{"commentary":{"count":5,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":5},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"NCT05256290","nct_id":"NCT05256290","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05256290. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"* Advanced/metastatic NSCLC with acquired resistance EGFR mutation (eg, C797S), following a 3rd generation EGFR inhibitor in the 1st line setting (in the absence of concurrent T790M).\n* Advanced/metastatic NSCLC with non-classical EGFR mutation (eg, G719X) following standard-of-care therapy with an EGFR inhibitor\n* Recurrent GBM with confirmed EGFR alterations (including amplification, mutation, and/or variant)","label":"Phase 1 Dose Escalation - Monotherapy (Recruitment Closed)","type":"EXPERIMENTAL"},{"description":"Advanced/metastatic NSCLC with a non-classical driver EGFR mutation following up to 2 lines of therapy with only 1 prior EGFR targeted regimen (third-generation preferred; other approved EGFR inhibitors acceptable)","label":"Phase 2 Cohort 1: NSCLC EGFR Non-Classical Driver Mutations","type":"EXPERIMENTAL"},{"description":"Advanced/metastatic NSCLC with the acquired resistance C797S EGFR mutation following up to 2 lines of therapy, including only 1 EGFR targeted regimen, which must be a third generation EGFR TKI (eg, osimertinib)","label":"Phase 2 Cohort 2: NSCLC EGFR Acquired Resistance (C797S) Mutation","type":"EXPERIMENTAL"},{"description":"Treatment-naïve (first-line) advanced/metastatic NSCLC with a non-classical driver EGFR mutation (1 cycle of chemotherapy or immune checkpoint inhibitor are permitted). Patients with co-occurring L858R mutations and a non-classical mutation are eligible for inclusion.","label":"Phase 2 Cohort 3: Treatment Naive NSCLC EGFR Non-Classical Driver Mutations","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-12","type":"ESTIMATED"},"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"],"enrollment":{"count":200,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"silevertinib (BDTX-1535) monotherapy","type":"DRUG"}],"last_update":"2026-07-22","lead_sponsor":"Black Diamond Therapeutics, Inc.","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","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2025-11-03","type":"ACTUAL"},"primary_outcomes":[{"measure":"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)","timeFrame":"The first treatment 21-day cycle (Cycle 1)"},{"measure":"Phase 2: To assess antitumor efficacy of silevertinib (BDTX-1535)","timeFrame":"Day 1 every 2 cycles starting on Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days)"}],"references":[],"start_date":{"date":"2022-03-31","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations","url":"https://clinicaltrials.gov/study/NCT05256290"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct05256290"}