{"entity":{"id":"silevertinib","kind":"drug","name":"Silevertinib","aka":["silevertinib (BDTX-1535)"],"tldr":"Silevertinib is an experimental small-molecule drug from Black Diamond Therapeutics in phase 2 trials for non-small-cell lung cancer, aimed at EGFR.","summary":"Silevertinib (BDTX-1535) is a small-molecule drug developed by Black Diamond Therapeutics. Its target is EGFR (the sponsor names EGFR). The sponsor states: A first and best-in-class 4th generation, brain-penetrant, irreversible EGFR inhibitor designed to address classical and non-classical EGFR driver and resistance mutations in NSCLC and glioblastoma. ClinicalTrials.gov describes the intervention as: Silevertinib (BDTX-1535) is a 4th generation irreversible brain penetrant EGFR MasterKey inhibitor, which targets a family of oncogenic EGFR classical and non-classical driver and resistance mutations in NSCLC. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, in non-small-cell lung cancer. The largest, NCT05256290, plans to enrol 200 participants with primary completion was scheduled for 2025-11-03 on the registry. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-2","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of Silevertinib","url":"https://clinicaltrials.gov/search?intr=BDTX-1535"},{"label":"Sponsor pipeline page","url":"https://blackdiamondtherapeutics.com/pipeline-programs/silevertinib-nsclc"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":["egfr"],"drugs":[],"companies":["black-diamond-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05256290","nct07326566"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"code":"BDTX-1535","modality":"small molecule","mechanism":"A first and best-in-class 4th generation, brain-penetrant, irreversible EGFR inhibitor designed to address classical and non-classical EGFR driver and resistance mutations in NSCLC and glioblastoma.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/silevertinib/","neighbours":{"cancer":[{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"company":[{"id":"black-diamond-therapeutics","kind":"company","name":"Black Diamond Therapeutics","route":"/companies/black-diamond-therapeutics/"}],"trial":[{"id":"nct05256290","kind":"trial","name":"Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations","route":"/trials/nct05256290/"},{"id":"nct07326566","kind":"trial","name":"Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII","route":"/trials/nct07326566/"}]}}