drugset / Trial / NCT04393883
A Study With Pembrolizumab for Non-small Cell Lung Cancer (NSCLC)
Unknown
216 enrolled
Second Affiliated Hospital, School of Medicine, Zhejiang University
Beijing Sino-Japan Friendship Hospital · collabChanghai Hospital of the Second Military Medical University · collabFirst Hospital of China Medical University · collabGuangzhou Medical University · collabJiangsu People's Hospital · collabQilu Hospital of Shandong University · collabSecond Affiliated Hospital of Third Military Medical University · collabSir Run Run Shaw Hospital · collabSouthern Medical University, China · collabThe Second Affiliated Hospital of Fujian Medical University · collabTongji Hospital · collabWest China Hospital · collabXiangya Hospital of Central South University · collabXijing Hospital Affiliated to the Fourth Military Medical University · collabZunyi Medical College · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This study is a randomized, national multicenter clinical study ，which is designed to compare the efficacy of the safety and efficacy of treatment every 3 weeks or 6 weeks in (Non-small-cell-cell cancer, NSCLC) subjects without systematic treatment， who used Pembrolizumab after 6 cycles of combined chemotherapy， estimated with stable efficacy (CR, PR, and SSD) . In this study, subjects will be randomly assigned to the following two groups according to a 1:1 ratio: (A) Standard maintenance programme group, pembrolizumab 200mg, every 3 weeks, for a total of 2 years of follow-up and follow-up for 1 year; (B) Improvement maintenance programme group, pembrolizumab 200mg, every 6 weeks, for a total of 2 years of follow-up and 1 year follow-up;
Timeline
- Start
- 2021-04-01
- Primary completion
- 2022-07-01
- Completion
- 2023-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | — |