{"preliminary_commentary":{"by_channel":{"x_thread":27,"podcast":23,"youtube":15},"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\": \"NCT02075840\", \"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":"ALEX","nct_id":"NCT02075840","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=alex-nct02075840. 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":"ALEX","arms":[{"description":"Participants will receive alectinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Alectinib","type":"EXPERIMENTAL"},{"description":"Participants will receive crizotinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Crizotinib","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2025-04-28","type":"ACTUAL"},"conditions":["Non-Small Cell Lung Cancer"],"enrollment":{"count":303,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Alectinib","otherNames":["RO5424802"],"type":"DRUG"},{"name":"Crizotinib","otherNames":[],"type":"DRUG"}],"last_update":"2026-05-29","lead_sponsor":"Hoffmann-La Roche","official_title":"Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2017-02-09","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS) by Investigator Assessment","timeFrame":"Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)"},{"measure":"Percentage of Participants With PFS Event by Investigator Assessment","timeFrame":"Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)"}],"references":[{"citation":"Sikkema BJ, Baart SJ, Paats MS, Smit EF, Schols AMWJ, Mathijssen RHJ, van Rossum EFC, Dingemans AC. Body Weight Gain Associated With Alectinib in Patients With ALK+ Non-Small Cell Lung Cancer: Pooled Analysis of Individual Patient Data From Four Prospective Clinical Trials. J Clin Oncol. 2025 Feb 20;43(6):641-650. doi: 10.1200/JCO-24-01579. Epub 2024 Dec 11.","pmid":"39661917","type":"DERIVED"},{"citation":"Dziadziuszko R, Peters S, Mok T, Camidge DR, Gadgeel SM, Ou SI, Konopa K, Noe J, Nowicka M, Bordogna W, Morcos PN, Smoljanovic V, Shaw AT. Circulating Cell-free DNA as a Prognostic Biomarker in Patients with Advanced ALK+ Non-small Cell Lung Cancer in the Global Phase III ALEX Trial. Clin Cancer Res. 2022 May 2;28(9):1800-1808. doi: 10.1158/1078-0432.CCR-21-2840.","pmid":"35275991","type":"DERIVED"},{"citation":"Mok T, Camidge DR, Gadgeel SM, Rosell R, Dziadziuszko R, Kim DW, Perol M, Ou SI, Ahn JS, Shaw AT, Bordogna W, Smoljanovic V, Hilton M, Ruf T, Noe J, Peters S. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol. 2020 Aug;31(8):1056-1064. doi: 10.1016/j.annonc.2020.04.478. Epub 2020 May 11.","pmid":"32418886","type":"DERIVED"},{"citation":"Gadgeel S, Peters S, Mok T, Shaw AT, Kim DW, Ou SI, Perol M, Wrona A, Novello S, Rosell R, Zeaiter A, Liu T, Nuesch E, Balas B, Camidge DR. Alectinib versus crizotinib in treatment-naive anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer: CNS efficacy results from the ALEX study. Ann Oncol. 2018 Nov 1;29(11):2214-2222. doi: 10.1093/annonc/mdy405.","pmid":"30215676","type":"DERIVED"},{"citation":"Burudpakdee C, Wong W, Seetasith A, Corvino FA, Yeh W, Gubens M. Economic impact of preventing brain metastases with alectinib in ALK-positive non-small cell lung cancer. Lung Cancer. 2018 May;119:103-111. doi: 10.1016/j.lungcan.2018.03.008. Epub 2018 Mar 9.","pmid":"29656744","type":"DERIVED"},{"citation":"Peters S, Camidge DR, Shaw AT, Gadgeel S, Ahn JS, Kim DW, Ou SI, Perol M, Dziadziuszko R, Rosell R, Zeaiter A, Mitry E, Golding S, Balas B, Noe J, Morcos PN, Mok T; ALEX Trial Investigators. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Aug 31;377(9):829-838. doi: 10.1056/NEJMoa1704795. Epub 2017 Jun 6.","pmid":"28586279","type":"DERIVED"},{"citation":"Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10. No abstract available.","pmid":"28501139","type":"DERIVED"}],"start_date":{"date":"2014-08-19","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants","url":"https://clinicaltrials.gov/study/NCT02075840"},"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/alex-nct02075840"}