NCT04379739

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

Neoadjuvant Camrelizumab Plus Apatinib or Platinum-based Chemotherapy for Potentially Resectable (Resectable and Initially Unresectable) II-III Non-small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Detailed Description: This is a multiple-canter, open-label, phase II trial, 2-4 cycles treatment will be planned as neo-adjuvant therapy for NSCLC participants in stage II-III. Study design: Participants: Newly diagnosed Resectable and Initially Unresectale II-III NSCLC without EGFR/ALK mutation. Treatment: Group A：camrelizumab 200 mg q3w i.v. for 2-4 cycles, platinum-based chemotherapy q3w i.v for 2-4 cycles before surgery. Group B：camrelizumab 200 mg q3w i.v. for 2-4 cycles, apatinib 250mg qd po 3w/cycle for 2-4 cycles before surgery; Endpoints: Primary objectives are to assess MPR and safety. Secondary objective is to assess 2-year overall survival (OS), disease-free survival (DFS), OS etc. Exploratory end point is to explore biomarkers.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab	camrelizumab 200mg, q3w, i.v., 2-4 cycles;

Timeline

• Start date: 2020-07-26
• Primary completion: 2022-06-29
• Completion: 2026-12-30
• First posted: 2020-05-07
• Last updated: 2023-12-06

Locations

1 site across 1 country: China