Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate icotinib primarily for EGFR-mutated non-small cell lung cancer—including adenocarcinoma, squamous cell, and large cell subtypes—as well as non-oncology conditions such as neurofibromatosis type 2 and vestibular schwannoma. Conducted by industrial entities like Betta Pharmaceuticals Co., Ltd. alongside academic medical centers, these completed, recruiting, active, and unverified studies assess icotinib as monotherapy, neoadjuvant treatment, or combination therapy with chemoradiation and adjuvant protocols.
| 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 |
| 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 |
| 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 |
| 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 |
| NCT02125240 | UNKNOWN | EGFR Positive Non-small Cell Lung Cancer; Adenocarcinoma |
Betta Pharmaceuticals Co., Ltd. |
2014-09 | PHASE3 |
| NCT01963195 | UNKNOWN | NSCLC |
Anhui Medical University |
2014-02 | PHASE2 |
| 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 |
| NCT02960607 | UNKNOWN | Carcinoma, Non-Small-Cell Lung |
Chinese Academy of Medical Sciences |
2016-11 | PHASE2 |
| NCT02044328 | COMPLETED | Non-small Cell Lung Cancer |
Betta Pharmaceuticals Co., Ltd. |
2014-01 | 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 |
| NCT02272127 | UNKNOWN | NSCLC |
Nanfang Hospital, Southern Medical University |
2014-07 | PHASE2 |
| 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 |
| 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 |
| NCT01926171 | UNKNOWN | Non-small-cell Lung Cancer |
Betta Pharmaceuticals Co., Ltd. |
2013-06 | PHASE4 |
| NCT01719536 | COMPLETED | NSCLC |
Betta Pharmaceuticals Co., Ltd. |
2012-12 | PHASE3 |
| NCT01707329 | UNKNOWN | Non-small Cell Lung Cancer |
Betta Pharmaceuticals Co., Ltd. |
2012-09 | PHASE2 |
| NCT02883543 | Unknown status | Non-small Cell Lung Cancer |
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University |
2016-06 | Phase 3 |
| NCT02033148 | WITHDRAWN | Unspecified Adult Solid Tumor, Protocol Specific |
Roswell Park Cancer Institute |
2014-08 | PHASE1 |
| NCT02027090 | UNKNOWN | Non-small Cell Lung Cancer |
Betta Pharmaceuticals Co., Ltd. |
2014-01 | PHASE2 |
| NCT02103257 | UNKNOWN | EGFR Positive Non-small Cell Lung Cancer; Adenocarcinoma |
Betta Pharmaceuticals Co., Ltd. |
2014-03 | PHASE4 |
| NCT02375022 | UNKNOWN | Lung Cancer |
Zhejiang University |
2015-03 | PHASE2 |
| 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 |
| 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 |
| NCT02024633 | UNKNOWN | Pancreatic Cancer |
Betta Pharmaceuticals Co., Ltd. |
2013-12 | PHASE1 |
| 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 |
| NCT01843647 | Unknown status | Non-small-cell Lung Cancer |
Betta Pharmaceuticals Co. Ltd. |
2013-04 | Phase 2 |
| 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 (BPI-2009H)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
- Icotinib (BPI-2009H) Solubility in DMSO
- Icotinib (BPI-2009H) Stock Solution
- Icotinib (BPI-2009H) Storage
- Icotinib (BPI-2009H) Stability
- Icotinib (BPI-2009H) Molecular Weight
- Icotinib (BPI-2009H) SMILES
- Icotinib (BPI-2009H) CAS Number
- Icotinib (BPI-2009H) Chemical Structure (2D and 3D)
- Icotinib (BPI-2009H) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.