Sintilimab Combined With Anlotinib in Advanced NSCLC With EGFR Uncommon Mutations

Summary

This study was a single-arm, open-label, phase II study of PD-1 monoclonal antibody combined with anlotinib in the treatment of advanced non-small cell lung cancer (NSCLC) with EGFR uncommon mutations. Twenty-one patients of NSCLC harboring rare EGFR mutations after previous treatments, including a platinum-based regimen and a targeted treatment (regardless of EGFR Ex20ins), were enrolled. Patients received sintilimab (anti-PD-1) combined with anlotinib (multi-target anti-angiogenesis). The primary endpoint was the objective response rate (ORR) based on RECIST 1.1. Secondary goals included progression-free survival (PFS), overall survival (OS), disease control rate (DCR) based on RECIST 1.1; safety Sex and tolerance. Exploratory objectives include the use of tumor tissue and plasma specimens to detect biomarkers predicting the efficacy of sidilimumab: including but not limited to tumor mutation burden (TMB), PD-L1 expression, etc.; exploring potential predictions in peripheral blood. Biomarkers for anti-group efficacy, including but not limited to TCR.

Timeline

Start

2019-08-01

Primary completion

2023-09-13

Completion

2023-09-13

Publications

• Chen K, Xu Y, Huang Z, Yu X, Hong W, Li H, Xu X, Lu H, Xie F, Chen J, Xu Y, Fan Y. Sintilimab plus anlotinib as second- or third-line therapy in metastatic non-small cell lung cancer with uncommon epidermal growth factor receptor mutations: A prospective, single-arm, phase II trial. Cancer Med. 2023 Oct;12(19):19460-19470. doi: 10.1002/cam4.6548. Epub 2023 Sep 18.

Drugs

Indications