{"id":"x-396-ensartinib","safety":{"commonSideEffects":[{"rate":"20-40%","effect":"Fatigue"},{"rate":"20-40%","effect":"Nausea"},{"rate":"10-30%","effect":"Diarrhea"},{"rate":"10-30%","effect":"Vomiting"},{"rate":"10-30%","effect":"Anemia"},{"rate":"5-20%","effect":"Thrombocytopenia"},{"rate":"5-20%","effect":"Neutropenia"},{"rate":"5-20%","effect":"Leukopenia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"ALK and ROS1 are kinases that play a role in the development and progression of certain types of cancer. Ensartinib works by blocking the activity of these kinases, which can help to slow or stop the growth of cancer cells.","oneSentence":"X-396 (ensartinib) is a potent and selective inhibitor of the anaplastic lymphoma kinase (ALK) and ROS1 kinases.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:41:11.624Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer with ALK or ROS1 rearrangements"},{"name":"Metastatic non-small cell lung cancer with ALK or ROS1 rearrangements"}]},"trialDetails":[{"nctId":"NCT03213652","phase":"PHASE2","title":"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)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2018-04-17","conditions":"Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm, Recurrent Ependymoma","enrollment":13},{"nctId":"NCT03737994","phase":"PHASE2","title":"Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2019-07-25","conditions":"Lung Non-Squamous Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8","enrollment":10},{"nctId":"NCT04837716","phase":"PHASE1","title":"Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2021-03-18","conditions":"Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IIIC Lung Cancer AJCC v8","enrollment":12},{"nctId":"NCT03155620","phase":"PHASE2","title":"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)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2017-07-31","conditions":"Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma","enrollment":1376},{"nctId":"NCT02767804","phase":"PHASE3","title":"eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Xcovery Holdings, Inc.","startDate":"2016-06","conditions":"Non-small Cell Lung Cancer","enrollment":290},{"nctId":"NCT03753685","phase":"PHASE2","title":"X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases","status":"ACTIVE_NOT_RECRUITING","sponsor":"Fudan University","startDate":"2019-04-12","conditions":"Nonsmall Cell Lung Cancer, Brain Metastases","enrollment":27},{"nctId":"NCT06563999","phase":"PHASE2","title":"Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.","status":"RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2024-11-01","conditions":"Lung Cancer Stage III, Mutation","enrollment":120},{"nctId":"NCT05341583","phase":"PHASE3","title":"Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer","status":"RECRUITING","sponsor":"Betta Pharmaceuticals Co., Ltd.","startDate":"2022-05-24","conditions":"Non-small Cell Lung Cancer","enrollment":202},{"nctId":"NCT05665283","phase":"PHASE1","title":"A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions","status":"COMPLETED","sponsor":"Xcovery Holdings, Inc.","startDate":"2022-11-29","conditions":"Bioequivalency","enrollment":32},{"nctId":"NCT05241028","phase":"PHASE2","title":"Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer","status":"RECRUITING","sponsor":"Hebei Medical University Fourth Hospital","startDate":"2022-05-01","conditions":"Non-small Cell Lung Cancer","enrollment":80},{"nctId":"NCT02959619","phase":"PHASE1","title":"Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK","status":"COMPLETED","sponsor":"Betta Pharmaceuticals Co., Ltd.","startDate":"2017-03-06","conditions":"Solid Tumor, Non-Small Cell Lung Cancer Metastatic","enrollment":48},{"nctId":"NCT03215693","phase":"PHASE2","title":"X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib","status":"UNKNOWN","sponsor":"Betta Pharmaceuticals Co., Ltd.","startDate":"2017-09-28","conditions":"Non-Small Cell Lung Cancer","enrollment":152},{"nctId":"NCT03574402","phase":"PHASE2","title":"Phase II Umbrella Study Directed by Next Generation Sequencing","status":"UNKNOWN","sponsor":"Guangdong Association of Clinical Trials","startDate":"2018-07-09","conditions":"Carcinoma, Non-Small-Cell Lung","enrollment":400},{"nctId":"NCT04146571","phase":"","title":"Expanded Access to Ensartinib for Participants With ALK+ NSCLC","status":"AVAILABLE","sponsor":"Xcovery Holdings, Inc.","startDate":"","conditions":"Non-Small Cell Lung Cancer, ALK Gene Rearrangement Positive","enrollment":""},{"nctId":"NCT02898116","phase":"PHASE1, PHASE2","title":"Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer","status":"COMPLETED","sponsor":"Ludwig Institute for Cancer Research","startDate":"2017-05-10","conditions":"Non-small Cell Lung Cancer, Carcinoma, NSCLC","enrollment":2},{"nctId":"NCT05186506","phase":"PHASE2","title":"A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer","status":"NOT_YET_RECRUITING","sponsor":"Sichuan University","startDate":"2022-01-01","conditions":"ALK Fusion Protein Expression, Adjuvant Therapy, Non-Small Cell Lung Cancer","enrollment":152},{"nctId":"NCT05178511","phase":"PHASE2","title":"Ensatinib Treat Second-generation ALK-TKI Resistance After Second-generation ALK-TKI Resistance","status":"UNKNOWN","sponsor":"Li Zhang, MD","startDate":"2021-12-01","conditions":"The Diagnosis Was ALK Positive NSCLC, Second Generation ALK-TKI is Resistant, Efficacy of Ensatinib in This Subset of Patients","enrollment":40},{"nctId":"NCT01625234","phase":"PHASE1, PHASE2","title":"Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"Xcovery Holdings, Inc.","startDate":"2012-06","conditions":"Advanced Solid Tumors, Non-small Cell Lung Cancer","enrollment":131},{"nctId":"NCT04415320","phase":"PHASE2","title":"X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases","status":"UNKNOWN","sponsor":"Betta Pharmaceuticals Co., Ltd.","startDate":"2019-03-21","conditions":"Lung Cancer, Nonsmall Cell, Brain Metastases","enrollment":37},{"nctId":"NCT03608007","phase":"PHASE2","title":"X-396 Capsule in Advanced NSCLC Patients With ROS1 Gene Rearrangement","status":"UNKNOWN","sponsor":"Betta Pharmaceuticals Co., Ltd.","startDate":"2018-06-15","conditions":"Lung Cancer, ROS1 Gene Rearrangement","enrollment":69},{"nctId":"NCT03536481","phase":"PHASE1","title":"Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers","status":"COMPLETED","sponsor":"Betta Pharmaceuticals Co., Ltd.","startDate":"2018-06-11","conditions":"Lung Cancer","enrollment":74},{"nctId":"NCT03804541","phase":"PHASE1","title":"The Absorption, Metabolism and Excretion of [14C]Ensartinib in Human","status":"UNKNOWN","sponsor":"Betta Pharmaceuticals Co., Ltd.","startDate":"2018-12-28","conditions":"ALK-POSITIVE NSCLC","enrollment":6}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"X-396 (ensartinib)","genericName":"X-396 (ensartinib)","companyName":"Xcovery Holdings, Inc.","companyId":"xcovery-holdings-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ensartinib is being studied in clinical trials for various stages of lung non-small cell carcinoma, including metastatic, recurrent, and stages IIIC, IV, and IVA. Ensartinib is being tested in combination with bevacizumab, carboplatin, and pemetrexed in these trials.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}