{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":false},"name":"NCT04479306","nct_id":"NCT04479306","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04479306. The price is quoted from the commentary indexed so far and fixed at order. Final coverage is set when the report is built. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified HCP statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive osimertinib PO QD on days 1-28 and alisertib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease may crossover to Arm B.","label":"Arm A (osimertinib, alisertib)","type":"EXPERIMENTAL"},{"description":"Patients receive osimertinib PO QD on days 1-28 and sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease may crossover to Arm A.","label":"Arm B (osimertinib, sapanisertib)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-07-27","type":"ACTUAL"},"conditions":["Recurrent Lung Non-Small Cell Carcinoma","Stage IIIB Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVB Lung Cancer AJCC v8"],"enrollment":{"count":37,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Alisertib","type":"DRUG"},{"name":"Osimertinib","type":"DRUG"},{"name":"Sapanisertib","type":"DRUG"}],"last_update":"2026-04-16","lead_sponsor":"M.D. Anderson Cancer Center","official_title":"A Ph1b Study of Osimertinib + Alisertib or Sapanisertib for Osimertinib-Resistant EGFR Mutant Non-Small Cell Lung Cancer (NSCLC) (Crossover Study)","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2023-07-27","type":"ACTUAL"},"primary_outcomes":[{"measure":"Recommended phase 2 dose (RP2D) of osimertinib and alisertib combination (Arm A)","timeFrame":"Up to 30 days after the last dose"},{"measure":"RP2D of osimertinib and sapanisertib combination (Arm B)","timeFrame":"Up to 30 days"},{"measure":"Dose-limiting toxicity (DLT)","timeFrame":"During cycle 1 (28 days)"},{"measure":"Incidence of adverse events","timeFrame":"Up to 30 days after the last dose"}],"references":[],"start_date":{"date":"2020-06-18","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Osimertinib in Combination With Alisertib or Sapanisertib for the Treatment of Osimertinib-Resistant EGFR Mutant Stage IIIB or IV Non-Small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT04479306"},"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/nct04479306"}