{"preliminary_commentary":{"by_channel":{"x_thread":2,"bluesky_thread":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":"NCT04206072","nct_id":"NCT04206072","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04206072. 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":"D-0316 (75 mg or 100 mg orally, once daily), in accordance with the randomization schedule.","label":"D-0316","type":"EXPERIMENTAL"},{"description":"Icotinib (125 mg orally, three times daily), in accordance with the randomization schedule.","label":"Icotinib","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2025-07-15","type":"ACTUAL"},"conditions":["Non-Small Cell Lung Cancer","EGFR Gene Mutation"],"enrollment":{"count":362,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"D-0316 Capsule","otherNames":[],"type":"DRUG"},{"name":"Icotinib Hydrochloride Tablets","otherNames":["Conmana"],"type":"DRUG"}],"last_update":"2025-08-11","lead_sponsor":"Betta Pharmaceuticals Co., Ltd.","official_title":"A Phase II/III, Open-Label, Randomised Study to Assess the Safety and Efficacy of D-0316 Versus Icotinib as First Line Treatment in Patients With EGFR Sensitising Mutation, Locally Advanced or Metastatic NSCLC","overall_status":"COMPLETED","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2022-07-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Median Progression Free Survival (PFS) assessed by IRC","timeFrame":"From randomization to objective disease progression or death, whichever came first, assessed up to 20 months"}],"references":[{"citation":"Lu S, Zhou J, Jian H, Wu L, Cheng Y, Fan Y, Fang J, Chen G, Zhang Z, Lv D, Jiang L, Wu R, Jin X, Zhang X, Zhang J, Xie C, Sun G, Huang D, Cui J, Guo R, Han Z, Chen Z, Liang J, Zhuang W, Hu X, Zang A, Zhang Y, Cang S, Lan Y, Chen X, Liu L, Li X, Chen J, Ma R, Guo Y, Sun P, Tian P, Pan Y, Liu Z, Cao P, Ding L, Wang Y, Yuan X, Wu P. Befotertinib (D-0316) versus icotinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer: a multicentre, open-label, randomised phase 3 study. Lancet Respir Med. 2023 Oct;11(10):905-915. doi: 10.1016/S2213-2600(23)00183-2. Epub 2023 May 24.","pmid":"37244266","type":"DERIVED"},{"citation":"Lu S, Zhang Y, Zhang G, Zhou J, Cang S, Cheng Y, Wu G, Cao P, Lv D, Jian H, Chen C, Jin X, Tian P, Wang K, Jiang G, Chen G, Chen Q, Zhao H, Ding C, Guo R, Sun G, Wang B, Jiang L, Liu Z, Fang J, Yang J, Zhuang W, Liu Y, Zhang J, Pan Y, Chen J, Yu Q, Zhao M, Cui J, Li D, Yi T, Yu Z, Yang Y, Zhang Y, Zhi X, Huang Y, Wu R, Chen L, Zang A, Cao L, Li Q, Li X, Song Y, Wang D, Zhang S, Ding L, Zhang L, Yuan X, Yao L, Shen Z. Efficacy and Safety of Befotertinib (D-0316) in Patients With EGFR T790M-Mutated NSCLC That Had Progressed After Prior EGFR Tyrosine Kinase Inhibitor Therapy: A Phase 2, Multicenter, Single-Arm, Open-Label Study. J Thorac Oncol. 2022 Oct;17(10):1192-1204. doi: 10.1016/j.jtho.2022.06.002. Epub 2022 Jun 18.","pmid":"35724798","type":"DERIVED"}],"start_date":{"date":"2019-12-24","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"D-0316 Versus Icotinib in Patients With Locally Advanced or Metastatic EGFR Sensitising Mutation Positive NSCLC","url":"https://clinicaltrials.gov/study/NCT04206072"},"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/nct04206072"}