Clinical Trials

Numerous clinical trials evaluate icotinib hydrochloride across various oncological indications, predominantly non-small cell lung cancer—including EGFR-mutated adenocarcinoma, squamous cell carcinoma, and bronchial neoplasms—alongside non-pulmonary conditions such as pancreatic cancer and neurofibromatosis type 2-associated vestibular schwannoma. Spanning Early Phase 1 through Phase 4, these studies encompass early safety evaluations to extensive post-marketing research. Sponsored by pharmaceutical entities like Betta Pharmaceuticals Co., Ltd., and academic institutions including Sun Yat-sen University and Fuda Cancer Hospital, trial statuses range from actively recruiting and completed to terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06955325 NOT_YET_RECRUITING
Non-Small Cell Lung Cancer
The First Affiliated Hospital of Guangzhou Medical University
 2025-05 PHASE3
NCT07458919 NOT_YET_RECRUITING
Lung Cancer
Fuzhou General Hospital
 2026-03-30 EARLY_PHASE1
NCT06041776 RECRUITING
Non-Small Cell Lung Cancer; EGFR Sensitive Mutation; Adjuvant Therapy
Betta Pharmaceuticals Co., Ltd.
 2023-03-28 PHASE3
NCT06517953 RECRUITING
Non-small Cell Lung Cancer Metastatic; EGFR G719X; EGFR L861Q; EGFR S768I
Sun Yat-sen University
 2024-07-17 PHASE2
NCT05007938 UNKNOWN
Non-Small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2021-08-12 PHASE2
NCT05514314 UNKNOWN
Non-Small Cell Lung Cancer
Wu Nan
 2022-09-01 PHASE2
NCT05132985 NOT_YET_RECRUITING
NSCLC; EGF-R Positive Non-Small Cell Lung Cancer
Liaoning Cancer Hospital & Institute
 2022-01-01 PHASE2
NCT05104788 RECRUITING
Non-Small Cell Lung Cancer
Peking University Cancer Hospital & Institute
 2021-10-25 PHASE2
NCT05263947 COMPLETED
Carcinoma, Non-Small-Cell Lung; Bevacizumab; Tyrosine Kinase Inhibitor; EGFR L858R
Tianjin Medical University Cancer Institute and Hospital
 2022-01-30 PHASE2
NCT02820116 UNKNOWN
Non-small Cell Lung Cancer(NSCLC)
Beijing Haidian Hospital
 2016-05 PHASE2
NCT04058704 UNKNOWN
Non Small Cell Lung Cancer; Brain Metastases
Betta Pharmaceuticals Co., Ltd.
 2018-07-20 PHASE3
NCT04206072 COMPLETED
Non-Small Cell Lung Cancer; EGFR Gene Mutation
Betta Pharmaceuticals Co., Ltd.
 2019-12-24 PHASE2; PHASE3
NCT02448797 UNKNOWN
Non-small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2015-06-08 PHASE3
NCT04797806 UNKNOWN
Non Small Cell Lung Cancer
Tianjin Medical University Cancer Institute and Hospital
 2021-03-12 PHASE3
NCT03749213 UNKNOWN
EGF-R Positive Non-Small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2018-12-01 PHASE2
NCT03349203 UNKNOWN
EGF-R Positive Non-Small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2018-10-01 PHASE2
NCT03396185 UNKNOWN
EGFR Gene Mutation; Non Small Cell Lung Cancer Stage IIIA; Non Small Cell Lung Cancer Stage IIIB
Betta Pharmaceuticals Co., Ltd.
 2018-05-09 PHASE2
NCT01996098 TERMINATED
Lung Cancer
Sun Yat-sen University
 2014-01-01 PHASE3
NCT02726568 UNKNOWN
Non-small Cell Lung Cancer; Brain Metastases
Betta Pharmaceuticals Co., Ltd.
 2016-03 PHASE2
NCT03983811 UNKNOWN
Carcinoma, Non-Small-Cell Lung
Nanfang Hospital, Southern Medical University
 2019-07-01
NCT03720873 UNKNOWN
EGFR Gene Mutation
Fujian Cancer Hospital
 2018-10 PHASE2
NCT03736837 COMPLETED
Non Small Cell Lung Cancer
Tianjin Medical University Cancer Institute and Hospital
 2018-12-01 PHASE2
NCT02362230 TERMINATED
Metastatic Breast Cancer
Sun Yat-sen University
 2015-01 PHASE2
NCT02264210 COMPLETED
Lung Neoplasms; Squamous Cell Lung Cancer; Adenocarcinoma of the Lung; Adenosquamous Cell Lung Cancer; Large Cell Lung Cancer; Bronchial Neoplasms; Stage IB Non-small Cell Lung Cancer
Sun Yat-sen University
 2015-01 PHASE2
NCT03992885 UNKNOWN
Non-squamous Non-small Cell Lung Cancer
Tianjin Medical University Cancer Institute and Hospital
 2019-07-01 PHASE3
NCT03754530 UNKNOWN
Non-Small Cell Lung Cancer; Brain Metastases
Betta Pharmaceuticals Co., Ltd.
 2018-12-01 PHASE2
NCT02882984 UNKNOWN
Stage IV EGFR Mutated NSCL With Brain Metastases
Sichuan Provincial People's Hospital
 2015-03 PHASE3
NCT03766490 UNKNOWN
Non-Small-Cell Lung
The First Affiliated Hospital of Soochow University
 2019-03-30
NCT02737774 UNKNOWN
Lung Adenocarcinoma
Henan Cancer Hospital
 2016-04-13 PHASE2
NCT03402464 UNKNOWN
EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma
Peking University Cancer Hospital & Institute
 2018-01 PHASE2
NCT03346811 UNKNOWN
Plasma EGFR Mutation-positive Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2017-11-18 PHASE2
NCT03123484 UNKNOWN
Non Small Cell Lung Cancer
China Medical University, China
 2017-04 PHASE2
NCT03151161 UNKNOWN
Lung, Carcinoma
Sun Yat-sen University
 2015-12 PHASE2
NCT01963195 UNKNOWN
NSCLC
Anhui Medical University
 2014-02 PHASE2
NCT02125240 UNKNOWN
EGFR Positive Non-small Cell Lung Cancer; Adenocarcinoma
Betta Pharmaceuticals Co., Ltd.
 2014-09 PHASE3
NCT01973725 COMPLETED
Esophageal Squamous Cell Carcinoma
Yuhong Li
 2013-10 PHASE2
NCT03222622 TERMINATED
Mild to Moderate Psoriasis
Betta Pharmaceuticals Co., Ltd.
 2017-11-29 PHASE2
NCT02215356 UNKNOWN
Non-small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2014-08 PHASE2
NCT02934256 COMPLETED
Vestibular Schwannoma; Neurofibromatosis Type 2
Li Peng
 2016-07 PHASE2
NCT02883543 UNKNOWN
Non-small Cell Lung Cancer
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
 2016-06 PHASE3
NCT02044328 COMPLETED
Non-small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2014-01 PHASE2
NCT02960607 UNKNOWN
Carcinoma, Non-Small-Cell Lung
Chinese Academy of Medical Sciences
 2016-11 PHASE2
NCT02375581 UNKNOWN
Esophageal Cancer
First People's Hospital of Hangzhou
 2015-01 PHASE2
NCT02404675 UNKNOWN
NSCLC
Betta Pharmaceuticals Co., Ltd.
 2015-04 PHASE4
NCT02961270 UNKNOWN
Non-small Cell Lung Cancer
Chinese Academy of Medical Sciences
 2016-11 PHASE2
NCT03153358 UNKNOWN
Lung Cancer Stage IV
Sichuan Cancer Hospital and Research Institute
 2017-06-02 PHASE2
NCT01744925 UNKNOWN
Non-small Cell Lung Cancer
Tianjin Medical University Cancer Institute and Hospital
 2012-10 PHASE2
NCT02283424 UNKNOWN
Neoplasms, Therapy-Associated
Chinese PLA General Hospital
 2014-10 PHASE4
NCT02744664 COMPLETED
Lung Neoplasms
Fuda Cancer Hospital, Guangzhou
 2016-04-01 PHASE4
NCT01665417 UNKNOWN
EGFR Positive Non-small Cell Lung Cancer; Adenocarcinoma
Betta Pharmaceuticals Co., Ltd.
 2012-08 PHASE4
NCT02194556 UNKNOWN
EGFR Positive Non-small Cell Lung Cancer; Adenocarcinoma
Betta Pharmaceuticals Co., Ltd.
 2014-07 PHASE4
NCT02272127 UNKNOWN
NSCLC
Nanfang Hospital, Southern Medical University
 2014-07 PHASE2
NCT02801435 COMPLETED
Psoriasis
Betta Pharmaceuticals Co., Ltd.
 2016-09-17 PHASE1
NCT03544814 COMPLETED
Lung Adenocarcinoma; EGFR Activating Mutation
Shanghai Chest Hospital
 2015-01-01 PHASE2
NCT02574091 COMPLETED
Psoriasis
Betta Pharmaceuticals Co., Ltd.
 2015-11-26 PHASE1
NCT02889692 COMPLETED
Cancer
Shanghai University of Traditional Chinese Medicine
 2013-03 PHASE3
NCT02407366 UNKNOWN
Non-small Cell Lung Cancer
People's Hospital of Guangxi Zhuang Autonomous Region
 2014-12 PHASE2
NCT01843647 UNKNOWN
Non-small-cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2013-04 PHASE2
NCT02031601 UNKNOWN
Non-Small-Cell Lung Cancer
Qilu Hospital of Shandong University
 2014-01 PHASE4
NCT02738983 UNKNOWN
Non-small Cell Lung Cancer; Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
Hangzhou Cancer Hospital
 2012-01 PHASE2
NCT02328261 UNKNOWN
Nasopharyngeal Carcinoma
Betta Pharmaceuticals Co., Ltd.
 2014-11 PHASE2
NCT01719536 COMPLETED
NSCLC
Betta Pharmaceuticals Co., Ltd.
 2012-12 PHASE3
NCT01926171 UNKNOWN
Non-small-cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2013-06 PHASE4
NCT01707329 UNKNOWN
Non-small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2012-09 PHASE2
NCT02027090 UNKNOWN
Non-small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2014-01 PHASE2
NCT02033148 WITHDRAWN
Unspecified Adult Solid Tumor, Protocol Specific
Roswell Park Cancer Institute
 2014-08 PHASE1
NCT02375022 UNKNOWN
Lung Cancer
Zhejiang University
 2015-03 PHASE2
NCT02103257 UNKNOWN
EGFR Positive Non-small Cell Lung Cancer; Adenocarcinoma
Betta Pharmaceuticals Co., Ltd.
 2014-03 PHASE4
NCT02062515 UNKNOWN
Non-small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2014-02 PHASE2
NCT02278458 UNKNOWN
Pancreatic Cancer
Betta Pharmaceuticals Co., Ltd.
 2014-10 PHASE1
NCT02430974 UNKNOWN
Carcinoma, Non-Small-Cell Lung
Nanfang Hospital, Southern Medical University
 2011-01 PHASE2
NCT02009605 UNKNOWN
Squamous Cell Carcinoma of Lung
Zhejiang University
 2015-03 PHASE2
NCT02024633 UNKNOWN
Pancreatic Cancer
Betta Pharmaceuticals Co., Ltd.
 2013-12 PHASE1
NCT01646450 UNKNOWN
Non-Small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2012-07 PHASE4
NCT01720901 SUSPENDED
Non-small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2013-02 PHASE4
NCT01929200 UNKNOWN
Non-small-cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2013-08 PHASE2
NCT01690390 UNKNOWN
NSCLC
Betta Pharmaceuticals Co., Ltd.
 2012-09 PHASE2
NCT02066870 UNKNOWN
Non-small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2014-01 PHASE1
NCT01855854 COMPLETED
Adenocarcinoma of the Gastroesophageal Junction; Esophageal Carcinoma
Betta Pharmaceuticals Co., Ltd.
 2013-05 PHASE2
NCT02191059 UNKNOWN
Non Small Cell Lung Cancer
Shandong Cancer Hospital and Institute
 2014-07 PHASE2
NCT01724801 COMPLETED
Brain Metastasis; Non Small Cell Lung Cancer
Guangdong Association of Clinical Trials
 2012-10-14 PHASE3
NCT01688713 UNKNOWN
Brain Metastases; Non-small Cell Lung Cancer
Zhejiang Cancer Hospital
 2012-08 PHASE2
NCT01514877 COMPLETED
Lung Cancer; Metastatic Cancer
Zhejiang Cancer Hospital
 2012-01 PHASE2
NCT01465243 COMPLETED
Non-small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2011-09 PHASE4
NCT01516983 COMPLETED
Non-small Cell Lung Cancer; Brain Metastases
Betta Pharmaceuticals Co., Ltd.
 2011-12 PHASE1; PHASE2
NCT01534585 COMPLETED
Nasopharyngeal Carcinoma
Taizhou Hospital
 2012-02 PHASE1; PHASE2
NCT02486354 COMPLETED
Non-small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2010-03 PHASE3
NCT01040780 COMPLETED
Non-small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2009-02 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-05-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Icotinib hydrochloride acts as a potent, selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with an IC50 of 5 nM, competitively binding to the adenosine triphosphate binding site of the EGFR kinase domain to block autophosphorylation and downstream signal transduction pathways. This molecular inhibition suppresses tumor cell proliferation and survival, providing direct therapeutic efficacy in halting disease progression in EGFR-mutated non-small cell lung cancer and other advanced malignancies.

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>).

Jump to

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