{"preliminary_commentary":{"by_channel":{"podcast":53,"youtube":50,"x_thread":22},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03950674\", \"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."},"name":"KEYNOTE-189","nct_id":"NCT03950674","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-189-nct03950674. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants receive pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\\^2 IV Q3W until progression. Participants who receive pembrolizumab 200 mg IV Q3W for up to 2 years, but experience disease progression, are eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.","label":"Pembrolizumab with Pemetrexed and Platinum Chemotherapy Followed by Pembrolizumab and Pemetrexed","type":"EXPERIMENTAL"},{"description":"Participants receive saline placebo IV PLUS pemetrexed 500 mg/m\\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\\^2 IV Q3W until progression. Participants who receive saline placebo, but experience disease progression, can switch over to pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 2 years. The participants who switch over to pembrolizumab 200 mg IV Q3W, but experience disease progression, are eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.","label":"Placebo with Pemetrexed and Platinum Chemotherapy Followed by Placebo and Pemetrexed","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2023-06-22","type":"ACTUAL"},"conditions":["Non-Small-Cell Lung Carcinoma"],"enrollment":{"count":40,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab 200 mg","otherNames":[],"type":"BIOLOGICAL"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"},{"name":"Pemetrexed","otherNames":[],"type":"DRUG"},{"name":"Folic acid 350-1000 μg","otherNames":[],"type":"DIETARY_SUPPLEMENT"},{"name":"Vitamin B12 1000 μg","otherNames":[],"type":"DIETARY_SUPPLEMENT"},{"name":"Dexamethasone 4 mg","otherNames":[],"type":"DRUG"},{"name":"Saline solution","otherNames":[],"type":"DRUG"}],"last_update":"2024-06-10","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2019-05-20","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging","timeFrame":"Up to approximately 31 months"},{"measure":"Overall Survival (OS)","timeFrame":"Up to approximately 31 months"}],"references":[{"citation":"Horinouchi H, Nogami N, Saka H, Nishio M, Tokito T, Takahashi T, Kasahara K, Hattori Y, Ichihara E, Adachi N, Noguchi K, Souza F, Kurata T. Pembrolizumab plus pemetrexed-platinum for metastatic nonsquamous non-small-cell lung cancer: KEYNOTE-189 Japan Study. Cancer Sci. 2021 Aug;112(8):3255-3265. doi: 10.1111/cas.14980. Epub 2021 Jun 15.","pmid":"34036692","type":"RESULT"},{"citation":"Gadgeel SM, Rodriguez-Abreu D, Halmos B, Garassino MC, Kurata T, Cheng Y, Jensen E, Shamoun M, Rajagopalan K, Paz-Ares L. Pembrolizumab Plus Chemotherapy for Metastatic NSCLC With Programmed Cell Death Ligand 1 Tumor Proportion Score Less Than 1%: Pooled Analysis of Outcomes After Five Years of Follow-Up. J Thorac Oncol. 2024 Aug;19(8):1228-1241. doi: 10.1016/j.jtho.2024.04.011. Epub 2024 Apr 18.","pmid":"38642841","type":"DERIVED"},{"citation":"Cheng Y, Yang JC, Okamoto I, Zhang L, Hu J, Wang D, Hu C, Zhou J, Wu L, Cao L, Liu J, Zhang H, Sun H, Wang Z, Gao H, Yan Y, Xiao S, Lin J, Pietanza MC, Kurata T. Pembrolizumab plus chemotherapy for advanced non-small-cell lung cancer without tumor PD-L1 expression in Asia. Immunotherapy. 2023 Sep;15(13):1029-1044. doi: 10.2217/imt-2023-0043. Epub 2023 Jul 19.","pmid":"37465924","type":"DERIVED"},{"citation":"Rolfo C, Hess LM, Jen MH, Peterson P, Li X, Liu H, Lai Y, Sugihara T, Kiiskinen U, Vickers A, Summers Y. External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer. ESMO Open. 2022 Aug;7(4):100551. doi: 10.1016/j.esmoop.2022.100551. Epub 2022 Aug 2.","pmid":"35930972","type":"DERIVED"}],"start_date":{"date":"2016-02-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)-Japan Extension Study","url":"https://clinicaltrials.gov/study/NCT03950674"},"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/keynote-189-nct03950674"}