Sintilimab plus docetaxel as second-line therapy of advanced non-small cell lung cancer without targetable mutations: a phase II efficacy and biomarker study

Abstract

Highlights • Survival outcomes of patients with NSCLC without targetable mutations remain depressing. • Sintilimab plus docetaxel as second-line therapy improves progression-free survival outcomes. • Sintilimab plus docetaxel is safe and well-tolerated. • Patients detected with high PD-L1 expression in circulating tumor cells (≥32.5%, median level in 30 patients) achieved significantly higher ORR, PFS and OS. • Patients detected with PD-L1 < 1% and CD8 ≥ 1% expression from their baseline tissue samples had significantly higher ORR (p = 0.026).

Keywords

• Sintilimab plus docetaxel
• NSCLC
• CTC-PD-L1
• Multiplex immunofluorescence