{"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":"NCT05099172","nct_id":"NCT05099172","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05099172. 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":"Doses of BAY2927088 will be increased in a stepwise fashion up to the MTD or MAD.","label":"Dose escalation","type":"EXPERIMENTAL"},{"description":"Dose Escalation and Backfill run concurrently","label":"Backfill","type":"EXPERIMENTAL"},{"description":"Eight independent groups (group A, B1, B2, C, D, E, F, G, H) are planned. Dose Expansion may start at a dose level that has been evaluated in Escalation/Backfill in at least 9 participants and considered safe or at any other dose levels that are below the highest dose level that is considered safe.","label":"Dose expansion","type":"EXPERIMENTAL"},{"description":"Initiation of the Extension part will depend on the benefit-risk profile observed during Dose Expansion. Additionally, enrollment may be prematurely terminated based on emerging data at the discretion of the Sponsor.","label":"Extension part","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2031-06-30","type":"ESTIMATED"},"conditions":["Advanced Non-small Cell Lung Cancer","EGFR Mutation","HER2 Mutation"],"enrollment":{"count":400,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"BAY2927088_formulation A","type":"DRUG"},{"name":"BAY2927088_formulation B_1","type":"DRUG"},{"name":"BAY2927088_formulation B_2","type":"DRUG"},{"name":"BAY2927088_formulation B_3","type":"DRUG"}],"last_update":"2026-08-12","lead_sponsor":"Bayer","official_title":"An Open Label, First-in-human Study of BAY 2927088 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring an EGFR and/or HER2 Mutation","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2026-03-16","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of participants with treatment-emergent adverse events (TEAEs)","timeFrame":"Up to 30 days after the last administration of study treatment"},{"measure":"Number of participants with treatment-emergent serious adverse events (TESAEs)","timeFrame":"Up to 30 days after the last administration of study treatment"},{"measure":"Severity of TEAEs","timeFrame":"Up to 30 days after the last administration of study treatment"},{"measure":"Severity of TESAEs","timeFrame":"Up to 30 days after the last administration of study treatment"},{"measure":"Number of participants who discontinue study treatment due to an AE","timeFrame":"About 4 years (Up to the end of study treatment)"},{"measure":"Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2927088 within the DLT observation period in Dose Escalation (including participants from Backfill qualifying for the MTD population)","timeFrame":"At the end of Cycle 1 of a 21-day cycle"},{"measure":"Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level associated with administration of BAY2927088 in the DLT observation period in Dose Escalation (including participants from Backfill)","timeFrame":"At the end of Cycle 1 of a 21-day cycle"},{"measure":"Cmax of BAY2927088","timeFrame":"Cycle 1, Day 1 (Cycle duration is 21 days)"},{"measure":"AUC(0-24) of BAY2927088 for QD","timeFrame":"Cycle 1, Day 1 (Cycle duration is 21 days)"},{"measure":"AUC(0-12) of BAY2927088 for BID","timeFrame":"Cycle 1, Day 1 (Cycle duration is 21 days)"},{"measure":"Cmax,md of BAY2927088","timeFrame":"Cycle 1, Day 15 (Cycle duration is 21 days)"},{"measure":"AUC(0-24)md of BAY2927088 for QD","timeFrame":"Cycle 1, Day 15 (Cycle duration is 21 days)"},{"measure":"AUC(0-12)md of BAY2927088 for BID","timeFrame":"Cycle 1, Day 15 (Cycle duration is 21 days)"},{"measure":"Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by blinded independent central review (BICR) in extension part","timeFrame":"From the start of the study treatment up to 12 months"}],"references":[{"citation":"Le X, Kim TM, Loong HH, Prelaj A, Goh BC, Li L, Fang Y, Lu S, Dong X, Wu L, Shinno Y, Daniele G, Yang TY, Kim HR, Ruiter G, Zhao J, Novello S, Miao L, Janne PA, Goto K, Ruttinger D, Descamps T, Brase JC, Bao W, Li R, Brega N, Grassi P, Girard N, Tan DS; SOHO-01 Investigators. Sevabertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2025 Nov 6;393(18):1819-1832. doi: 10.1056/NEJMoa2511065. Epub 2025 Oct 17.","pmid":"41104928","type":"DERIVED"}],"start_date":{"date":"2021-10-25","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)","url":"https://clinicaltrials.gov/study/NCT05099172"},"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/nct05099172"}