{"preliminary_commentary":{"by_channel":{"x_thread":2,"podcast":1},"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":[["ceritinib"]],"indication":"ALK-positive NSCLC metastatic to brain and/or leptomeninges","name":"ASCEND-7","nct_id":"NCT02336451","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ascend-7-nct02336451. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"Ascend-7","arms":[{"description":"Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).","label":"Arm 1 (PrALKi=Y, PrBRad=Y)","type":"EXPERIMENTAL"},{"description":"Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).","label":"Arm 2 (PrALKi=Y, PrBRad=N)","type":"EXPERIMENTAL"},{"description":"Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).","label":"Arm 3 (PrALKi=N, PrBRad=Y)","type":"EXPERIMENTAL"},{"description":"Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).","label":"Arm 4 (PrALKi=N, PrBRad=N)","type":"EXPERIMENTAL"},{"description":"Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.","label":"Arm 5 (LepDis)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2019-02-06","type":"ACTUAL"},"conditions":["ALK-positive Non-small Cell Lung Cancer"],"enrollment":{"count":156,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Ceritinib","otherNames":["LDK378"],"type":"DRUG"}],"last_update":"2020-04-21","lead_sponsor":"Novartis Pharmaceuticals","official_title":"A Phase II, Multi-center, Open-label, Five-arm Study to Evaluate the Efficacy and Safety of Oral Ceritinib Treatment for Patients With ALK-positive Non-small Cell Lung Cancer (NSCLC) Metastatic to the Brain and/or to Leptomeninges","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2019-02-06","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Response Rate (ORR) Per Investigator Assessment","timeFrame":"43 months"}],"references":[{"citation":"Chow LQM, Barlesi F, Bertino EM, van den Bent MJ, Wakelee HA, Wen PY, Chiu CH, Orlov S, Chiari R, Majem M, McKeage M, Yu CJ, Garrido P, Hurtado FK, Arratia PC, Song Y, Branle F, Shi M, Kim DW. ASCEND-7: Efficacy and Safety of Ceritinib Treatment in Patients with ALK-Positive Non-Small Cell Lung Cancer Metastatic to the Brain and/or Leptomeninges. Clin Cancer Res. 2022 Jun 13;28(12):2506-2516. doi: 10.1158/1078-0432.CCR-21-1838.","pmid":"35091443","type":"DERIVED"}],"start_date":{"date":"2015-04-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges","url":"https://clinicaltrials.gov/study/NCT02336451"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/ascend-7-nct02336451"}