Phase 3Recruiting
Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Combined With Monoclonal Antibody in Locally Advanced NSCLC
Neoadjuvant Chemotherapy Combined With PD-L1/VEGF Bispecific Antibody Versus Combined With PD-1 Monoclonal Antibody in Locally Advanced Non-Small Cell Lung Cancer: A Multicenter, Randomized Controlled Clinical Trial
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China (Academic or other)
- Enrolment
- 290 planned
- Conditions
- Locally Advanced Non-Small Cell Lung Cancer
- Interventions
- PD-L1/VEGF Bispecific Antibody; PD-1 Monoclonal Antibody; Nab-paclitaxel; Carboplatin; Surgery
- Ages
- adults, older adults
- Registry
- NCT07863999
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Pathologic complete response (PCR) rate
History
Primary completion expected
Registered
Started