{"preliminary_commentary":{"by_channel":{"youtube":9,"podcast":2,"x_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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT00446225\", \"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":"EURTAC","nct_id":"NCT00446225","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=eurtac-nct00446225. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"EURTAC","arms":[{"description":"Erlotinib (Tarceva)150 mg /day\n\nPatients will receive treatment until disease progression or unacceptable toxicity.\n\nFor all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib","label":"A","type":"EXPERIMENTAL"},{"description":"4 cycles of Chemotherapy:\n\nCisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.\n\n\\- Cisplatin plus docetaxel: cisplatin 75 mg/m2 i.v. day 1 and docetaxel 75 mg/m2 i.v.\n\nday 1. Repeat cycles every 3 weeks.\n\n\\- Cisplatin plus gemcitabine: Cisplatin 75 mg/m2 i.v. on day 1 and gemcitabine 1250 mg/m2 on days 1 and 8. Repeat cycles every 3 weeks.\n\nIn the case of patients not eligible for treatment with cisplatin, cisplatin can be replaced by carboplatin. The schedules will be the following:\n\nDocetaxel 75 mg/m2 day 1 and carboplatin AUC = 6 day 1, every 21 days.\n\nGemcitabine 1000 mg/m2 days 1 and 8 and carboplatin AUC = 5 day 1, every 21 days.\n\nPatients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.","label":"B","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2012-12","type":"ACTUAL"},"conditions":["Non-Small Cell Lung Cancer"],"enrollment":{"count":174,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Erlotinib","otherNames":["Tarceva"],"type":"DRUG"},{"name":"Carboplatin","otherNames":["Paraplatin"],"type":"DRUG"},{"name":"Gemcitabin","otherNames":["Gemzar"],"type":"DRUG"},{"name":"Docetaxel","otherNames":["Taxotere"],"type":"DRUG"},{"name":"Cisplatin","otherNames":["Platinol"],"type":"DRUG"}],"last_update":"2025-03-05","lead_sponsor":"Spanish Lung Cancer Group","official_title":"Phase III, Multicenter, Open-label, Randomized Trial of Tarceva® vs Chemotherapy in Patients With Advanced NSCLC With Mutations in the TK Domain of the EGFR","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2012-04-11","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free-survival","timeFrame":"From the date of randomization to the date of last follow up, assessed up to 24 months"}],"references":[{"citation":"Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre R, Bover I, Illiano A, Dansin E, de Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Munoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskyj A, Queralt C, de Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M, Paz-Ares L; Spanish Lung Cancer Group in collaboration with Groupe Francais de Pneumo-Cancerologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239-46. doi: 10.1016/S1470-2045(11)70393-X. Epub 2012 Jan 26.","pmid":"22285168","type":"RESULT"},{"citation":"Karachaliou N, Mayo-de las Casas C, Queralt C, de Aguirre I, Melloni B, Cardenal F, Garcia-Gomez R, Massuti B, Sanchez JM, Porta R, Ponce-Aix S, Moran T, Carcereny E, Felip E, Bover I, Insa A, Reguart N, Isla D, Vergnenegre A, de Marinis F, Gervais R, Corre R, Paz-Ares L, Morales-Espinosa D, Viteri S, Drozdowskyj A, Jordana-Ariza N, Ramirez-Serrano JL, Molina-Vila MA, Rosell R; Spanish Lung Cancer Group. Association of EGFR L858R Mutation in Circulating Free DNA With Survival in the EURTAC Trial. JAMA Oncol. 2015 May;1(2):149-57. doi: 10.1001/jamaoncol.2014.257.","pmid":"26181014","type":"DERIVED"},{"citation":"Karachaliou N, Gimenez-Capitan A, Drozdowskyj A, Viteri S, Moran T, Carcereny E, Massuti B, Vergnenegre A, de Marinis F, Molina MA, Teixido C, Rosell R. ROR1 as a novel therapeutic target for EGFR-mutant non-small-cell lung cancer patients with the EGFR T790M mutation. Transl Lung Cancer Res. 2014 Jun;3(3):122-30. doi: 10.3978/j.issn.2218-6751.2014.03.02.","pmid":"25806291","type":"DERIVED"},{"citation":"Costa C, Molina MA, Drozdowskyj A, Gimenez-Capitan A, Bertran-Alamillo J, Karachaliou N, Gervais R, Massuti B, Wei J, Moran T, Majem M, Felip E, Carcereny E, Garcia-Campelo R, Viteri S, Taron M, Ono M, Giannikopoulos P, Bivona T, Rosell R. The impact of EGFR T790M mutations and BIM mRNA expression on outcome in patients with EGFR-mutant NSCLC treated with erlotinib or chemotherapy in the randomized phase III EURTAC trial. Clin Cancer Res. 2014 Apr 1;20(7):2001-10. doi: 10.1158/1078-0432.CCR-13-2233. Epub 2014 Feb 3.","pmid":"24493829","type":"DERIVED"}],"start_date":{"date":"2007-02-15","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR","url":"https://clinicaltrials.gov/study/NCT00446225"},"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/eurtac-nct00446225"}