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COMPLETED
NCT04768075
PHASE3

Camrelizumab Combined With SRT/WBRT and Chemotherapy in Patients With Brain Metastases of Driven Gene-negative NSCLC

Sponsor: Guangdong Association of Clinical Trials

View on ClinicalTrials.gov

Summary

This study is a randomized, double-blind, placebo-controlled, multi-center clinical study. Target population is patients with stage IV non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of Camrelizumab + carboplatin/cisplatin + pemetrexed /paclitaxel / albumin paclitaxel ± SRT/WBRT with placebo + carboplatin/cisplatin + pemetrexed /paclitaxel / albumin paclitaxel ± SRT/WBRT. Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

Official title: Randomized, Double-blind, Placebo-controlled, Multi-center Study of Camrelizumab Combined With SRT/WBRT and Chemotherapy in Patients of NSCLC With Brain Metastases of Driven Gene-negative and Not Received Systemic Chemotherapy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2021-05-28

Completion Date

2026-04-30

Last Updated

2026-05-20

Healthy Volunteers

No

Interventions

DRUG

Camrelizumab

Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody

DRUG

Placebo

IV infusion Simulator of Camrelizumab

DRUG

Cisplatin

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Pemetrexed

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Albumin paclitaxel

IV infusion

Locations (14)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fujian, Fuzhou, China

Guangdong General Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Affiliated Hospital of Hebei University / School of Clinical Medicine

Baoding, Hebei, China

Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Binzhou Medical University Hospital

Binzhou, Shandong, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Affiliated Tumor Hospital of Guangxi Medical University

Nanning, China