{"commentary":{"count":88,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":46,"podcast":22,"youtube":20},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04194944\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"LIBRETTO-431","nct_id":"NCT04194944","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=libretto-431-nct04194944. The price is fixed at order. 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":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"LIBRETTO-431","arms":[{"description":"160 milligram (mg) Selpercatinib administered orally twice daily (BID) continuously in 21-day cycles.","label":"Selpercatinib - Treatment A (TRT A)","type":"EXPERIMENTAL"},{"description":"Pemetrexed 500 milligrams per meter squared (mg/m2) administered intravenously (IV) on Day 1, every 3 weeks (Q3W), plus investigator's choice of carboplatin area under the concentration versus time curve 5 (AUC 5 \\[maximum dose of 750 mg\\] IV), or cisplatin (75 mg/m2 cisplatin IV) on Day 1 Q3W for 4 cycles, plus investigator's choice with or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.","label":"Pemetrexed and Platinum with or without Pembrolizumab - (TRT B)","type":"ACTIVE_COMPARATOR"}],"collaborators":["Loxo Oncology, Inc."],"completion_date":{"date":"2030-06","type":"ESTIMATED"},"conditions":["Non-Small Cell Lung Cancer"],"enrollment":{"count":261,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Selpercatinib","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"},{"name":"Cisplatin","type":"DRUG"},{"name":"Pemetrexed","type":"DRUG"},{"name":"Pembrolizumab","type":"DRUG"}],"last_update":"2025-10-21","lead_sponsor":"Eli Lilly and Company","official_title":"LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2023-05-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab)","timeFrame":"Baseline to Progressive Disease or Death from Any Cause Up to 31 Months"},{"measure":"PFS by BICR (With or Without Pembrolizumab)","timeFrame":"Baseline to Progressive Disease or Death from Any Cause Up to 31 Months"}],"references":[{"citation":"Duke ES, Bradford D, Sinha AK, Li X, Mishra-Kalyani PS, de Claro RA, Larkins E, Drezner N. Selpercatinib and the Crossover Conundrum: Potential Impact of Postprogression Therapies on Overall Survival. J Clin Oncol. 2026 May 20;44(15):1457-1464. doi: 10.1200/JCO-25-02375. Epub 2026 Apr 17.","pmid":"41996652","type":"DERIVED"},{"citation":"Perol M, Solomon BJ, Goto K, Park K, Nadal E, Bria E, Martin C, Bar J, Williams JN, Puri T, Li J, Uh MK, Lin BK, Zhou C. CNS Protective Effect of Selpercatinib in First-Line RET Fusion-Positive Advanced Non-Small Cell Lung Cancer. J Clin Oncol. 2024 Jul 20;42(21):2500-2505. doi: 10.1200/JCO.24.00724. Epub 2024 Jun 3.","pmid":"38828957","type":"DERIVED"},{"citation":"Zhou C, Solomon B, Loong HH, Park K, Perol M, Arriola E, Novello S, Han B, Zhou J, Ardizzoni A, Mak MP, Santini FC, Elamin YY, Drilon A, Wolf J, Payakachat N, Uh MK, Rajakumar D, Han H, Puri T, Soldatenkova V, Lin AB, Lin BK, Goto K; LIBRETTO-431 Trial Investigators. First-Line Selpercatinib or Chemotherapy and Pembrolizumab in RET Fusion-Positive NSCLC. N Engl J Med. 2023 Nov 16;389(20):1839-1850. doi: 10.1056/NEJMoa2309457. Epub 2023 Oct 21.","pmid":"37870973","type":"DERIVED"},{"citation":"Claerhout S, Lehnert S, Vander Borght S, Spans L, Dooms C, Wauters E, Vansteenkiste J, Weynand B, Deraedt K, Bourgain C, Vanden Bempt I. Targeted RNA sequencing for upfront analysis of actionable driver alterations in non-small cell lung cancer. Lung Cancer. 2022 Apr;166:242-249. doi: 10.1016/j.lungcan.2022.02.013. Epub 2022 Mar 1.","pmid":"35378489","type":"DERIVED"},{"citation":"Solomon BJ, Zhou CC, Drilon A, Park K, Wolf J, Elamin Y, Davis HM, Soldatenkova V, Sashegyi A, Lin AB, Lin BK, F Loong HH, Novello S, Arriola E, Perol M, Goto K, Santini FC. Phase III study of selpercatinib versus chemotherapy +/- pembrolizumab in untreated RET positive non-small-cell lung cancer. Future Oncol. 2021 Mar;17(7):763-773. doi: 10.2217/fon-2020-0935. Epub 2020 Nov 5.","pmid":"33150799","type":"DERIVED"}],"start_date":{"date":"2020-02-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT04194944"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/libretto-431-nct04194944"}