Multiple clinical trials across early to late phases evaluate the selective kinase inhibitor furmonertinib mesylate in non-small cell lung cancer harboring diverse EGFR and HER2 alterations or central nervous system metastases, alongside pharmacology studies in healthy volunteers. Sponsored by academic medical centers and industry partners including Allist Pharmaceuticals and ArriVent BioPharma, these studies encompass recruiting, active not recruiting, completed, and terminated statuses. Collectively, these investigations aim to establish the drug's therapeutic efficacy, safety profile, and pharmacokinetics in target populations.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07229599 | RECRUITING | Advanced Lung Cancer |
Minghui Pharmaceutical (Hangzhou) Ltd |
2025-05-09 | PHASE1; PHASE2 |
| NCT06970639 | RECRUITING | NSCLC Patients With Brain Metastasis |
Allist Pharmaceuticals, Inc. |
2024-09-26 | PHASE3 |
| NCT07622186 | RECRUITING | Non-Small Cell Lung Cancer |
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
2026-07-15 | PHASE2 |
| NCT07304739 | RECRUITING | Non Small Cell Lung Cancer |
Tianjin Medical University Cancer Institute and Hospital |
2025-12-22 | PHASE2 |
| NCT06969781 | NOT_YET_RECRUITING | Lung Cancer (NSCLC) |
Shanghai Chest Hospital |
2025-05 | |
| NCT07348965 | RECRUITING | NSCLC (Advanced Non-small Cell Lung Cancer); Leptomeningeal Metastasis; Furmonertinib; EGFR Activating Mutation |
Guangzhou University of Traditional Chinese Medicine |
2026-03-01 | |
| NCT05987826 | RECRUITING | Non-Small Cell Lung Cancer |
Shanghai Zhongshan Hospital |
2023-09-19 | PHASE2 |
| NCT06868732 | RECRUITING | Advanced Non-small Cell Lung Cancer |
Jiangsu Alphamab Biopharmaceuticals Co., Ltd |
2025-04-02 | PHASE1 |
| NCT06728865 | RECRUITING | Non-small Cell Lung Cancer (NSCLC); EGFR Mutation-Positive Lung Cancer; Brain Metastases; Leptomeningeal Metastases; Intracranial Tumor Progression |
Li-kun Chen |
2024-09-04 | PHASE2 |
| NCT07517640 | NOT_YET_RECRUITING | Non-small Cell Lung Cancer |
Shanghai Pulmonary Hospital, Shanghai, China |
2026-04-01 | PHASE2 |
| NCT06452433 | NOT_YET_RECRUITING | Non-small Cell Lung Cancer |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2024-06-01 | PHASE2 |
| NCT07655622 | RECRUITING | Non-Small-Cell Lung Cancer |
Second Affiliated Hospital of Nanchang University |
2026-07-03 | PHASE1; PHASE2 |
| NCT07482605 | NOT_YET_RECRUITING | Lung Cancer (NSCLC); Malignant Pleural Effusions (Mpe)- Pleurodesis |
Jiangmen Central Hospital |
2026-07-01 | PHASE2 |
| NCT06945705 | RECRUITING | NSCLC |
Henan Cancer Hospital |
2025-04-02 | PHASE2 |
| NCT07087223 | RECRUITING | Non Small Cell Lung Cancer NSCLC |
Peking University Cancer Hospital & Institute |
2025-04-08 | PHASE1; PHASE2 |
| NCT06674343 | RECRUITING | Advanced or Metastatic Non-small Cell Lung Cancer |
Peking Union Medical College Hospital |
2024-07-15 | PHASE3 |
| NCT06319950 | NOT_YET_RECRUITING | Lung Cancer, Nonsmall Cell |
Taizhou Hospital |
2024-04-01 | PHASE2 |
| NCT06192849 | RECRUITING | Non Small Cell Lung Cancer; EGFR Exon 20 Insertion Mutation |
Juan LI, MD |
2023-12-31 | PHASE2 |
| NCT06652048 | RECRUITING | Non-Small Cell Lung Cancer |
Jialei Wang |
2024-10-01 | PHASE2 |
| NCT04853342 | RECRUITING | Non-small Cell Lung Carcinoma |
Allist Pharmaceuticals, Inc. |
2021-06-07 | PHASE3 |
| NCT07169994 | RECRUITING | Advanced Solid Tumors; Breast Cancer; Non Small Cell Lung Cancer |
MediLink Therapeutics (Suzhou) Co., Ltd. |
2025-09-02 | PHASE1; PHASE2 |
| NCT05994131 | RECRUITING | NSCLC |
InxMed (Shanghai) Co., Ltd. |
2023-07-13 | PHASE1; PHASE2 |
| NCT05445310 | UNKNOWN | Non-small Cell Lung Cancer |
Peking Union Medical College Hospital |
2022-08-06 | PHASE2 |
| NCT07193160 | NOT_YET_RECRUITING | NSCLC (Non-small Cell Lung Cancer) |
Fudan University |
2025-11-01 | PHASE2 |
| NCT06962865 | RECRUITING | Non-Small Cell Lung Cancer |
RemeGen Co., Ltd. |
2025-06-30 | PHASE2 |
| NCT07365410 | NOT_YET_RECRUITING | Non-small Cell Lung Cancer (NSCLC); Brain Metastases; Furmonertinib; EGFR Mutation |
Tianjin Medical University Cancer Institute and Hospital |
2026-01 | PHASE2 |
| NCT06812871 | COMPLETED | Non-small Cell Lung Cancer Metastatic |
Sun Yat-sen University |
2024-01-01 | PHASE2 |
| NCT06483672 | NOT_YET_RECRUITING | Adenocarcinoma of Lung Metastatic to Brain |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2024-07 | PHASE2 |
| NCT05465343 | COMPLETED | Furmonertinib; EGFR-mutation; NSCLC; Brain Metastases |
Peking Union Medical College |
2022-07-11 | PHASE2 |
| NCT06585644 | NOT_YET_RECRUITING | Lung Cancer (NSCLC) |
Shanghai Pulmonary Hospital, Shanghai, China |
2024-10-01 | PHASE2 |
| NCT05430802 | ACTIVE_NOT_RECRUITING | Non-small Cell Lung Cancer |
Tang-Du Hospital |
2022-02-24 | PHASE2 |
| NCT05821933 | UNKNOWN | NSCLC |
RemeGen Co., Ltd. |
2023-09-07 | PHASE1; PHASE2 |
| NCT06537297 | NOT_YET_RECRUITING | Non-small Cell Lung Cancer |
Hunan Province Tumor Hospital |
2024-09-30 | PHASE2 |
| NCT05607550 | ACTIVE_NOT_RECRUITING | Metastatic Non-Small Cell Lung Cancer; Advanced Non-Small Cell Lung Cancer; EGFR Exon 20 Mutations |
ArriVent BioPharma, Inc. |
2023-06-01 | PHASE3 |
| NCT06339242 | UNKNOWN | NSCLC |
Jiangsu Province Nanjing Brain Hospital |
2024-01-01 | PHASE2 |
| NCT06185400 | NOT_YET_RECRUITING | Non Small Cell Lung Cancer; ERBB2 Mutation-Related Tumors; ERBB2 Gene Duplication; Disitamab Vedotin |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2024-02-01 | PHASE2 |
| NCT05466149 | ACTIVE_NOT_RECRUITING | NSCLC |
Allist Pharmaceuticals, Inc. |
2022-09-27 | PHASE2 |
| NCT05364073 | ACTIVE_NOT_RECRUITING | Non-Small Cell Lung Cancer (NSCLC); Metastatic Non-Small Cell Lung Cancer; Advanced Non-Small Cell Lung Cancer; HER2 Exon 20 Mutations; EGFR Exon 20 Mutations; EGFR Uncommon Mutations, Including G719X and S768I |
ArriVent BioPharma, Inc. |
2022-06-30 | PHASE1 |
| NCT06394674 | RECRUITING | Non-Small Cell Lung Cancer |
Changhai Hospital |
2024-05-01 | PHASE2 |
| NCT05813522 | UNKNOWN | Non Small Cell Lung Cancer |
First Affiliated Hospital of Zhejiang University |
2022-04-15 | PHASE2 |
| NCT06643000 | RECRUITING | Non-small Cell Lung Cancer; Leptomeningeal Metastasis; EGFR Gene Mutation |
Henan Cancer Hospital |
2024-12-20 | |
| NCT05334277 | RECRUITING | Non-small Cell Lung Cancer |
Sun Yat-sen University |
2022-05-06 | PHASE2 |
| NCT05379803 | RECRUITING | Non-Small Cell Lung Cancer |
Hunan Province Tumor Hospital |
2022-05-01 | PHASE2 |
| NCT04858958 | COMPLETED | NSCLC |
Allist Pharmaceuticals, Inc. |
2020-08-10 | PHASE1 |
| NCT05165355 | UNKNOWN | NSCLC; EGF-R Positive Non-Small Cell Lung Cancer |
Tongji University |
2021-12-28 | PHASE2 |
| NCT05847764 | UNKNOWN | Non Small Cell Lung Cancer; ERBB2 Mutation-Related Tumors; RC48; Disitamab Vedotin |
Sun Yat-sen University |
2023-05 | PHASE2 |
| NCT04970693 | UNKNOWN | Non-small Cell Lung Cancer; Oligoprogressive |
Sun Yat-sen University |
2021-06-01 | PHASE2 |
| NCT05209256 | UNKNOWN | NSCLC |
The First Affiliated Hospital of Henan University of Science and Technology |
2022-03-01 | PHASE2; PHASE3 |
| NCT05548348 | UNKNOWN | Non-small Cell Lung Cancer; EGFR G719X; EGFR L861Q; EGFR S768I |
Chongqing University Cancer Hospital |
2022-09-26 | PHASE2 |
| NCT05255406 | UNKNOWN | Non-Small-Cell Lung Cancer |
Fudan University |
2021-12-09 | PHASE2 |
| NCT04895930 | UNKNOWN | Non-Small-Cell Lung Cancer |
Shanghai Chest Hospital |
2021-10-12 | PHASE2 |
| NCT05503667 | RECRUITING | Lung Adenocarcinoma Stage III; Lung Adenocarcinoma Stage IV; EGFR Gene Mutation |
Shanghai Pulmonary Hospital, Shanghai, China |
2022-02-01 | PHASE2 |
| NCT04671303 | COMPLETED | Lung Cancer |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2021-01-01 | PHASE2 |
| NCT04965831 | UNKNOWN | Lung Adenocarcinoma |
Tianjin Medical University Cancer Institute and Hospital |
2021-08-01 | PHASE2 |
| NCT05079022 | UNKNOWN | Adenocarcinoma of Lung |
Peking University People's Hospital |
2021-10 | PHASE1; PHASE2 |
| NCT04982900 | UNKNOWN | Multiple Primary Lung Cancers |
Ruijin Hospital |
2021-10-01 | PHASE2 |
| NCT05364073 | Recruiting | Non-Small Cell Lung Cancer (NSCLC)|Metastatic Non-Small Cell Lung Cancer|Advanced Non-Small Cell Lung Cancer|HER2 Exon 20 Mutations|EGFR Exon 20 Mutations|EGFR Uncommon Mutations Including G719X and S768I |
ArriVent BioPharma Inc. |
2022-06-30 | Phase 1 |
| NCT04958967 | WITHDRAWN | NSCLC |
Allist Pharmaceuticals, Inc. |
2021-10-01 | PHASE1 |
| NCT03787992 | ACTIVE_NOT_RECRUITING | Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non-small Cell Lung Cancer |
Allist Pharmaceuticals, Inc. |
2019-05-30 | PHASE3 |
| NCT03127449 | TERMINATED | Advanced NSCLC |
Allist Pharmaceuticals, Inc. |
2017-06-01 | |
| NCT03452592 | TERMINATED | Advanced NSCLC Patients With T790M |
Allist Pharmaceuticals, Inc. |
2018-04-30 | PHASE2 |
| NCT02973763 | TERMINATED | NSCLC |
Allist Pharmaceuticals, Inc. |
2016-12-30 | PHASE1 |
| NCT03941340 | COMPLETED | Healthy Male Volunteers |
Allist Pharmaceuticals, Inc. |
2019-04-08 | PHASE1 |
| NCT03926182 | COMPLETED | Healthy Male Volunteers |
Allist Pharmaceuticals, Inc. |
2019-02-19 | PHASE1 |
| NCT03941340 | Completed | Healthy Male Volunteers |
Allist Pharmaceuticals Inc. |
2019-04-08 | Phase 1 |
| NCT03926182 | Completed | Healthy Male Volunteers |
Allist Pharmaceuticals Inc. |
2019-02-19 | Phase 1 |
| NCT03452592 | Unknown status | Advanced NSCLC Patients With T790M |
Allist Pharmaceuticals Inc. |
2018-04-30 | Phase 2 |
| NCT03127449 | Unknown status | Advanced NSCLC |
Allist Pharmaceuticals Inc. |
2017-06-01 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2025-11-17)
Check the
Furmonertinib Mesylate (AST2818, Alflutinib)
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>).
- Furmonertinib Mesylate (AST2818, Alflutinib) Solubility in DMSO
- Furmonertinib Mesylate (AST2818, Alflutinib) Stock Solution
- Furmonertinib Mesylate (AST2818, Alflutinib) Storage
- Furmonertinib Mesylate (AST2818, Alflutinib) Stability
- Furmonertinib Mesylate (AST2818, Alflutinib) Molecular Weight
- Furmonertinib Mesylate (AST2818, Alflutinib) SMILES
- Furmonertinib Mesylate (AST2818, Alflutinib) CAS Number
- Furmonertinib Mesylate (AST2818, Alflutinib) Chemical Structure (2D and 3D)
- Furmonertinib Mesylate (AST2818, Alflutinib) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.