drugset / Trial / NCT04379739

Neoadjuvant PD-1 Antibody Plus Apatinib or Chemotherapy for Non-small Cell Lung Cancer

NCT04379739 ↗

Phase 2 Active not recruiting 89 enrolled Shanghai Pulmonary Hospital, Shanghai, China
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Immunotherapy with anti-programmed death 1 (PD-1) antibodies has revolutionized the treatment of metastatic and advanced NSCLC, but its application in neoadjuvant setting has not been well established. Results from a pilot clinical study reported the safety and feasibility of neoadjuvant PD-1 blockade. There are several neoadjuvant immunotherapy (NEOSTAR, LCMC3, NADIM, IMpower131) ongoing, and the preliminary results are reported in 2019 American Society of Clinical Oncology, which show promising therapeutic prospect. However, the therapeutic response rate (major pathologic response \[MPR\]) are not so good (20% - 45%) for PD-1 inhibitor monotherapy. To improve the therapeutic response, the investigators design a multiple-canter, open-label, phase II trial for stage II-III potentially resectable (resectable and initially unresectale) NSCLC. The participants will receive neoadjuvant PD-1 inhibitor (camrelizumab) combined with antiangiogenic drug (apatinib) or platinum-based chemotherapy.

Timeline

Start
2020-07-26
Primary completion
2022-06-29
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous
Subject Rivoceranib Small molecule 250 mg Oral