A Study With Pembrolizumab for Non-small Cell Lung Cancer (NSCLC)

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;

Conditions

• Non-small-lung-cell Cancer, NSCLC
• Pembrolizumab

Interventions

DRUG

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;

(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;

DRUG

B) Improvement maintenance programme group, pembrolizumab 200mg, every 6 weeks, for a total of 2 years of follow-up and 1 year follow-up;

(B) Improvement maintenance programme group, pembrolizumab 200mg, every 6 weeks, for a total of 2 years of follow-up and 1 year follow-up;

Sponsors & Collaborators

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Guangzhou Medical University

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• Beijing Sino-Japan Friendship Hospital

  collaborator UNKNOWN

• First Hospital of China Medical University

  collaborator OTHER

• Changhai Hospital of the Second Military Medical University

  collaborator UNKNOWN

• Jiangsu People's Hospital

  collaborator UNKNOWN

• Qilu Hospital of Shandong University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Xijing Hospital Affiliated to the Fourth Military Medical University

  collaborator UNKNOWN

• Xiangya Hospital Affiliated to Central South University

  collaborator UNKNOWN

• West China Hospital

  collaborator OTHER

• The Second Affiliated Hospital of the Army Medical University (the Third Military Medical University) - Xinqiao Hospital

  collaborator UNKNOWN

• Zunyi Medical College

  collaborator OTHER

• The Second Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Fen Lan · Fen lan， Kejin Yin, Chenzhi Zhou, Shaoxi Cai, Ting Yang, Gang Hou, Cong Bai, Mao Huang, LIang Dong,

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2022-07-01

Completion

2023-07-01

Countries

• China

Study Locations