# Silevertinib

Source: https://onco.cc/drugs/silevertinib/  
OnCo record `silevertinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-2
- Last checked: 2026-09-11
- Also known as: silevertinib (BDTX-1535)
- Tags: pipeline; ctgov-ingest
- 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.

## Sources

- ClinicalTrials.gov: trials of Silevertinib: https://clinicaltrials.gov/search?intr=BDTX-1535
- Sponsor pipeline page: https://blackdiamondtherapeutics.com/pipeline-programs/silevertinib-nsclc

## Connected records

- cancers: [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- companies: [Black Diamond Therapeutics](https://onco.cc/companies/black-diamond-therapeutics/)
- trials: [Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations](https://onco.cc/trials/nct05256290/), [Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII](https://onco.cc/trials/nct07326566/)

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