Clinical Trials

Numerous clinical trials evaluate therapeutic interventions targeting epidermal growth factor receptor pathways and associated side effects, spanning early phase 1 through phase 4 studies. Ranging in status from recruiting and completed to terminated and not yet recruiting, these evaluations focus on non-small cell lung cancer, metastatic colorectal cancer, cutaneous squamous cell carcinoma, and EGFR inhibitor-induced dermatologic complications. Trial sponsors include major academic medical centers such as Sun Yat-sen University and Washington University, research cooperatives, and pharmaceutical companies including Novartis and Astellas Pharma.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07715734 NOT_YET_RECRUITING
Kidney Transplant Recipient; Cutaneous Squamous Cell Carcinoma (CSCC); Advanced Cutaneous Squamous Cell Carcinoma; Kidney Transplant
Washington University School of Medicine
 2026-09-30 PHASE2
NCT07790510 RECRUITING
Metastatic Colorectal Cancer (CRC)
Haisco Pharmaceutical Group Co., Ltd.
 2026-08-12 PHASE1; PHASE2
NCT07621497 NOT_YET_RECRUITING
Metastatic Colorectal Cancer (CRC)
Sun Yat-sen University
 2026-06-01 PHASE2
NCT07217028 RECRUITING
SCC - Squamous Cell Carcinoma; Radiotracer; Head and Neck Squamous Cell Carcinoma; Metastatic Head and Neck Squamous Cell Carcinoma
Vanderbilt-Ingram Cancer Center
 2026-04-24 PHASE1
NCT07686445 NOT_YET_RECRUITING
Solid Tumor (Phase I); RAS Mutation; CEACAM5
Adlai Nortye Biopharma Co., Ltd.
 2026-09-23 PHASE1
NCT07326566 RECRUITING
Glioblastoma (GBM); Newly Diagnosed Glioblastoma; GBM; Glioblastoma Multiforme (GBM); Glioma; Central Nervous System Diseases; Brain Cancer
Black Diamond Therapeutics, Inc.
 2026-05-05 PHASE2
NCT07094893 NOT_YET_RECRUITING
Colorectal Cancer
Gruppo Oncologico del Nord-Ovest
 2026-09-15 PHASE4
NCT03586453 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung
Dana-Farber Cancer Institute
 2018-08-13 PHASE2
NCT06046495 RECRUITING
Non-Small Cell Lung Cancer
Avistone Biotechnology Co., Ltd.
 2024-07-08 PHASE1
NCT06302621 RECRUITING
Advanced Solid Tumor; Unresectable Solid Tumor; Metastatic Solid Tumor; Cholangiocarcinoma
Massachusetts General Hospital
 2024-04-17 PHASE1
NCT07768189 NOT_YET_RECRUITING
Oropharyngeal Carcinoma (OPC)
Corbus Pharmaceuticals Inc.
 2026-09-20 PHASE3
NCT06020066 ACTIVE_NOT_RECRUITING
Brain Metastases; Non-small Cell Lung Cancer
Fudan University
 2023-08-10 PHASE2
NCT07089641 RECRUITING
Glioblastoma; Glioblastoma, IDH-Wildtype; Gliosarcoma; Recurrent Glioblastoma, IDH-Wildtype; Recurrent Gliosarcoma; Resectable Glioblastoma
Jonsson Comprehensive Cancer Center
 2025-07-28 PHASE1
NCT03392246 ACTIVE_NOT_RECRUITING
Non-small Cell Lung Cancer
Dana-Farber Cancer Institute
 2018-01-31 PHASE2
NCT06109558 RECRUITING
Non Small Cell Lung Cancer; RET Gene Mutation; MET Amplification; EGF-R Positive Non-Small Cell Lung Cancer
Hunan Province Tumor Hospital
 2023-12-31 PHASE1; PHASE2
NCT03122717 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
Dana-Farber Cancer Institute
 2017-05-09 PHASE1; PHASE2
NCT06818058 RECRUITING
EGFR Inhibitor-associated Rash
Tarian Pharma
 2025-01-20 PHASE2
NCT06418724 NOT_YET_RECRUITING
Locally Advanced Cutaneous Squamous Cell Carcinoma
Melanoma and Skin Cancer Trials Limited
 2026-07-30 PHASE2
NCT05256290 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer; Advanced Non-Small Cell Squamous Lung Cancer; Metastatic Lung Non-Small Cell Carcinoma; Metastatic Lung Cancer; NSCLC; Advanced Lung Carcinoma; Epidermal Growth Factor Receptor C797S; Epidermal Growth Factor Receptor G719X; EGF-R Positive Non-Small Cell Lung Cancer; EGFR-TKI Resistant Mutation
Black Diamond Therapeutics, Inc.
 2022-03-31 PHASE1; PHASE2
NCT05002270 COMPLETED
Advanced Solid Tumor; NSCLC; CRC
Jacobio Pharmaceuticals Co., Ltd.
 2021-09-03 PHASE1; PHASE2
NCT04824079 COMPLETED
Non-Small Cell Lung Cancer With EGFR Mutation; Brain Metastases
Medolution Ltd.
 2020-10-21 PHASE2
NCT03471364 COMPLETED
Malignant Neoplasm
Mayo Clinic
 2018-09-25 EARLY_PHASE1
NCT00254384 COMPLETED
Recurrent Lung Non-Small Cell Carcinoma; Stage IA Lung Non-Small Cell Carcinoma AJCC v7; Stage IB Lung Non-Small Cell Carcinoma AJCC v7; Stage IIA Lung Non-Small Cell Carcinoma AJCC v7; Stage IIB Lung Non-Small Cell Carcinoma AJCC v7; Stage IIIA Lung Non-Small Cell Cancer AJCC v7; Stage IIIB Lung Non-Small Cell Cancer AJCC v7
M.D. Anderson Cancer Center
 2005-10-05 PHASE1
NCT03428958 COMPLETED
Colorectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma; Colorectal Tumors; Neoplasms, Colorectal
NuCana plc
 2018-10-05 PHASE1; PHASE2
NCT04759664 UNKNOWN
EGFRI Induced Acneiform Lesions
Lutris Pharma Ltd.
 2021-04-12 PHASE2
NCT05209256 UNKNOWN
NSCLC
The First Affiliated Hospital of Henan University of Science and Technology
 2022-03-01 PHASE2; PHASE3
NCT06118047 Recruiting
Metastatic Colorectal Cancer|Cetuximab|Skin Toxicity
Sun Yat-sen University
 2023-08-01 Phase 2
NCT03983993 ACTIVE_NOT_RECRUITING
Advanced Microsatellite Stable Colorectal Carcinoma; Metastatic Microsatellite Stable Colorectal Carcinoma; Microsatellite Stable; RAS Wild Type; Stage IV Colorectal Cancer AJCC v8; MSI-H Colorectal Cancer
Emory University
 2019-10-15 PHASE2
NCT05120362 UNKNOWN
Acneiform Eruptions
Shanghai East Hospital
 2021-11-03
NCT06001671 COMPLETED
NSCLC
Hunan Province Tumor Hospital
 2020-10-27 PHASE1
NCT05165082 COMPLETED
Paronychia; Epidermal Growth Factor Receptor Inhibitor
Taipei Medical University WanFang Hospital
 2021-12-21
NCT05153408 TERMINATED
Lung Neoplasm; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; EGFR C797S; EGFR C797A; EGFR L858R; EGFR Exon 19 Deletion; EGFR Gene Mutation; EGF-R Positive Non-Small Cell Lung Cancer; EGFR Mutation Resulting in Tyrosine Kinase Inhibitor Resistance; EGFR Activating Mutation; Thoracic Neoplasms; Antineoplastic Agents; Protein Kinase Inhibitors; EGFR C797G; EGFR C797X; Non Small Cell Lung Cancer
Blueprint Medicines Corporation
 2022-01-13 PHASE1
NCT03904823 UNKNOWN
EGFR-mutant Non-Small Cell Lung Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2019-04-25 PHASE2
NCT04239846 COMPLETED
EGFR Inhibitor-Induced Skin Rash
TWi Biotechnology, Inc.
 2019-10-02 PHASE2
NCT03666325 UNKNOWN
Skin Neoplasm
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
 2018-10-01 PHASE2
NCT03876106 COMPLETED
EGFR Inhibitor Induced Acneiform Lesions
Lutris Pharma Ltd.
 2019-08-21 PHASE1
NCT01586624 COMPLETED
Cancer; Non Small Cell Lung Cancer
Cancer Research UK
 2012-01-10 PHASE1
NCT02448251 TERMINATED
Non Small Cell Lung Cancer
ACEA Therapeutics, Inc.
 2015-05 PHASE1
NCT02025114 COMPLETED
Non-small Cell Lung Cancer (NSCLC)
National Taiwan University Hospital
 2014-09 PHASE1; PHASE2
NCT02284139 COMPLETED
Non-small Cell Lung Cancer; Pancreatic Cancer; Colorectal Cancer
Dong-A University Hospital
 2015-04 PHASE2; PHASE3
NCT03051880 Unknown status
Drug-Related Side Effects and Adverse Reactions|Epidermal Growth Factor
The Catholic University of Korea
 2016-11 Not Applicable
NCT03047863 Unknown status
Drug-Related Side Effects and Adverse Reactions|Epidermal Growth Factor
The Catholic University of Korea
 2016-11 Not Applicable
NCT01610336 COMPLETED
Non-small Cell Lung Cancer
Novartis Pharmaceuticals
 2012-04-05 PHASE2
NCT01892527 COMPLETED
Colorectal Cancer Metastatic; C-met Overexpression
Armando Santoro, MD
 2013-03 PHASE2
NCT02588261 Terminated
Non-small Cell Lung Cancer (NSCLC)
Astellas Pharma Global Development Inc.|Astellas Pharma Inc
 2016-02-11 Phase 3
NCT01449461 COMPLETED
Lymphoma, Large-Cell, Anaplastic; Carcinoma, Non-Small-Cell Lung
Ariad Pharmaceuticals
 2011-09-20 PHASE1; PHASE2
NCT01647711 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2012-07 PHASE1
NCT01522612 TERMINATED
Colorectal Cancer Metastatic
European Organisation for Research and Treatment of Cancer - EORTC
 2013-04 PHASE2
NCT00496652 COMPLETED
Cancer of the Head and Neck
Danish Head and Neck Cancer Group
 2007-11 PHASE3
NCT00977548 COMPLETED
Myelodysplastic Syndrome
H. Lee Moffitt Cancer Center and Research Institute
 2009-09 PHASE2
NCT01205685 TERMINATED
Hormone-sensitive Metastatic Breast Cancer
Vanderbilt-Ingram Cancer Center
 2010-05 PHASE2
NCT00656786 COMPLETED
EGFR Inhibitor-associated Rash
Spectrum Pharmaceuticals, Inc
 2008-04-03 PHASE1
NCT01013506 WITHDRAWN
Breast Cancer
Vanderbilt-Ingram Cancer Center
 2009-08 PHASE2
NCT00169221 TERMINATED
Head and Neck Cancer
Groupe Oncologie Radiotherapie Tete et Cou
 2005-09 PHASE2
NCT00910676 COMPLETED
Metastatic Colorectal Cancer; Non-Small-Cell Lung Carcinoma
Centre Oscar Lambret
 2007-10 PHASE2
NCT00124280 COMPLETED
Non-small-cell Lung Carcinoma
Novartis Pharmaceuticals
 2005-07 PHASE2
NCT00098501 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
 2004-10 PHASE1
NCT00362986 COMPLETED
Dermatologic Complications; Unspecified Adult Solid Tumor, Protocol Specific
Alliance for Clinical Trials in Oncology
 2006-10 PHASE3
NCT00343187 TERMINATED
Rash; Non-small-Cell Lung Cancer
Allergan
 2006-06 PHASE2
NCT00091247 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Alliance for Clinical Trials in Oncology
 2004-12
NCT00072072 COMPLETED
Lung Cancer
Jonsson Comprehensive Cancer Center
 2003-08 PHASE1
NCT00049556 COMPLETED
Cervical Cancer; Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
National Cancer Institute (NCI)
 2002-10 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-20)

Check the EGFR Inhibitor product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

This cell-permeable, 4,6-disubstituted pyrimidine compound selectively binds to and inhibits epidermal growth factor receptor kinase activity while simultaneously triggering direct microtubule depolymerization, thereby blocking downstream oncogenic signal transduction cascades. By disrupting mitotic spindle organization and inhibiting tumor cell proliferation, this dual mechanism provides critical therapeutic efficacy against EGFR-driven malignancies including non-small cell lung cancer and metastatic colorectal cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.