Numerous clinical trials across early to late development phases evaluate ensartinib for ALK-positive non-small cell lung cancer, central nervous system metastases, and recurrent or refractory solid neoplasms. Conducted by industry sponsors such as Betta Pharmaceuticals alongside academic and governmental institutions like the National Cancer Institute and Shanghai Pulmonary Hospital, trial recruitment statuses range from not yet recruiting to completed. Overall, these studies assess ensartinib as both monotherapy and combination regimens across neoadjuvant, adjuvant, and advanced disease settings.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07235306 | NOT_YET_RECRUITING | NSCLC Stage III; Ensartinib; Chemoradiotherapy; ALK |
Shanghai Pulmonary Hospital, Shanghai, China |
2025-12-01 | PHASE2 |
| NCT06955325 | NOT_YET_RECRUITING | Non-Small Cell Lung Cancer |
The First Affiliated Hospital of Guangzhou Medical University |
2025-05 | PHASE3 |
| NCT06772610 | NOT_YET_RECRUITING | NSCLC; ALK; Stage I; Adjuvant Treatment |
Shanghai Pulmonary Hospital, Shanghai, China |
2025-03-15 | PHASE2 |
| NCT07448116 | RECRUITING | Solid Advanced Tumor |
Betta Pharmaceuticals Co., Ltd. |
2026-01-31 | PHASE1; PHASE2 |
| NCT06780839 | NOT_YET_RECRUITING | NSCLC, Stage I, II, IIIA, IIIB |
Peking University Cancer Hospital & Institute |
2025-01-15 | PHASE2 |
| NCT07671560 | NOT_YET_RECRUITING | ALK-positive, Locally Advanced or Metastatic (TNM Stage IIIB-IV) Non-small Cell Lung Cancer That Has Developed Resistance to Prior Treatment With Lorlatinib |
Qiming Wang |
2026-07-01 | PHASE4 |
| NCT06779539 | NOT_YET_RECRUITING | Non-Small Cell Lung Cancer |
West China Hospital |
2025-01-15 | PHASE2 |
| NCT07354061 | RECRUITING | NSCLC (Non-small Cell Lung Cancer) |
Tang-Du Hospital |
2026-03-25 | PHASE1; PHASE2 |
| NCT06563999 | RECRUITING | Lung Cancer Stage III; Mutation |
Sun Yat-sen University |
2024-11-01 | PHASE2 |
| NCT04837716 | ACTIVE_NOT_RECRUITING | Metastatic Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8 |
M.D. Anderson Cancer Center |
2021-03-18 | PHASE1 |
| NCT05241028 | RECRUITING | Non-small Cell Lung Cancer |
Hebei Medical University Fourth Hospital |
2022-05-01 | PHASE2 |
| NCT03420508 | ACTIVE_NOT_RECRUITING | Melanoma |
Memorial Sloan Kettering Cancer Center |
2018-01-10 | PHASE2 |
| NCT06762327 | NOT_YET_RECRUITING | Solid Tumors |
Nanjing First Hospital, Nanjing Medical University |
2025-02-28 | PHASE2 |
| NCT02767804 | ACTIVE_NOT_RECRUITING | Non-small Cell Lung Cancer |
Xcovery Holdings, Inc. |
2016-06 | PHASE3 |
| NCT06785584 | NOT_YET_RECRUITING | ALK-positive Advanced NSCLC; ALK-positive Non-small Cell Lung Cancer (NSCLC); MPR; Neoadjuvant Therapy |
Fujian Medical University Union Hospital |
2025-02-01 | PHASE4 |
| NCT03213652 | ACTIVE_NOT_RECRUITING | Advanced Malignant Solid Neoplasm; Malignant Solid Neoplasm; Recurrent Ependymoma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Glioma; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Rhabdomyosarcoma; Recurrent Soft Tissue Sarcoma; Refractory Ependymoma; Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Glioma; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Primary Central Nervous System Neoplasm; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Refractory Soft Tissue Sarcoma; Wilms Tumor |
National Cancer Institute (NCI) |
2018-04-17 | PHASE2 |
| NCT03753685 | ACTIVE_NOT_RECRUITING | Nonsmall Cell Lung Cancer; Brain Metastases |
Fudan University |
2019-04-12 | PHASE2 |
| NCT05341583 | UNKNOWN | Non-small Cell Lung Cancer |
Betta Pharmaceuticals Co., Ltd. |
2022-05-24 | PHASE3 |
| NCT03155620 | ACTIVE_NOT_RECRUITING | Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Histiocytic Sarcoma; Juvenile Xanthogranuloma; Langerhans Cell Histiocytosis; Malignant Glioma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Soft Tissue Sarcoma; Refractory Ewing Sarcoma; Refractory Glioma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Primary Central Nervous System Neoplasm; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Rhabdoid Tumor; Stage III Osteosarcoma AJCC v7; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Osteosarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Stage IVA Osteosarcoma AJCC v7; Stage IVB Osteosarcoma AJCC v7; Wilms Tumor |
National Cancer Institute (NCI) |
2017-07-31 | PHASE2 |
| NCT06492525 | UNKNOWN | Healthy |
Betta Pharmaceuticals Co., Ltd. |
2024-07 | PHASE1 |
| NCT05491811 | ACTIVE_NOT_RECRUITING | Non-Small Cell Lung Cancer |
Sun Yat-sen University |
2022-08-01 | PHASE2 |
| NCT05380024 | UNKNOWN | Non Small Cell Lung Cancer |
Peking University Cancer Hospital & Institute |
2022-08-17 | PHASE2 |
| NCT05178511 | UNKNOWN | The Diagnosis Was ALK Positive NSCLC; Second Generation ALK-TKI is Resistant; Efficacy of Ensatinib in This Subset of Patients |
Li Zhang, MD |
2021-12-01 | PHASE2 |
| NCT05665283 | COMPLETED | Bioequivalency |
Xcovery Holdings, Inc. |
2022-11-29 | PHASE1 |
| NCT03574402 | UNKNOWN | Carcinoma, Non-Small-Cell Lung |
Guangdong Association of Clinical Trials |
2018-07-09 | PHASE2 |
| NCT03737994 | TERMINATED | Lung Non-Squamous Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8 |
National Cancer Institute (NCI) |
2019-07-25 | PHASE2 |
| NCT04415320 | UNKNOWN | Lung Cancer, Nonsmall Cell; Brain Metastases |
Betta Pharmaceuticals Co., Ltd. |
2019-03-21 | PHASE2 |
| NCT01625234 | COMPLETED | Advanced Solid Tumors; Non-small Cell Lung Cancer |
Xcovery Holdings, Inc. |
2012-06 | PHASE1; PHASE2 |
| NCT03215693 | UNKNOWN | Non-Small Cell Lung Cancer |
Betta Pharmaceuticals Co., Ltd. |
2017-09-28 | PHASE2 |
| NCT03608007 | UNKNOWN | Lung Cancer; ROS1 Gene Rearrangement |
Betta Pharmaceuticals Co., Ltd. |
2018-06-15 | PHASE2 |
| NCT02959619 | COMPLETED | Solid Tumor; Non-Small Cell Lung Cancer Metastatic |
Betta Pharmaceuticals Co., Ltd. |
2017-03-06 | PHASE1 |
| NCT03804541 | UNKNOWN | ALK-POSITIVE NSCLC |
Betta Pharmaceuticals Co., Ltd. |
2018-12-28 | PHASE1 |
| NCT03536481 | COMPLETED | Lung Cancer |
Betta Pharmaceuticals Co., Ltd. |
2018-06-11 | PHASE1 |
| NCT03510611 | COMPLETED | Non-Small Cell Lung Cancer |
Betta Pharmaceuticals Co., Ltd. |
2018-03-12 | PHASE1 |
| NCT02898116 | COMPLETED | Non-small Cell Lung Cancer; Carcinoma; NSCLC |
Ludwig Institute for Cancer Research |
2017-05-10 | PHASE1; PHASE2 |
(data from https://clinicaltrials.gov, updated on 2025-11-19)
Check the
Ensartinib dihydrochloride
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>).
- Ensartinib dihydrochloride Solubility in DMSO
- Ensartinib dihydrochloride Stock Solution
- Ensartinib dihydrochloride Storage
- Ensartinib dihydrochloride Stability
- Ensartinib dihydrochloride Molecular Weight
- Ensartinib dihydrochloride SMILES
- Ensartinib dihydrochloride CAS Number
- Ensartinib dihydrochloride Chemical Structure (2D and 3D)
- Ensartinib dihydrochloride SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.