Clinical Trials

Numerous clinical trials across various phases evaluate almonertinib primarily for non-small cell lung cancer (NSCLC) harboring EGFR-activating or T790M resistance mutations, including unresectable disease, pulmonary adenosquamous carcinoma, and brain or leptomeningeal metastases. Encompassing recruiting, active, and pending recruitment statuses, these multicenter studies are supported by industry sponsors such as Jiangsu Hansoh Pharmaceutical Co. Ltd. alongside academic institutions including Shanghai Chest Hospital and the Guangdong Association of Clinical Trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06474455 RECRUITING
Advanced Solid Tumors
Shanghai Hengrui Pharmaceutical Co., Ltd.
 2024-07-02 PHASE1; PHASE2
NCT07699952 NOT_YET_RECRUITING
Lung Cancer (NSCLC); EGFR Activating Mutation; HER2
Yongsheng Wang
 2026-09-09 PHASE2
NCT05768490 RECRUITING
Brain Metastases; Radiotherapy; EGFR Activating Mutation
Sun Yat-sen University
 2023-03-15 PHASE3
NCT06452433 NOT_YET_RECRUITING
Non-small Cell Lung Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2024-06-01 PHASE2
NCT05800223 RECRUITING
Non-small Cell Lung Cancer Metastatic
Shanghai Cancer Hospital, China
 2023-01-01 PHASE3
NCT05503888 NOT_YET_RECRUITING
Relapsed or Advanced Non-small Cell Lung Cancer
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
 2022-10-01 PHASE1; PHASE2
NCT06951464 RECRUITING
Non-Small Cell Lung Cancer
Sichuan University
 2025-06-25 PHASE2
NCT06947811 RECRUITING
EGFR Tyrosine Kinase Inhibitors Plus Cyclin-dependent Kinase 4/6 Inhibitor
Sun Yat-sen University
 2025-06-09 PHASE1; PHASE2
NCT04841811 ACTIVE_NOT_RECRUITING
Lung Cancer
Guangdong Association of Clinical Trials
 2022-06-20 PHASE3
NCT06043973 RECRUITING
Advanced Non-small Cell Lung Cancer
Qianfoshan Hospital
 2023-09-01 PHASE3
NCT04423185 RECRUITING
Rare Tumor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2020-08-15 PHASE2
NCT06463171 UNKNOWN
Lung Cancer Non-small Cell Stage IV
Shanghai Pulmonary Hospital, Shanghai, China
 2024-06 PHASE2
NCT04762459 ENROLLING_BY_INVITATION
Non-small Cell Lung Carcinoma
Chinese Academy of Medical Sciences
 2021-08-01 PHASE3
NCT06300424 ACTIVE_NOT_RECRUITING
Non Small Cell Lung Cancer; EGFR Gene Mutation
Guangdong Provincial People's Hospital
 2024-04-01 PHASE2
NCT06481566 UNKNOWN
Non-small Cell Lung Cancer
Chongqing University Cancer Hospital
 2024-06-21
NCT06092268 UNKNOWN
Advanced Solid Tumors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
 2023-10 PHASE1; PHASE2
NCT06585059 NOT_YET_RECRUITING
Advanced Non-small Cell Lung Cancer
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
 2024-09 PHASE1
NCT05994339 UNKNOWN
Lung Cancer Stage III
Laibin People's Hospital
 2023-09-01 PHASE2; PHASE3
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
NCT05534113 UNKNOWN
Non-small Cell Lung Cancer
The First Affiliated Hospital with Nanjing Medical University
 2022-12-01 PHASE2
NCT06110663 UNKNOWN
Non-Small Cell Lung Cancer
Jiangsu Hansoh Pharmaceutical Co., Ltd.
 2023-12-30 PHASE3
NCT05826483 UNKNOWN
Malignant Tumor of Lung; Poor Performance Status
Guangzhou Institute of Respiratory Disease
 2022-01-01 PHASE1
NCT04951635 RECRUITING
Non-small Cell Lung Cancer
Jiangsu Hansoh Pharmaceutical Co., Ltd.
 2021-03-18 PHASE3
NCT04687241 ACTIVE_NOT_RECRUITING
Non-small Cell Lung Cancer
Jiangsu Hansoh Pharmaceutical Co., Ltd.
 2021-04-30 PHASE3
NCT04808752 UNKNOWN
Lung Cancer
Zhejiang Cancer Hospital
 2021-07-09 PHASE2
NCT04870190 UNKNOWN
NSCLC
Shanghai Chest Hospital
 2021-06-01 PHASE3
NCT04905550 UNKNOWN
Non-Small Cell Lung Cancer (NSCLC)
Chongqing University Cancer Hospital
 2021-03-01 PHASE2
NCT04944069 UNKNOWN
NSCLC; Leptomeningeal Metastasis; EGFR Activating Mutation
Second Affiliated Hospital of Nanchang University
 2021-07
NCT04882345 UNKNOWN
Lung Cancer; EGFR Gene Mutation
Shanghai Chest Hospital
 2021-07-15 PHASE2
NCT05430386 UNKNOWN
Non Small Cell Lung Cancer
Jiangsu Hansoh Pharmaceutical Co., Ltd.
 2022-01-05 PHASE1
NCT04354961 UNKNOWN
Pulmonary Adenosquamous Carcinoma
Fujian Cancer Hospital
 2021-05-07 PHASE2
NCT04785742 UNKNOWN
Safety of Almonertinib
Sun Yat-sen University
 2020-12-31 PHASE2
NCT05662813 UNKNOWN
Non-small Cell Lung Cancer
West China Hospital
 2022-11-09 PHASE2
NCT04785729 UNKNOWN
Safety
Sun Yat-sen University
 2020-12-31 PHASE2
NCT04951648 UNKNOWN
Non-small Cell Lung Cancer
Jiangsu Hansoh Pharmaceutical Co., Ltd.
 2021-07-15 PHASE3
NCT05223595 UNKNOWN
Metastatic Non-Small Cell Lung Cancer
Changchun GeneScience Pharmaceutical Co., Ltd.
 2021-04-02 PHASE1
NCT04553887 UNKNOWN
Non Small Cell Lung Cancer
Tianjin Medical University Cancer Institute and Hospital
 2020-11-01 PHASE2
NCT04755738 UNKNOWN
Advanced Non Small Cell Lung Cancer
Qianfoshan Hospital
 2022-01-01 PHASE2
NCT05048134 TERMINATED
Advanced Malignancies
Jiangsu HengRui Medicine Co., Ltd.
 2021-10-25 PHASE1
NCT04778800 UNKNOWN
NSCLC; Brain Metastases; Leptomeningeal Metastasis
Henan Cancer Hospital
 2021-03-20
NCT04455594 UNKNOWN
Non-Small Cell Lung Cancer Stage IIIA
The First Affiliated Hospital of Guangzhou Medical University
 2020-10 PHASE2
NCT04685070 ACTIVE_NOT_RECRUITING
Non-small Cell Lung Cancer Stage III
Shanghai Pulmonary Hospital, Shanghai, China
 2021-12-14 PHASE2
NCT03904823 UNKNOWN
EGFR-mutant Non-Small Cell Lung Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2019-04-25 PHASE2
NCT04643847 UNKNOWN
EGFR Positive Non-small Cell Lung Cancer; Brain Metastases
First People's Hospital of Hangzhou
 2020-11-30 PHASE2
NCT04500717 UNKNOWN
Non Small Cell Lung Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2020-10 PHASE3
NCT04952168 UNKNOWN
NSCLC, Stage III
Yuan Chen
 2021-06-02 PHASE2
NCT04841811 Recruiting
Lung Cancer
Guangdong Association of Clinical Trials|Jiangsu Hansoh Pharmaceutical Co. Ltd.
 2022-06-20 Phase 3
NCT04978753 UNKNOWN
Non-small Cell Lung Cancer; Brain Metastases
Li-kun Chen
 2021-05-01 PHASE2
NCT04592666 UNKNOWN
Lung Cancer, Non-small Cell; EGFR T790M; EGFR Gene Mutation
Fudan University
 2020-10-09 PHASE2
NCT04636593 UNKNOWN
Non Small Cell Lung Cancer; Stage III NSCLC; EGFR Activating Mutation
First People's Hospital of Hangzhou
 2020-08-01 PHASE2
NCT04500704 UNKNOWN
Non Small Cell Lung Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2020-10 PHASE3
NCT04882345 Unknown status
Lung Cancer|EGFR Gene Mutation
Shanghai Chest Hospital|Jiangsu Hansoh Pharmaceutical Co. Ltd.
 2021-07-15 Phase 2
NCT04944069 Not yet recruiting
NSCLC|Leptomeningeal Metastasis|EGFR Activating Mutation
Second Affiliated Hospital of Nanchang University|Jiangsu Hansoh Pharmaceutical Co. Ltd.
 2021-07 Not Applicable
NCT04870190 Not yet recruiting
NSCLC
Shanghai Chest Hospital
 2021-06-01 Phase 3
NCT04354961 Recruiting
Pulmonary Adenosquamous Carcinoma
Fujian Cancer Hospital|Jiangsu Hansoh Pharmaceutical Co. Ltd.
 2021-05-07 Phase 2
NCT04687241 Active not recruiting
Non-small Cell Lung Cancer
Jiangsu Hansoh Pharmaceutical Co. Ltd.
 2021-04-30 Phase 3
NCT03849768 UNKNOWN
Non Small Cell Lung Cancer
Jiangsu Hansoh Pharmaceutical Co., Ltd.
 2019-02-01 PHASE3
NCT04646824 UNKNOWN
Non-Small Cell Lung Cancer Metastatic
Tianjin Medical University Cancer Institute and Hospital
 2020-11-19 PHASE2
NCT02981108 UNKNOWN
Nonsmall Cell Lung Cancer
Jiangsu Hansoh Pharmaceutical Co., Ltd.
 2017-05-08 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-11)

Check the Almonertinib (HS-10296) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Almonertinib selectively binds to and inhibits EGFR-activating mutations as well as the T790M resistance mutation while sparing wild-type EGFR, thereby blocking downstream receptor autophosphorylation and oncogenic signaling cascades. This pathway inhibition suppresses tumor cell proliferation and induces apoptosis, offering clinical efficacy against advanced or metastatic EGFR-mutant non-small cell lung 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.