{"commentary":{"count":758,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":528,"youtube":117,"podcast":107,"x_video":6},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04035486\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"FLAURA2","nct_id":"NCT04035486","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=flaura2-nct04035486. The price is fixed at order. We build the report after 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: 41+ commentary sources"},"registry":{"acronym":"FLAURA2","arms":[{"description":"Osimertinib (AZD9291) 80mg QD.\n\nAll patients randomized into this will only receive Osimertinib 80mg.\n\nDose may be reduced to allow for the management of IP related toxicity.","label":"Osimertinib 80mg QD","type":"ACTIVE_COMPARATOR"},{"description":"Osimertinib 80 mg in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.\n\nDose may be reduced to allow for the management of IP related toxicity.","label":"Osimertinib 80 mg QD and platinum-based chemotherapy","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-09-30","type":"ESTIMATED"},"conditions":["Non-Small Cell Lung Cancer"],"enrollment":{"count":587,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Osimertinib","type":"DRUG"},{"name":"Pemetrexed/Carboplatin","type":"DRUG"},{"name":"Pemetrexed/Cisplatin","type":"DRUG"}],"last_update":"2026-09-03","lead_sponsor":"AstraZeneca","official_title":"A Phase III, Open-label, Randomized Study of Osimertinib With or Without Platinum Plus Pemetrexed Chemo, as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA2).","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2023-04-03","type":"ACTUAL"},"primary_outcomes":[{"measure":"Adverse Events Graded by Common Terminology Criteria for Adverse Event v5 (Safety Run-In Treatment Arms Only)","timeFrame":"From first dose date to 28 days following last dose, up to 45 months"},{"measure":"Progression-free Survival (PFS) (Randomized Component)","timeFrame":"Up to approximately 33 months after the first patient is randomized (maximum follow up of 33.3 months)"},{"measure":"Sensitivity Analysis for Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment (Randomized Component)","timeFrame":"Up to approximately 33 months after the first patient is randomized (maximum follow up of 33.2 months)."}],"references":[{"citation":"Planchard D, Janne PA, Yang JC, Kobayashi K, Valdiviezo N, Fan Y, Kim TM, Galvez ML, Nishino K, Biswas B, Feng PH, Sriuranpong V, Koubkova L, Pinto GDJ, Escriu C, Tran TV, Takahashi T, Neron Y, Han JY, Figueroa A, Donachie V, Khullar A, Evans A, Albayaty M, Lee CK. Long-term safety of first-line osimertinib plus platinum-pemetrexed in EGFR-mutated advanced NSCLC: FLAURA2. Lung Cancer. 2026 Sep 14:109588. doi: 10.1016/j.lungcan.2026.109588. Online ahead of print.","pmid":"42728193","type":"DERIVED"},{"citation":"Janne PA, Planchard D, Kobayashi K, Yang JC, Liu Y, Valdiviezo N, Kim TM, Jiang L, Kagamu H, Yanagitani N, Wang J, Biswas B, Poltoratskiy A, Neron Y, Rojas C, Koubkova L, Escriu C, Ezeife DA, Mann H, Armenteros-Monterroso E, Rukazenkov Y, Lee CK; FLAURA2 Investigators. Survival with Osimertinib plus Chemotherapy in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2026 Jan 1;394(1):27-38. doi: 10.1056/NEJMoa2510308. Epub 2025 Oct 17.","pmid":"41104938","type":"DERIVED"},{"citation":"Yang J, Olabode D, Sawant-Basak A, Baldry R, Vishwanathan K, Bachina S, Todd A, Ghiorghiu D, Rukazenkov Y, Zhou D, Shahraz A. Population Pharmacokinetics and Exposure-Response Analysis of First-Line Osimertinib Plus Chemotherapy in Patients with EGFR-Mutated Advanced NSCLC. Clin Pharmacol Ther. 2025 Nov;118(5):1110-1121. doi: 10.1002/cpt.3759. Epub 2025 Jul 10.","pmid":"40637621","type":"DERIVED"},{"citation":"Murat-Onana ML, Ramalingam SS, Janne PA, Gray JE, Ahn MJ, John T, Yatabe Y, Huang X, Rukazenkov Y, Javey M, Brown H, Li-Sucholeiki X. EGFR mutation testing across the osimertinib clinical program. Lung Cancer. 2025 Jun;204:108549. doi: 10.1016/j.lungcan.2025.108549. Epub 2025 Apr 18.","pmid":"40311309","type":"DERIVED"},{"citation":"Janne PA, Planchard D, Kobayashi K, Cheng Y, Lee CK, Valdiviezo N, Laktionov K, Yang TY, Yu Y, Kato T, Jiang L, Chewaskulyong B, Lucien Geater S, Maurel JM, Rojas C, Takahashi T, Havel L, Shepherd FA, Tanaka K, Ghiorghiu D, Amin NP, Armenteros-Monterroso E, Huang X, Chaudhry AA, Yang JC. CNS Efficacy of Osimertinib With or Without Chemotherapy in Epidermal Growth Factor Receptor-Mutated Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2024 Mar 1;42(7):808-820. doi: 10.1200/JCO.23.02219. Epub 2023 Dec 2.","pmid":"38042525","type":"DERIVED"},{"citation":"Planchard D, Janne PA, Cheng Y, Yang JC, Yanagitani N, Kim SW, Sugawara S, Yu Y, Fan Y, Geater SL, Laktionov K, Lee CK, Valdiviezo N, Ahmed S, Maurel JM, Andrasina I, Goldman J, Ghiorghiu D, Rukazenkov Y, Todd A, Kobayashi K; FLAURA2 Investigators. Osimertinib with or without Chemotherapy in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2023 Nov 23;389(21):1935-1948. doi: 10.1056/NEJMoa2306434. Epub 2023 Nov 8.","pmid":"37937763","type":"DERIVED"},{"citation":"Planchard D, Feng PH, Karaseva N, Kim SW, Kim TM, Lee CK, Poltoratskiy A, Yanagitani N, Marshall R, Huang X, Howarth P, Janne PA, Kobayashi K. Osimertinib plus platinum-pemetrexed in newly diagnosed epidermal growth factor receptor mutation-positive advanced/metastatic non-small-cell lung cancer: safety run-in results from the FLAURA2 study. ESMO Open. 2021 Oct;6(5):100271. doi: 10.1016/j.esmoop.2021.100271. Epub 2021 Sep 17.","pmid":"34543864","type":"DERIVED"},{"citation":"White MN, Piotrowska Z, Stirling K, Liu SV, Banwait MK, Cunanan K, Sequist LV, Wakelee HA, Hausrath D, Neal JW. Combining Osimertinib With Chemotherapy in EGFR-Mutant NSCLC at Progression. Clin Lung Cancer. 2021 May;22(3):201-209. doi: 10.1016/j.cllc.2021.01.010. Epub 2021 Jan 27.","pmid":"33610453","type":"DERIVED"},{"citation":"Asahina H, Tanaka K, Morita S, Maemondo M, Seike M, Okamoto I, Oizumi S, Kagamu H, Takahashi K, Kikuchi T, Isobe T, Sugio K, Kobayashi K. A Phase II Study of Osimertinib Combined With Platinum Plus Pemetrexed in Patients With EGFR-Mutated Advanced Non-Small-cell Lung Cancer: The OPAL Study (NEJ032C/LOGIK1801). Clin Lung Cancer. 2021 Mar;22(2):147-151. doi: 10.1016/j.cllc.2020.09.023. Epub 2020 Oct 16.","pmid":"33199228","type":"DERIVED"}],"start_date":{"date":"2019-07-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)","url":"https://clinicaltrials.gov/study/NCT04035486"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/flaura2-nct04035486"}