{"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":[["atezolizumab","erlotinib"],["atezolizumab","alectinib"]],"indication":"advanced non-small cell lung cancer","name":"NCT02013219","nct_id":"NCT02013219","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02013219. 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":"In Stage 1, starting dose of atezolizumab will be 1200 mg IV q3w administered on Day 8 of Cycle 1 and on Day 1 (21-day cycle) of each cycle thereafter along with alectinib at a starting dose of 600 mg PO BID for 28 consecutive days during Cycle 1 and on Days 1-21 of each cycle thereafter; unless maximum tolerable dose (MTD) is exceeded. The combination will be given to treatment-naive participants with ALK-positive, locally advanced or metastatic NSCLC.","label":"Stage 1: Alectinib and Atezolizumab","type":"EXPERIMENTAL"},{"description":"In Stage 1, starting dose of atezolizumab will be 1200 mg IV q3w administered on Day 8 of Cycle 1 and on Day 1 (21-day cycles) of each cycle thereafter along with erlotinib at a starting dose of 150 mg PO QD, for 28 consecutive days during Cycle 1 and on Days 1-21 of each cycle thereafter; unless MTD is exceeded. The combination will be given to participants with EGFR TKI treatment-naive, locally advanced or metastatic NSCLC.","label":"Stage 1: Erlotinib and Atezolizumab","type":"EXPERIMENTAL"},{"description":"In Stage 2, participants received the RP2D on the basis of the MTD or maximum allowed dose (MAD) of the combination treatment established in Stage 1. Treatment-naive participants with ALK-positive, locally advanced or metastatic NSCLC will be included.","label":"Stage 2: Alectinib and Atezolizumab","type":"EXPERIMENTAL"},{"description":"In Stage 2, participants received the RP2D on the basis of the MTD or MAD of the combination treatment established in Stage 1. Previously untreated (or with one prior treatment that was not an EGFR TKI), EGFR mutation positive, locally advanced or metastatic NSCLC participants will be included.","label":"Stage 2: Erlotinib and Atezolizumab","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2020-02-05","type":"ACTUAL"},"conditions":["Non-Small Cell Lung Cancer"],"enrollment":{"count":52,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Alectinib","otherNames":["Alecensa"],"type":"DRUG"},{"name":"Atezolizumab","otherNames":["TECENTRIQ","MPDL3280A"],"type":"DRUG"},{"name":"Erlotinib","otherNames":["Tarceva"],"type":"DRUG"}],"last_update":"2020-04-21","lead_sponsor":"Hoffmann-La Roche","official_title":"A Phase 1b Study of the Safety and Pharmacology of Atezolizumab (Anti-PD-L1 Antibody) Administered With Erlotinib or Alectinib in Patients With Advanced Non-Small Cell Lung Cancer","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2020-02-05","type":"ACTUAL"},"primary_outcomes":[{"measure":"Percentage of Participants with Dose-Limiting Toxicities (DLTs)","timeFrame":"28 days"},{"measure":"Recommended Phase II Dose (RP2D) of Atezolizumab and Erlotinib","timeFrame":"28 days"},{"measure":"Recommended RP2D of Atezolizumab and Alectinib","timeFrame":"28 days"}],"references":[],"start_date":{"date":"2014-04-03","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC)","url":"https://clinicaltrials.gov/study/NCT02013219"},"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/nct02013219"}