Intrathecal sintilimab for leptomeningeal metastases of non-small cell lung cancer failed from targeted therapy and intrathecal chemotherapy (LMIS study).

ABSTRACT:

Background

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.

Methods

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).

Results

No dose-limiting toxicity was found at 1

SUBMITTER: Fan C 

PROVIDER: S-EPMC12309713 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature