{"preliminary_commentary":{"by_channel":{"x_thread":13},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04699188\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["opnurasib (JDQ443)"],["opnurasib (JDQ443)","TNO155"],["opnurasib (JDQ443)","tislelizumab"]],"indication":"advanced KRAS G12C-mutated solid tumors","name":"KontRASt-01","nct_id":"NCT04699188","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=kontrast-01-nct04699188. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"KontRASt-01","arms":[{"description":"JDQ443","label":"Arm A","type":"EXPERIMENTAL"},{"description":"JDQ443 in combination with TNO155","label":"Arm B","type":"EXPERIMENTAL"},{"description":"JDQ443 in combination with tislelizumab","label":"Arm C","type":"EXPERIMENTAL"},{"description":"JDQ443 in combination with TNO155 and tislelizumab","label":"Arm D","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-01-25","type":"ESTIMATED"},"conditions":["KRAS G12C Mutant Solid Tumors","Carcinoma, Non-Small-Cell Lung","Carcinoma, Colorectal","Cancer of Lung","Cancer of the Lung","Lung Cancer","Neoplasms, Lung","Neoplasms, Pulmonary","Pulmonary Cancer","Pulmonary Neoplasms"],"enrollment":{"count":344,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"JDQ443","otherNames":[],"type":"DRUG"},{"name":"TNO155","otherNames":[],"type":"DRUG"},{"name":"tislelizumab","otherNames":[],"type":"BIOLOGICAL"}],"last_update":"2026-10-19","lead_sponsor":"Novartis Pharmaceuticals","official_title":"A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-01-25","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment","timeFrame":"21 days"},{"measure":"Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)","timeFrame":"24 months"},{"measure":"Dose Escalation: Frequency of dose interruptions and reductions, by treatment","timeFrame":"24 months"},{"measure":"Dose Escalation: Dose intensity by treatment","timeFrame":"24 months"},{"measure":"Dose Expansion: Overall response rate (ORR) per RECIST v1.1, by treatment","timeFrame":"24 months"},{"measure":"Dose expansion: Overall intracranial response rate (OIRR) per mRANO-BM","timeFrame":"24 months"},{"measure":"Dose expansion: Incidence and severity of AEs and SAEs","timeFrame":"24 months"},{"measure":"Dose expansion: frequency of dose interruptions and reductions, by treatment","timeFrame":"24 months"},{"measure":"Dose expansion: Dose intensity by treatment","timeFrame":"24 months"},{"measure":"Dose expansion: ORR per RECIST 1.1 of JDQ443 single agent in patients with non-small cell lung cancer (JDQ443 dose randomization group only)","timeFrame":"24 months"}],"references":[{"citation":"Lorthiois E, Gerspacher M, Beyer KS, Vaupel A, Leblanc C, Stringer R, Weiss A, Wilcken R, Guthy DA, Lingel A, Bomio-Confaglia C, Machauer R, Rigollier P, Ottl J, Arz D, Bernet P, Desjonqueres G, Dussauge S, Kazic-Legueux M, Lozac'h MA, Mura C, Sorge M, Todorov M, Warin N, Zink F, Voshol H, Zecri FJ, Sedrani RC, Ostermann N, Brachmann SM, Cotesta S. JDQ443, a Structurally Novel, Pyrazole-Based, Covalent Inhibitor of KRASG12C for the Treatment of Solid Tumors. J Med Chem. 2022 Dec 22;65(24):16173-16203. doi: 10.1021/acs.jmedchem.2c01438. Epub 2022 Nov 18.","pmid":"36399068","type":"DERIVED"}],"start_date":{"date":"2021-02-24","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation","url":"https://clinicaltrials.gov/study/NCT04699188"},"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/kontrast-01-nct04699188"}