{"preliminary_commentary":{"by_channel":{"x_thread":4},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"NCT06892548","nct_id":"NCT06892548","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct06892548. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming 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: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Escalating combination dose levels of BNT324 and BNT327 to define RP2D and RP2D-1 for NSCLC and SCLC.","label":"Part 1 - BNT324 + BNT327 combination therapy","type":"EXPERIMENTAL"},{"description":"In subpopulation 1 of NSCLC actionable oncogenic alteration (AGA) negative, first-line (1L)","label":"Part 2 - Cohort 1: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327","type":"EXPERIMENTAL"},{"description":"In SCLC, second-line plus (2L+)","label":"Part 2 - Cohort 2: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327","type":"EXPERIMENTAL"},{"description":"In subpopulation 1 of NSCLC AGA negative, 2L+","label":"Part 2 - Cohort 3: RP2D of BNT324 + BNT327","type":"EXPERIMENTAL"},{"description":"In subpopulation 2 of NSCLC AGA negative, 1L","label":"Part 2 - Cohort 4: RP2D of BNT324 + BNT327","type":"EXPERIMENTAL"},{"description":"In subpopulation 2 of NSCLC AGA negative, 2L+","label":"Part 2 - Cohort 5: RP2D of BNT324 + BNT327","type":"EXPERIMENTAL"},{"description":"In NSCLC AGA positive","label":"Part 2 - Cohort 6: RP2D of BNT324 + BNT327","type":"EXPERIMENTAL"},{"description":"In SCLC, 1L","label":"Part 2 - Cohort 7: RP2D of BNT324 + BNT327","type":"EXPERIMENTAL"}],"collaborators":["DualityBio Inc."],"completion_date":{"date":"2032-05","type":"ESTIMATED"},"conditions":["Advanced Lung Cancer"],"enrollment":{"count":594,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"BNT324","otherNames":["DB-1311"],"type":"BIOLOGICAL"},{"name":"BNT327","otherNames":[],"type":"BIOLOGICAL"}],"last_update":"2026-08-26","lead_sponsor":"BioNTech SE","official_title":"A Phase Ib/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Recommended Combination Dose of BNT324 With BNT327 in Participants With Advanced Lung Cancer","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2028-09","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Part 1 - Occurrence of dose limiting toxicities (DLTs) by dose level","timeFrame":"During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days]"},{"measure":"Part 1 - Occurrence of Treatment-emergent adverse events (TEAEs), serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by dose level","timeFrame":"From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first"},{"measure":"Part 1 - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs by dose level","timeFrame":"From the time of the first dose of IMP to 90 days after the last dose of IMP or until new anticancer therapy is started, whichever occurs first"},{"measure":"Part 2 cohorts 1 and 2 - Occurrence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by cohort and treatment arm","timeFrame":"From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first"},{"measure":"Part 2 cohorts 1 and 2 - Occurrence of dose interruption, reduction, and treatment discontinuation due to TEAEs by cohort and treatment arm","timeFrame":"From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first"},{"measure":"Part 2 cohorts 1 and 2 - Objective response rate (ORR) by cohort and treatment arm","timeFrame":"From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months"},{"measure":"Part 2 cohorts 3-7 - ORR by cohort","timeFrame":"From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months"}],"references":[],"start_date":{"date":"2025-05-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer","url":"https://clinicaltrials.gov/study/NCT06892548"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct06892548"}