NCT04612673

A Phase II Study of Anti-PD-1 Antibody, Sintilimab, as Second-line Therapy for Biomarker-selected Advanced or Metastatic NSCLC

Anti-PD-1 Antibody, Sintilimab, as Second-line Therapy for Advanced or Metastatic Non-small Cell Lung Cancer Patients : a Phase II, Historical Control, Biomarker-selected Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to to explore the efficacy and safety of PD-1 immune check point inhibitor, sintilimab, in biomarker-selected subjects with advanced or metastatic Non-small Cell Lung Cancer who have failed from standard front-line treatment.

Detailed description

This study is planned to be carried out in The First Hospital of China Medical University. 33 cases are preliminarily expected to be included. The study started in October 2020 and ended in October 2023. It is expected that the trial will end in October 2023. In the absence of such situations as withdrawal of informed consent, intolerance of drug toxicity and side effects, or inappropriateness for further trials, each participant's expected time for research and treatment will continue until radiographically confirmed tumor progression occurs.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab	immune checkpoint inhibitor, 200mg, iv, d1,Q3W

Timeline

• Start date: 2020-11-20
• Primary completion: 2022-06-30
• Completion: 2022-12-31
• First posted: 2020-11-03
• Last updated: 2020-11-03

Locations

1 site across 1 country: China