Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
Non-Small Cell Lung Cancer · Advanced Non-Small Cell Squamous Lung Cancer · Metastatic Lung Non-Small Cell Carcinoma · Metastatic Lung Cancer · NSCLC · Advanced Lung Carcinoma · Epidermal Growth Factor Receptor C797S · Epidermal Growth Factor Receptor G719X · EGF-R Positive Non-Small Cell Lung Cancer · EGFR-TKI Resistant Mutation
No strong warning signs right now. The score counts warning signs; it is not a prediction.
Why this score
- +10
Main results were due Nov 2025, none posted yet
Counts until it's fixed
Score over time
- Stage
- Phase 1/2
- Patients
- 200 (planned)
- Started
- Mar 31, 2022
- Main results expected
- Nov 3, 2025
- Fully finished
- Dec 2027
- Results posted
- not yet
What counts as success
The trial's main goal(s), called the “primary outcome.”
Phase 1 Dose Escalation: To determine the maximum tolerated dose (MTD), if one exists, and the preliminary recommended Phase 2 dose(s) (RP2D[s]) of silevertinib (BDTX-1535)
Measured over: The first treatment 21-day cycle (Cycle 1)
Phase 2: To assess antitumor efficacy of silevertinib (BDTX-1535)
Measured over: Day 1 every 2 cycles starting on Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days)
Changes Tremor has spotted
Show details (technical version)
Score inputs
- results_overdue: base 10, now 10, since 2025-11-03, no fading
Raw record changes
- none yet
Trial ID NCT05256290 · record last updated 2026-07-22 · checked 2026-11-09 15:47 UTC