{"preliminary_commentary":{"by_channel":{"x_thread":4},"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":false},"commentary_summary":null,"drugs_tested":[["alectinib"]],"indication":"crizotinib-resistant ALK-positive non-small cell lung cancer","name":"NP28673","nct_id":"NCT01801111","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=np28673-nct01801111. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants will receive alectinib treatment continuously starting from Day 1 Cycle 1 (in 28-day cycles) until disease progression, death, or withdrawal for any other reasons, whichever occurs first. After PD, participants without EGFR mutation will continue treatment with alectinib alone and participants with EGFR mutation will receive alectinib in combination with erlotinib as per discretion of the treating physician.","label":"Alectinib","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2017-10-27","type":"ACTUAL"},"conditions":["Non-Small-Cell Lung Carcinoma"],"enrollment":{"count":138,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Erlotinib","otherNames":["Tarceva"],"type":"DRUG"},{"name":"Alectinib","otherNames":["RO5452802"],"type":"DRUG"}],"last_update":"2018-11-02","lead_sponsor":"Hoffmann-La Roche","official_title":"An Open-Label, Non-Randomized, Multicenter Phase I/II Trial of RO5424802 Given Orally to Non-Small Cell Lung Cancer Patients Who Have ALK Mutation and Who Have Failed Crizotinib Treatment","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2014-10-24","type":"ACTUAL"},"primary_outcomes":[{"measure":"Recommended Phase 2 Dose (RP2D) of Alectinib","timeFrame":"Cycle 1 (up to 28 days)"},{"measure":"Percentage of Participants With Dose Limiting Toxicities (DLTs)","timeFrame":"Cycle 1 (up to 28 days)"},{"measure":"Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR]) as Assessed by Independent Radiological Review Committee (IRC) in Response Evaluable (RE) Population","timeFrame":"Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)"},{"measure":"Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Pretreated Participants","timeFrame":"Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)"}],"references":[{"citation":"Ou SI, Gadgeel SM, Barlesi F, Yang JC, De Petris L, Kim DW, Govindan R, Dingemans AM, Crino L, Lena H, Popat S, Ahn JS, Dansin E, Mitry E, Muller B, Bordogna W, Balas B, Morcos PN, Shaw AT. Pooled overall survival and safety data from the pivotal phase II studies (NP28673 and NP28761) of alectinib in ALK-positive non-small-cell lung cancer. Lung Cancer. 2020 Jan;139:22-27. doi: 10.1016/j.lungcan.2019.10.015. Epub 2019 Oct 14.","pmid":"31706099","type":"DERIVED"},{"citation":"Morcos PN, Nueesch E, Jaminion F, Guerini E, Hsu JC, Bordogna W, Balas B, Mercier F. Exposure-response analysis of alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer. Cancer Chemother Pharmacol. 2018 Jul;82(1):129-138. doi: 10.1007/s00280-018-3597-5. Epub 2018 May 10.","pmid":"29748847","type":"DERIVED"},{"citation":"Gadgeel SM, Shaw AT, Govindan R, Gandhi L, Socinski MA, Camidge DR, De Petris L, Kim DW, Chiappori A, Moro-Sibilot DL, Duruisseaux M, Crino L, De Pas T, Dansin E, Tessmer A, Yang JC, Han JY, Bordogna W, Golding S, Zeaiter A, Ou SI. Pooled Analysis of CNS Response to Alectinib in Two Studies of Pretreated Patients With ALK-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Dec;34(34):4079-4085. doi: 10.1200/JCO.2016.68.4639. Epub 2016 Oct 31.","pmid":"27863201","type":"DERIVED"}],"start_date":{"date":"2013-06-20","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment","url":"https://clinicaltrials.gov/study/NCT01801111"},"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/np28673-nct01801111"}