{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Fan C"],"funding":["Wu Jieping Medical Foundation","Beijing Association for Cancer Control and Prevention"],"pagination":["1559-1566"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12309713"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["27(6)"],"pubmed_abstract":["<h4>Background</h4>Leptomeningeal metastases (LMs) are serious complications of non-small cell lung cancer (NSCLC). This study aimed to investigate the safety and efficacy of intrathecal immune checkpoint inhibitors (ICIs) in treating NSCLC-LM.<h4>Methods</h4>We conducted this prospective phase 1 study (ChiCTR2200062245) using a traditional \"3+3\" design with intrathecal sintilimab (dose escalation 10, 20, 30, and 40 mg) for NSCLC-LM patients who had progressed from targeted therapy and intrathecal pemetrexed. The primary study endpoints were safety and recommended dose, and the secondary endpoints included clinical response rate, progression-free survival (PFS), intracranial progression-free survival (iPFS), and overall survival (OS).<h4>Results</h4>No dose-limiting toxicity was found at 1"],"journal":["Neuro-oncology"],"pubmed_title":["Intrathecal sintilimab for leptomeningeal metastases of non-small cell lung cancer failed from targeted therapy and intrathecal chemotherapy (LMIS study)."],"pmcid":["PMC12309713"],"funding_grant_id":["320.6750.2022-16-3","CAPTRALung2021008"],"pubmed_authors":["Huang D","Hu Y","Zhang J","Lv Y","Man S","Jiang Q","Wang G","Du Y","Li L","Teng C","Zhang Z","Xin T","Song X","Du L","Fan C","Shen W"],"additional_accession":[]},"is_claimable":false,"name":"Intrathecal sintilimab for leptomeningeal metastases of non-small cell lung cancer failed from targeted therapy and intrathecal chemotherapy (LMIS study).","description":"<h4>Background</h4>Leptomeningeal metastases (LMs) are serious complications of non-small cell lung cancer (NSCLC). This study aimed to investigate the safety and efficacy of intrathecal immune checkpoint inhibitors (ICIs) in treating NSCLC-LM.<h4>Methods</h4>We conducted this prospective phase 1 study (ChiCTR2200062245) using a traditional \"3+3\" design with intrathecal sintilimab (dose escalation 10, 20, 30, and 40 mg) for NSCLC-LM patients who had progressed from targeted therapy and intrathecal pemetrexed. The primary study endpoints were safety and recommended dose, and the secondary endpoints included clinical response rate, progression-free survival (PFS), intracranial progression-free survival (iPFS), and overall survival (OS).<h4>Results</h4>No dose-limiting toxicity was found at 1","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Jul","modification":"2026-07-14T21:27:00.555Z","creation":"2026-06-25T03:07:54.626Z"},"accession":"S-EPMC12309713","cross_references":{"pubmed":["39899029"],"doi":["10.1093/neuonc/noaf025"]}}