NCT04372732

Serum Autoantibodies in Predicting the Efficacy of Anti-PD-1 Treatment in Patients With Advanced NSCLC

Clinical Study on the Role of New Serum Tumor Autoantibodies in Predicting the Efficacy of Anti-PD-1 Immunotherapy in Patients With Advanced Non-small Cell Lung Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

PD-1/PD-L1 blockades have attracted much attention in the treatment of lung cancer, however only a small set of patients can benefit from this kind of immunotherapy. At present, the expression level of PD-L1 is the major factor to evaluate the prognosis，, which is highly dependent on the quality of tissue samples and detection methods.Therefore, finding predictive markers,especially based on liquid biopsy, to screen the patients who will benefit most from PD-1/PD-L1 blockades is an urgent issue in immunotherapy for lung cancer. Tumor autoantibodies, as immune response products of the immune system to tumor antigens, are of great significance in tumor diagnosis. Till now, the relationship between tumor autoantibodies and immunotherapy efficacy has not been reported. In this study, 200 non-small cell lung cancer patients will be enrolled with baseline serum tumor autoantibodies detection, then treated with PD-1 blockade. The purpose of this study is to explore the correlations of serum autoantibodies expression and efficacy of PD-1 inhibitor, so that to identify new markers for predicting the efficacy of PD-1/PD-L1 immunotherapy in non-small cell lung cancer.

Conditions

• Lung Cancer
• Immunotherapy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Serum tumor autoantibody detection	All enrolled patients will be tested for ten kinds of tumor autoantibodies using peripheral blood before PD-1 bloackade treatment.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-06-01
• Completion: 2022-08-01
• First posted: 2020-05-04
• Last updated: 2020-05-04