{"id":"aumolertinib-oral-tablet","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Rash"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Decreased appetite"}]},"_chembl":{"chemblId":"CHEMBL2108778","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Aumolertinib irreversibly binds to and inhibits the EGFR kinase domain, particularly effective against common activating mutations (L858R, exon 19 deletions) and the acquired T790M resistance mutation that emerges during first- or second-generation EGFR-TKI treatment. By blocking EGFR-mediated signaling, it suppresses downstream pathways driving non-small cell lung cancer cell growth and survival.","oneSentence":"Aumolertinib is a third-generation EGFR tyrosine kinase inhibitor that selectively targets EGFR mutations, including T790M resistance mutations, to inhibit tumor cell proliferation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:02:55.588Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer with EGFR T790M mutation (acquired resistance)"},{"name":"Non-small cell lung cancer with EGFR activating mutations (L858R, exon 19 deletions)"}]},"trialDetails":[{"nctId":"NCT07130916","phase":"PHASE1","title":"A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer","status":"RECRUITING","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","startDate":"2024-12-05","conditions":"Non-Small Cell Lung Cancer","enrollment":20},{"nctId":"NCT06417008","phase":"PHASE2, PHASE3","title":"A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer","status":"RECRUITING","sponsor":"Hansoh BioMedical R&D Company","startDate":"2024-05-28","conditions":"Non-Squamous Non-Small Cell Lung Cancer","enrollment":1080},{"nctId":"NCT06926413","phase":"PHASE1","title":"A Study Evaluating the Effect of Aumolertinib on the Pharmacokinetics of Midazolam in Patients With NSCLC","status":"RECRUITING","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","startDate":"2025-02-20","conditions":"Non Small Cell Lung Cancer","enrollment":20},{"nctId":"NCT06585059","phase":"PHASE1","title":"Clinical Trial of TQB2928 in Combination With a Third-Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Patients With Advanced Non-Small Cell Lung Cancers","status":"NOT_YET_RECRUITING","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","startDate":"2024-09","conditions":"Advanced Non-small Cell Lung Cancer","enrollment":20},{"nctId":"NCT05493501","phase":"PHASE3","title":"Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer","status":"TERMINATED","sponsor":"EQRx International, Inc.","startDate":"2022-12-14","conditions":"NSCLC","enrollment":8},{"nctId":"NCT06102928","phase":"NA","title":"A Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced NSCLC With EGFR 21L858R Mutation","status":"RECRUITING","sponsor":"Kunming Medical University","startDate":"2023-10-30","conditions":"Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor","enrollment":30},{"nctId":"NCT06092268","phase":"PHASE1, PHASE2","title":"A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors","status":"UNKNOWN","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","startDate":"2023-10","conditions":"Advanced Solid Tumors","enrollment":270},{"nctId":"NCT04922138","phase":"PHASE2","title":"Aumolertinib Adjuvant Therapy of Resectable Stage I EGFRm+ NSCLC With High-grade Patterns","status":"UNKNOWN","sponsor":"Baohui Han","startDate":"2022-01-14","conditions":"Lung Cancer","enrollment":104},{"nctId":"NCT05199610","phase":"PHASE1","title":"An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of EQ143","status":"COMPLETED","sponsor":"EQRx International, Inc.","startDate":"2022-03-30","conditions":"Severe Hepatic Impairment","enrollment":12},{"nctId":"NCT05800223","phase":"PHASE3","title":"Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer","status":"RECRUITING","sponsor":"Shanghai Cancer Hospital, China","startDate":"2023-01-01","conditions":"Non-small Cell Lung Cancer Metastatic","enrollment":300},{"nctId":"NCT04519983","phase":"PHASE2","title":"Efficacy of SRT as Salvage Therapy in Patients With Brain Oligo-progression of EGFR-mutant Non-small Cell Lung Cancer After Failure of the Third-generation EGFR-TKIs","status":"UNKNOWN","sponsor":"Shanghai Cancer Hospital, China","startDate":"2022-01-01","conditions":"Lung Cancer Stage IV","enrollment":40},{"nctId":"NCT02981108","phase":"PHASE1, PHASE2","title":"A Study to Evaluate Safety, PK and Efficacy of HS-10296 in Patients With NSCLC","status":"UNKNOWN","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","startDate":"2017-05-08","conditions":"Nonsmall Cell Lung Cancer","enrollment":364},{"nctId":"NCT05503888","phase":"PHASE1, PHASE2","title":"Phase Ib/II Study of Almonertinib Combined With SHR-1701 in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer","status":"NOT_YET_RECRUITING","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","startDate":"2022-10-01","conditions":"Relapsed or Advanced Non-small Cell Lung Cancer","enrollment":160},{"nctId":"NCT04969965","phase":"PHASE1","title":"To Evaluate the Comparative Pharmacokinetics of Orally Administered EQ143 in Different Racial and Ethnic Populations","status":"COMPLETED","sponsor":"EQRx, Inc.","startDate":"2021-06-21","conditions":"NSCLC, Healthy Volunteers, Pharmacokinetics","enrollment":45}],"_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":["Stereotactic Radiation Therapy"],"phase":"phase_3","status":"active","brandName":"Aumolertinib Oral Tablet","genericName":"Aumolertinib Oral Tablet","companyName":"Shanghai Cancer Hospital, China","companyId":"shanghai-cancer-hospital-china","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Aumolertinib is a third-generation EGFR tyrosine kinase inhibitor that selectively targets EGFR mutations, including T790M resistance mutations, to inhibit tumor cell proliferation. Used for Non-small cell lung cancer with EGFR T790M mutation (acquired resistance), Non-small cell lung cancer with EGFR activating mutations (L858R, exon 19 deletions).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}