drugset / Trial / NCT07158489

Overcoming Resistance to Immunotherapy Combining Gemcitabine With Ivonescimab in Advanced NSCLC

NCT07158489

Phase 2 Not yet recruiting 47 enrolled Swiss Cancer Institute
NaSingle-groupOpen-labelTreatment

Summary

This Phase II clinical trial (investigates the efficacy of combining gemcitabine, a chemotherapy agent, with ivonescimab, a bispecific PD-1/VEGF antibody, in patients with advanced non-small cell lung cancer (NSCLC) who have experienced disease progression following chemoimmunotherapy (CIT). Lung cancer remains the leading cause of cancer-related death globally, and treatment options after CIT failure are limited. Gemcitabine has demonstrated immunostimulatory properties, including enhanced T-cell infiltration and reduced immunosuppressive cell populations, which may synergize with immune checkpoint inhibitors. Ivonescimab targets both PD-1 and VEGF pathways, potentially enhancing antitumor immune responses and inhibiting tumor angiogenesis. The trial aims to evaluate the objective response rate (ORR) according to RECIST v1.1 criteria. The combination therapy is expected to offer a novel and effective treatment strategy for patients with relapsed NSCLC, addressing a significant unmet medical need.

Timeline

Start
2026-07
Primary completion
2028-07
Completion
2029-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule
Subject Ivonescimab Monoclonal antibody 20 mg/kg