Drug
Ensartinib clinical trials
Also written X-396.
- studies test it
- 34
- open now
- 14
- in phase 3
- 3
- first study started
- 2012
Keep track of what changes. Save the ensartinib studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.
Watch these studiesHow studies write it
Studies that test it under each name
Studies by the year they started
34 studies that test it; most in 2025 (7)
| Year | Studies |
|---|---|
| 2012 | 1 |
| 2016 | 1 |
| 2017 | 4 |
| 2018 | 6 |
| 2019 | 3 |
| 2021 | 2 |
| 2022 | 6 |
| 2024 | 2 |
| 2025 | 7 |
| 2026 | 2 |
By phase
A phase 1/2 study counts in both.
- Phase 1
- 10
- Phase 2
- 24
- Phase 3
- 3
- Phase 4
- 1
What it is tested for
Each study’s main condition, where its own words name it.
Who runs them
Industry 12 · Other 22
Betta Pharmaceuticals Co., Ltd. (9) · National Cancer Institute (NCI) (3) · Xcovery Holdings, Inc. (3) · Sun Yat-sen University (2) · Shanghai Pulmonary Hospital, Shanghai, China (2) · Peking University Cancer Hospital & Institute (2) · M.D. Anderson Cancer Center (1) · Memorial Sloan Kettering Cancer Center (1)
Often tested with
Tested in the same studies.
Carboplatin (3) · Pemetrexed (3) · Crizotinib (3) · Bevacizumab (2) · Larotrectinib (2) · Cisplatin (2) · Erdafitinib (1) · Ivosidenib (1)
Studies
Open first, then newest update. How each study uses ensartinib is read from its arms, and is right about nine times in ten.
Testing it · 34
- Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.RecruitingPhase 2Sun Yat-sen UniversityNCT06563999Written as Ensartinib
- Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC)RecruitingPhase 1/2Tang-Du HospitalNCT07354061Written as Ensartinib + Chemotherapy
- Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors.RecruitingPhase 1/2Betta Pharmaceuticals Co., Ltd.NCT07448116Written as Ensartinib
- Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLCNot yet recruitingPhase 2Shanghai Pulmonary Hospital, Shanghai, ChinaNCT07235306Written as Ensartinib 225mg
- Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver MutationsNot yet recruitingPhase 3The First Affiliated Hospital of Guangzhou Medical UniversityNCT06955325Written as Ensartinib
- 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 StudyNot yet recruitingPhase 4Fujian Medical University Union HospitalNCT06785584Written as Ensartinib
- Neoadjuvant Ensartinib in ALK Positive Resectable Stage II to III Non-Small Cell Lung CancerNot yet recruitingPhase 2West China HospitalNCT06779539Written as Ensartinib
- Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRDNot yet recruitingPhase 2Peking University Cancer Hospital & InstituteNCT06780839Written as Ensartinib
- The Efficacy and Safety of Ensartinib As Adjuvant Therapy in Stage I ALK-positive NSCLC Patients with High Risk FactorsNot yet recruitingPhase 2Shanghai Pulmonary Hospital, Shanghai, ChinaNCT06772610Written as Ensartinib group
- Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung CancerNot yet recruitingPhase 2Nanjing First Hospital, Nanjing Medical UniversityNCT06762327Written as Ensartinib
- Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung CancerRecruitingPhase 3Betta Pharmaceuticals Co., Ltd.NCT05341583Written as Ensartinib
- A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy VolunteersNot yet recruitingPhase 1Betta Pharmaceuticals Co., Ltd.NCT06492525Written as Ensartinib
- Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung CancerRecruitingPhase 2Hebei Medical University Fourth HospitalNCT05241028Written as Ensartinib
- A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung CancerNot yet recruitingPhase 2Sichuan UniversityNCT05186506Written as Ensatinib
- Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)Active, not recruitingPhase 2National Cancer Institute (NCI)NCT03213652Written as Ensartinib
- Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung CancerActive, not recruitingPhase 1M.D. Anderson Cancer CenterNCT04837716Written as Ensartinib
- Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)Active, not recruitingPhase 2National Cancer Institute (NCI)NCT03155620Written as Ensartinib
- Treating Patients With Melanoma and ALK Alterations With EnsartinibActive, not recruitingPhase 2Memorial Sloan Kettering Cancer CenterNCT03420508Written as Ensartinib
- Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 MutationActive, not recruitingPhase 2Sun Yat-sen UniversityNCT05491811Written as Ensartinib
- Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung CancerCompletedPhase 1/2Xcovery Holdings, Inc.NCT01625234Written as Phase I: X-396 (ensartinib)
Codes
What other systems call ensartinib · ClinicalTrials.gg INT001018
- MeSH (NLM) C000629294ensartinibConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) SMA5ZS5B22ENSARTINIBConfirmed FDA, NLM, Wikidata
- Wikidata Q27896019ensartinibConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C102754EnsartinibOne source FDA
- DrugBank DB14860One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000629294 | ensartinib | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | SMA5ZS5B22 | ENSARTINIB | Confirmed FDA, NLM, Wikidata |
| Wikidata | Q27896019 | ensartinib | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C102754 | Ensartinib | One source FDA |
| DrugBank | DB14860 | — | One source Wikidata |
Also registered as ensartinib hydrochloride (UNII C2FR6VT1BQ).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.