{"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":[["sotorasib"]],"indication":"first-line KRAS G12C stage IV NSCLC","name":"CodeBreaK 201","nct_id":"NCT04933695","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=codebreak-201-nct04933695. 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":"CodeBreaK201","arms":[{"description":"Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express \\< 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 960 mg daily. Participants will be stratified by known presence of STK11 mutation.","label":"Sotorasib: 960 mg Daily","type":"EXPERIMENTAL"},{"description":"Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express \\< 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 240 mg daily. Participants will be stratified by known presence of STK11 mutation.","label":"Sotorasib: 240 mg Daily","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2025-05-28","type":"ACTUAL"},"conditions":["Non-small Cell Lung Cancer"],"enrollment":{"count":42,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Sotorasib","otherNames":["AMG 510","LUMYKRAS","LUMAKRAS"],"type":"DRUG"}],"last_update":"2026-07-13","lead_sponsor":"Amgen","official_title":"A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects With Stage IV NSCLC Whose Tumors Harbor a KRAS G12C Mutation in Need of First-line Treatment (CodeBreaK 201)","overall_status":"TERMINATED","phases":["PHASE2"],"primary_completion_date":{"date":"2025-05-28","type":"ACTUAL"},"primary_outcomes":[{"measure":"Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)","timeFrame":"From the first dose of trial drug until min (last dose + 30 days, end of trial [EOT]); median [min, max] duration was 5.32 [0.8, 30.9] months"}],"references":[],"start_date":{"date":"2022-01-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment","url":"https://clinicaltrials.gov/study/NCT04933695"},"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/codebreak-201-nct04933695"}