drugset / Trial / NCT06837948

Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced NSCLC

NCT06837948 ↗

Phase 2 Not yet recruiting 160 enrolled Shanghai Pulmonary Hospital, Shanghai, China
RandomizedSequentialOpen-labelTreatment

Summary

Surgical intervention remains the primary treatment option for early-stage lung cancer. With the proven efficacy of immunotherapy in the treatment of advanced non-small cell lung cancer (NSCLC), neoadjuvant immunotherapy has increasingly become a focal point of research. Blocking vascular endothelial growth factor (VEGF) not only inhibits the proliferation of vascular endothelial cells and the formation of new blood vessels but also improves the tumor microenvironment and enhances the infiltration of cytotoxic T lymphocytes within it. Simultaneously targeting the VEGF and PD-L1 pathways can create a synergistic anti-cancer effect. PM8002 injection is a bispecific antibody drug that targets both PD-L1 and VEGF, functioning as a dual-action agent that combines immune suppression and anti-angiogenesis. In patients with locally advanced stage II-III NSCLC, neoadjuvant therapy that concurrently targets PD-L1/VEGF in combination with chemotherapy can improve pathological response rates, provided that the safety of the drug combination is maintained. This approach offers additional benefits to patients, prolongs event-free survival (EFS), and improves prognosis.

Timeline

Start
2025-02-18
Primary completion
2031-12-01
Completion
2031-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject PM8002 Monoclonal antibody — —
Comparator Sintilimab Monoclonal antibody — —
Background Carboplatin Small molecule — —
Background Nab-paclitaxel Small molecule — —