{"preliminary_commentary":{"by_channel":{"x_thread":5,"podcast":1},"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":"PRESERVE-003","nct_id":"NCT05671510","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=preserve-003-nct05671510. 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":"PRESERVE-003","arms":[{"description":"Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.","label":"Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W","type":"EXPERIMENTAL"},{"description":"Docetaxel will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.","label":"Arm 2: Docetaxel 75 mg/m2, Q3W","type":"ACTIVE_COMPARATOR"}],"collaborators":["BioNTech SE"],"completion_date":{"date":"2028-08-31","type":"ESTIMATED"},"conditions":["Non Small Cell Lung Cancer"],"enrollment":{"count":630,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Gotistobart","otherNames":["A humanized anti-CTLA4 IgG1 monoclonal antibody","ONC-392","BNT316"],"type":"DRUG"},{"name":"Docetaxel","otherNames":["Docefrez","Taxotere"],"type":"DRUG"}],"last_update":"2026-08-13","lead_sponsor":"OncoC4, Inc.","official_title":"Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2027-08-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Overall Survival (OS)","timeFrame":"36 months"}],"references":[{"citation":"Zhang Y, Du X, Liu M, Tang F, Zhang P, Ai C, Fields JK, Sundberg EJ, Latinovic OS, Devenport M, Zheng P, Liu Y. Hijacking antibody-induced CTLA-4 lysosomal degradation for safer and more effective cancer immunotherapy. Cell Res. 2019 Aug;29(8):609-627. doi: 10.1038/s41422-019-0184-1. Epub 2019 Jul 2.","pmid":"31267017","type":"BACKGROUND"},{"citation":"Liu Y, Zheng P. Preserving the CTLA-4 Checkpoint for Safer and More Effective Cancer Immunotherapy. Trends Pharmacol Sci. 2020 Jan;41(1):4-12. doi: 10.1016/j.tips.2019.11.003. Epub 2019 Dec 10.","pmid":"31836191","type":"BACKGROUND"},{"citation":"Cho BC, Balaraman R, Chen HJ, Yu X, Fawole A, Liu ZG, Zhang J, Wu L, Yang B, Leddon JL, Hamm J, Huang Y, Wu L, Pan P, Singh P, Beardsley A, Kayali F, Davarifar A, Lee KH, Park KU, Lee Y, Li L, Wang X, Sun M, Yu Y, Jain V, Shpyro S, Wang Q, Wenger M, Sahin U, Efuni S, Song S, He K, Zheng P, Liu Y, He K, Li T, Socinski MA, Wu YL. Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial. Nat Med. 2026 Jun;32(6):2245-2253. doi: 10.1038/s41591-026-04323-8. Epub 2026 Mar 27.","pmid":"41896648","type":"RESULT"}],"start_date":{"date":"2023-06-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors","url":"https://clinicaltrials.gov/study/NCT05671510"},"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/preserve-003-nct05671510"}