{"preliminary_commentary":{"by_channel":{"x_thread":26,"podcast":13,"youtube":7},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03802240\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["sintilimab","IBI305"],["sintilimab"]],"indication":"EGFR-mutated non-squamous NSCLC after EGFR-TKI treatment failure","name":"ORIENT-31","nct_id":"NCT03802240","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=orient-31-nct03802240. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Drug: Sintilimab 200mg IV Q3W Other Name: IBI308\n\nDrug: IBI305 15mg/kg IV Q3W\n\nDrug: Pemetrexed 500mg/m2 IV Q3W\n\nDrug: Cisplatin 75mg/m2 IV Q3W","label":"Sintilimab +IBI305+Pemetrexed+Cisplatin","type":"EXPERIMENTAL"},{"description":"Drug: Sintilimab 200mg IV Q3W Other Name: IBI308\n\nDrug: Pemetrexed 500mg/m2 IV Q3W\n\nDrug: Cisplatin 75mg/m2 IV Q3W\n\nDrug: Placebo2 Placebo2 IV Q3W","label":"Sintilimab +Placebo2+Pemetrexed+Cisplatin","type":"EXPERIMENTAL"},{"description":"Drug: Pemetrexed 500mg/m2 IV Q3W\n\nDrug: Cisplatin 75mg/m2 IV Q3W\n\nDrug: Placebo1 Placebo1 IV Q3W\n\nDrug: Placebo2 Placebo2 IV Q3W","label":"Placebo1+Placebo2+Pemetrexed+Cisplatin","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2023-06-30","type":"ACTUAL"},"conditions":["Non-Squamous Non-Small Cell Lung Cancer"],"enrollment":{"count":492,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Sintilimab","otherNames":["IBI308"],"type":"DRUG"},{"name":"IBI305","otherNames":[],"type":"DRUG"},{"name":"Pemetrexed","otherNames":[],"type":"DRUG"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"Placebo1","otherNames":[],"type":"DRUG"},{"name":"Placebo2","otherNames":[],"type":"DRUG"}],"last_update":"2023-11-27","lead_sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","official_title":"A Randomized, Double-blind, Multi-center, Phase III Clinical Study Assessing the Efficacy and Safety of Sintilimab ± IBI305 Combined With Pemetrexed and Cisplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Failed Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (ORIENT-31)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2021-07-31","type":"ACTUAL"},"primary_outcomes":[{"measure":"PFS (Progression Free Survival)","timeFrame":"Time from randomization to first documented disease progression (radiographic) assessed by Independent Imaging Assessment Committee (IRRC) or death due to any cause. up to 24month"}],"references":[{"citation":"Lu S, Wu L, Jian H, Cheng Y, Wang Q, Fang J, Wang Z, Hu Y, Han L, Sun M, Miao L, Ding C, Cui J, Wang K, Li B, Li X, Ye F, Liu A, Pan Y, Cang S, Zhou H, Sun X, Shen Y, Wang S, Zhang W, He Y. Sintilimab plus chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer with disease progression after EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): second interim analysis from a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2023 Jul;11(7):624-636. doi: 10.1016/S2213-2600(23)00135-2. Epub 2023 May 5.","pmid":"37156249","type":"DERIVED"},{"citation":"Lu S, Wu L, Jian H, Chen Y, Wang Q, Fang J, Wang Z, Hu Y, Sun M, Han L, Miao L, Ding C, Cui J, Li B, Pan Y, Li X, Ye F, Liu A, Wang K, Cang S, Zhou H, Sun X, Ferry D, Lin Y, Wang S, Zhang W, Zhang C. Sintilimab plus bevacizumab biosimilar IBI305 and chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): first interim results from a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2022 Sep;23(9):1167-1179. doi: 10.1016/S1470-2045(22)00382-5. Epub 2022 Jul 28.","pmid":"35908558","type":"DERIVED"}],"start_date":{"date":"2019-07-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure","url":"https://clinicaltrials.gov/study/NCT03802240"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/orient-31-nct03802240"}