{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Zhou C"],"funding":["National Cancer Institute","NCI NIH HHS","Loxo Oncology, a wholly owned subsidiary of Eli Lilly","National Institutes of Health","NIH HHS"],"pagination":["1839-1850"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10698285"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["389(20)"],"pubmed_abstract":["<h4>Background</h4>Selpercatinib, a highly selective potent and brain-penetrant RET inhibitor, was shown to have efficacy in patients with advanced <i>RET</i> fusion-positive non-small-cell lung cancer (NSCLC) in a nonrandomized phase 1-2 study.<h4>Methods</h4>In a randomized phase 3 trial, we evaluated the efficacy and safety of first-line selpercatinib as compared with control treatment that consisted of platinum-based chemotherapy with or without pembrolizumab at the investigator's discretion. The primary end point was progression-free survival assessed by blinded independent central review in both the intention-to-treat-pembrolizumab population (i.e., patients whose physicians had planned to treat them with pembrolizumab in the event that they were assigned to the control group) and th"],"journal":["The New England journal of medicine"],"pubmed_title":["First-Line Selpercatinib or Chemotherapy and Pembrolizumab in &lt;i&gt;RET&lt;/i&gt; Fusion-Positive NSCLC."],"pmcid":["PMC10698285"],"funding_grant_id":["R25 CA233208","N/A","P30 CA008748","P30CA008748","R01 CA251591","1R01CA273224-01","R01 CA273224","1R01CA251591001A1"],"pubmed_authors":["Mavroudis D","Huang WT","Rodriguez Abreu D","Goeminne JC","Vynnychenko O","Novello S","Garrido-Lopez P","Elamin YY","Toschi L","Santini FC","Opalka P","Rieke DT","Kontakiotis T","Fernandez de Sanmamed M","Soldatenkova V","Yang JC","LIBRETTO-431 Trial Investigators","Arriola Aperribay E","Martinez Aguillo M","Solomon B","Reis T","Chu Q","Deschepper K","Moiseenko F","Kenmotsu H","Wei YF","Morabito A","Ho CL","Bernabe R","de la Mora Jimenez E","Li YC","Payakachat N","Melichar B","Kumagai T","Yanagitani N","Cicin I","Tiut C","Demir A","Cappuzzo F","Ohashi K","Sakakibara J","Harputluoglu H","Lee KY","Kowalyszyn R","Cheng Y","Loong HH","Ohe Y","Tang K","Kim DW","Gumus M","Berzoy O","Lee DH","Zhou C","Nechushtan H","Kaplan MA","Pinto GD","Nadal E","Wong M","Zhou J","Yu Y","Coves Sarto J","Ferreira C","Fan Y","Ardizzoni A","Lee SH","Ponomarova O","Rozhkova I","Han B","Reinmuth N","Ling CP","Kazantseva M","Arslan C","Lima L","Han H","Puri T","Lambrechts M","Wang CC","Hashemi S","Massuti B","Perol M","Makarycheva Y","Kadzhoian A","Dong X","Dooms C","Ciuleanu T","Vicente D","Bar J","Goto K","Hoffknecht P","de Castro Junior G","Lin AB","Wang Z","Chang GC","Rajakumar D","Leighl N","Lai CL","Park K","Sinielnikov I","Yang N","Lerzo G","Yang M","Arriola E","Cortinovis D","Dudnik J","Takeuchi S","Martinez Bueno A","Soares A","Kim JS","Alamgeer M","Schumann C","Moran Bueno MT","Matsishevska I","Ozyilkan O","Drilon A","Bondarenko I","Bria E","Han JY","Surmont V","Wislez M","Sakamoto T","Alexandru A","Insa Molla A","Baka S","Majem M","Mak MP","Siena S","Reck M","Lin CC","Zer A","Migliorino MR","Mak M","Lin SH","Mallesara G","Paz-Ares Rodriguez L","Bischoff H","Ganju V","Kobziev O","Quantin X","Biesma B","Kim YJ","Viguro M","Wolf J","Boyer M","Roubec J","Loong H","Yang CT","Liutti V","Paz G","Dingemans AMC","Syrigos K","Peled N","Dziadziuszko R","Yang TY","Goksel T","Solovyeva E","Martin C","Kato T","Demedts I","Zhang W","Lin BK","Oksuzoglu B","Levchenko E","D'Arcangelo M","De Carlo E","Hayashi H","Uh MK","Zhang Y","Alatorre Alexander J","Ortega Granados AL","Mazilu L","Aguado de la Rosa C","Chen YM","Ivashchuk O","Moro-Sibilot D","Padoan M"],"additional_accession":[]},"is_claimable":false,"name":"First-Line Selpercatinib or Chemotherapy and Pembrolizumab in &lt;i&gt;RET&lt;/i&gt; Fusion-Positive NSCLC.","description":"<h4>Background</h4>Selpercatinib, a highly selective potent and brain-penetrant RET inhibitor, was shown to have efficacy in patients with advanced <i>RET</i> fusion-positive non-small-cell lung cancer (NSCLC) in a nonrandomized phase 1-2 study.<h4>Methods</h4>In a randomized phase 3 trial, we evaluated the efficacy and safety of first-line selpercatinib as compared with control treatment that consisted of platinum-based chemotherapy with or without pembrolizumab at the investigator's discretion. The primary end point was progression-free survival assessed by blinded independent central review in both the intention-to-treat-pembrolizumab population (i.e., patients whose physicians had planned to treat them with pembrolizumab in the event that they were assigned to the control group) and th","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Nov","modification":"2026-05-29T14:14:45.648Z","creation":"2026-04-08T05:00:42.991Z"},"accession":"S-EPMC10698285","cross_references":{"pubmed":["37870973"],"doi":["10.1056/NEJMoa2309457","10.1056/nejmoa2309457"]}}