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NCT05256290 (BDTX1535 in advanced EGFRm-NSCLC): BVCT ex-ante prediction vs. reported outcome

On 12 May 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 23 Sep 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially TBD (OS data not available).

Clinical Trial

NCTID
NCT05256290
Drug Name
BDTX1535
Drug MoA
4th-gen CNS-penetrant EGFR masterkey inhibitor that targets classical; non-classical; and resistance EGFR mutations
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
advanced EGFRm-NSCLC
Human Patients
200
Sponsor
Black Diamond Therapeutics
Phase
Phase 1 Phase 2

Prediction of , index 1602

Prospective Prediction
Prediction Index
1602
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS with non-superior-to-osimertinib efficacy in the clinical setting of 1L EGFR-mutant NSCLC and non-superior-to-chemotherapy efficacy in the clinical setting of 2L EGFR-C797S-mutation NSCLC)
Technical Prediction
SUCCESS (statistically significant clinical benefit in ORR/PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
134 days in advance
Readout Data Interpretation
23% cORR (5/22) and 36% overall ORR (8/22); significantly better than placebo.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially TBD (OS data not available)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
200
Lead sponsor
Black Diamond Therapeutics, Inc.
Conditions
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
Interventions
DRUG: silevertinib (BDTX-1535) monotherapy
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-03-31
Primary completion
2025-11-03
Completion
2027-12
Primary outcomes
  • 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) (The first treatment 21-day cycle (Cycle 1))
  • Phase 2: To assess antitumor efficacy of silevertinib (BDTX-1535) (Day 1 every 2 cycles starting on Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days))

NCT05256290 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials