overview
Erbitux EGFR-Expressing, RAS Wild-Type Metastatic Colorectal Cancer; Squamous Cell Carcinoma of the Head and Neck Solution 2 mg / mL Intravenous infusion ImClone LLC October 28, 2008 Cetuximab Overview
Erbitux EGFR-Expressing, RAS Wild-Type Metastatic Colorectal Cancer,  Squamous Cell Cancer of The Head and Neck Solution 5 mg / mL Intravenous infusion Merck Serono Australia Pty Ltd September 25, 2007 Cetuximab Overview
Erbitux EGFR-Expressing, RAS Wild-Type Metastatic Colorectal Cancer,  Squamous Cell Cancer of The Head and Neck Solution 5 mg / mL Intravenous infusion Merck Serono July 16, 2008 Cetuximab Overview

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Reference
* The table was excerpted from the following website
https://clinicaltrials.gov/ct2/results?cond=&term=Cetuximab

** Information presented in the table were collected from the following website:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125084
https://www.ema.europa.eu/en/medicines/human/EPAR/erbitux
http://search.tga.gov.au/s/search.html?collection=tga-artg&profile=record&meta_i=132393
https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=75672
http://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/4291415A1

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