9 unknown, 7 not yet recruiting, 6 active not recruiting, 6 completed. 22 Phase 2, 11 Phase 1, 3 Phase 3, 1 Phase 4.
Follow ensartinib: new trials by email Literature Review of ensartinib trials Research Report on ensartinib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC) Ensartinib + Chemotherapy - NSCLC (Non-small Cell Lung Cancer) | Phase 1 / Phase 2 | Recruiting | Tang-Du Hospital | 20 | 2026-03-25 | 2026-04-01 |
| Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors. MCLA-129, Ensartinib - Solid Advanced Tumor | Phase 1 / Phase 2 | Recruiting | Betta Pharmaceuticals Co., Ltd. | 164 | 2026-01-31 | 2026-03-04 |
| Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC Ensartinib 225mg, Placebo Ensartinib 225mg - NSCLC Stage III, Ensartinib | Phase 2 | Not yet recruiting | Shanghai Pulmonary Hospital, Shanghai, China | 45 | 2025-12-01 | 2025-11-19 |
| Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations Icotinib, Rezivertinib, Ensartinib - Non-Small Cell Lung Cancer | Phase 3 | Not yet recruiting | The First Affiliated Hospital of Guangzhou Medical University | 270 | 2025-05-01 | 2025-05-06 |
| Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer Ensartinib - Solid Tumors | Phase 2 | Not yet recruiting | Nanjing First Hospital, Nanjing Medical University | 20 | 2025-02-28 | 2025-01-07 |
| Efficacy and Safety of Ensartinib in Neoadjuvant Therapy for Stage IIA - IIIB (Operable or Potentially Operable) ALK-Positive Lung Adenocarcinoma ：A Multicenter, Real-World Clinical Study Ensartinib - ALK-positive Advanced NSCLC, ALK-positive Non-small Cell Lung Cancer (NSCLC) | Phase 4 | Not yet recruiting | Fujian Medical University Union Hospital | 30 | 2025-02-01 | 2025-01-21 |
| Neoadjuvant Ensartinib in ALK Positive Resectable Stage II to III Non-Small Cell Lung Cancer Ensartinib - Non-Small Cell Lung Cancer | Phase 2 | Not yet recruiting | West China Hospital | 33 | 2025-01-15 | 2025-01-17 |
| Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD Ensartinib - NSCLC, Stage I, II, IIIA, IIIB | Phase 2 | Not yet recruiting | Peking University Cancer Hospital & Institute | 70 | 2025-01-15 | 2025-01-17 |
| Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations. Sunvozertinib, Crizotinib, Pralsetinib - Lung Cancer Stage III, Mutation | Phase 2 | Recruiting | Sun Yat-sen University | 120 | 2024-11-01 | 2026-04-21 |
| A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers Ensartinib, Rifampicin, Itraconazole - Healthy | Phase 1 | Unknown | Betta Pharmaceuticals Co., Ltd. | 36 | 2024-07-01 | 2024-07-09 |
| A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions Ensartinib Hydrochloride - Bioequivalency | Phase 1 | Completed | Xcovery Holdings, Inc. | 32 | 2022-11-29 | 2024-02-20 |
| A Study of Ensartinib as Neoadjuvant Therapy for Patients With ALK Positive Resectable Non-Small Cell Lung Cancer Ensartinib - Non Small Cell Lung Cancer | Phase 2 | Unknown | Peking University Cancer Hospital & Institute | 10 | 2022-08-17 | 2022-08-18 |
| Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation Ensartinib, Bevacizumab - Non-Small Cell Lung Cancer | Phase 2 | Active not recruiting | Sun Yat-sen University | 47 | 2022-08-01 | 2026-05-04 |
| Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer Ensartinib, Placebo - Non-small Cell Lung Cancer | Phase 3 | Unknown | Betta Pharmaceuticals Co., Ltd. | 202 | 2022-05-24 | 2024-08-23 |
| A Real World Study of Ensartinib in Advanced ALK-positive NSCLC Ensartinib - Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase I1171N | Recruiting | Peking Union Medical College Hospital | 490 | 2022-05-13 | 2022-08-11 | |
| Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer Ensartinib - Non-small Cell Lung Cancer | Phase 2 | Recruiting | Hebei Medical University Fourth Hospital | 80 | 2022-05-01 | 2023-10-10 |
| A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer Ensatinib, chemotherapy - ALK Fusion Protein Expression, Adjuvant Therapy | Phase 2 | Not yet recruiting | Sichuan University | 152 | 2022-01-01 | 2022-01-11 |
| Ensatinib Treat Second-generation ALK-TKI Resistance After Second-generation ALK-TKI Resistance Ensartinib - The Diagnosis Was ALK Positive NSCLC, Second Generation ALK-TKI is Resistant | Phase 2 | Unknown | Li Zhang, MD | 40 | 2021-12-01 | 2022-01-05 |
| Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer Bevacizumab, Carboplatin, Ensartinib - Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma | Phase 1 | Active not recruiting | M.D. Anderson Cancer Center | 12 | 2021-03-18 | 2026-08-11 |
| Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer Alectinib, Brigatinib, Carboplatin - Lung Non-Squamous Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8 | Phase 2 | Terminated | National Cancer Institute (NCI) | 10 | 2019-07-25 | 2026-04-23 |
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Carcinoma, Non-Small-Cell Lung (21) · Lung Neoplasms (5) · Carcinoma (2) · Central Nervous System Neoplasms (2) · Ependymoma (2) · Glioma (2) · Hepatoblastoma (2) · Histiocytosis, Langerhans-Cell (2) · Lymphoma, Non-Hodgkin (2) · Medulloblastoma (2) · Neuroblastoma (2) · Neuroectodermal Tumors, Primitive, Peripheral (2) · Osteosarcoma (2) · Rhabdoid Tumor (2) · Rhabdomyosarcoma (2)
Betta Pharmaceuticals Co., Ltd. (10) · Xcovery Holdings, Inc. (4) · National Cancer Institute (NCI) (3) · Peking University Cancer Hospital & Institute (2) · Sun Yat-sen University (2) · Fujian Medical University Union Hospital (1) · Guangdong Association of Clinical Trials (1) · Hebei Medical University Fourth Hospital (1) · Li Zhang, MD (1) · Ludwig Institute for Cancer Research (1) · M.D. Anderson Cancer Center (1) · Memorial Sloan Kettering Cancer Center (1) · Nanjing First Hospital, Nanjing Medical University (1) · Peking Union Medical College Hospital (1) · Shanghai Pulmonary Hospital, Shanghai, China (1)
China (21) · United States (10) · Australia (3) · Canada (3) · Puerto Rico (2) · Argentina (1) · Belgium (1) · Brazil (1) · Czechia (1) · France (1) · Germany (1) · Hong Kong (1) · Israel (1) · Italy (1) · Netherlands (1)
Giovanni Selvaggi, MD (2) · Li Zhang, MD (2) · Alexander Shoushtari (1) · Donald W Parsons (1) · Feng Shao (1) · Jessica J Lin (1) · Leena Gandhi, MD, PhD (1) · Meijuan Huang, MD (1) · Meredith S Irwin (1) · Shun Lu (1) · Si-Yu Wang, MD (1) · Tongyu Zhu (1) · Yasir Y Elamin, MD (1) · Yi-Long Wu (1) · You Lu, MD (1)
PMID 29563138, PMID 31628085, PMID 33044566, PMID 33591402, PMID 34473194, PMID 34486544, PMID 35353553, PMID 35659479, PMID 36647478, PMID 37488286, PMID 41166674, PMID 42418775, PMID 42686334
U10CA180886 (2), U10CA180868 (1)