{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":[["telaglenastat"]],"indication":"first-line metastatic KEAP1/NRF2-mutated nonsquamous NSCLC","name":"KEAPSAKE","nct_id":"NCT04265534","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keapsake-nct04265534. 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":"KEAPSAKE","arms":[{"description":"The glutaminase inhibitor telaglenastat will be administered orally, twice daily with food, every day in combination with standard-of-care pembrolizumab plus chemotherapy by intravenous (IV) infusion every 3 weeks.","label":"Telaglenastat with Pembrolizumab and Chemotherapy","type":"EXPERIMENTAL"},{"description":"Placebo will be administered orally twice daily with food every day in combination with standard-of-care pembrolizumab plus chemotherapy by IV infusion every 3 weeks.","label":"Placebo with Pembrolizumab and Chemotherapy","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2022-02-09","type":"ACTUAL"},"conditions":["Non-Small Cell Lung Cancer","Non-squamous Non-small-cell Lung Cancer","Non-Squamous Non-Small Cell Neoplasm of Lung","KEAP1 Gene Mutation","NRF2 Gene Mutation","NFE2L2 Gene Mutation"],"enrollment":{"count":40,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Telaglenastat","otherNames":["CB-839"],"type":"DRUG"},{"name":"Carboplatin Chemotherapy","otherNames":["Paraplatin"],"type":"DRUG"},{"name":"Pemetrexed Chemotherapy","otherNames":["Alimta"],"type":"DRUG"},{"name":"Pembrolizumab Immunotherapy","otherNames":["Keytruda"],"type":"BIOLOGICAL"},{"name":"Placebo","otherNames":["Oral placebo"],"type":"DRUG"},{"name":"Folic acid 400 -1000 μg","otherNames":[],"type":"DIETARY_SUPPLEMENT"},{"name":"Vitamin B12 1000 μg","otherNames":[],"type":"DIETARY_SUPPLEMENT"},{"name":"Dexamethasone 4 mg","otherNames":[],"type":"DRUG"}],"last_update":"2022-09-21","lead_sponsor":"Calithera Biosciences, Inc","official_title":"A Phase 2 Randomized, Multicenter, Double-Blind Study of the Glutaminase Inhibitor Telaglenastat With Pembrolizumab and Chemotherapy Versus Placebo With Pembrolizumab and Chemotherapy in First-Line, Metastatic KEAP1/NRF2-Mutated, Nonsquamous, Non-Small Cell Lung Cancer (NSCLC)","overall_status":"TERMINATED","phases":["PHASE2"],"primary_completion_date":{"date":"2021-11-05","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS), Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1","timeFrame":"Up to 24 months"},{"measure":"Safety and Tolerability of Telaglenastat Plus Standard-of-Care Pembrolizumab and Chemotherapy Assessed by Type, Incidence, Severity, Seriousness, and Study Drug Relatedness of Adverse Events per CTCAE v5.0","timeFrame":"Up to 55 months"},{"measure":"Recommended Phase 2 Dose of Telaglenastat in Combination with Standard-of-Care Pembrolizumab and Chemotherapy Assessed by Incidence and Nature of Protocol Defined Dose-Limiting Toxicities (DLTs) During the Safety Run-in Period","timeFrame":"Up to 6 months"}],"references":[{"citation":"Aden D, Sureka N, Zaheer S, Chaurasia JK, Zaheer S. Metabolic Reprogramming in Cancer: Implications for Immunosuppressive Microenvironment. Immunology. 2025 Jan;174(1):30-72. doi: 10.1111/imm.13871. Epub 2024 Oct 27.","pmid":"39462179","type":"DERIVED"}],"start_date":{"date":"2020-07-24","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC","url":"https://clinicaltrials.gov/study/NCT04265534"},"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/keapsake-nct04265534"}