Efficacy and Safety of Camrelizumab in Real-World Prospective Study

Efficacy and Safety of Camrelizumab for Chinese NSCLC Patients: a Prospective, Observational, Multicenter Real-World Study

This observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of Chinese NSCLC patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Camrelizumab

Detailed Description

Camrelizumab is a humanized antibody for cancer immunotherapy. The National Medical Products Administration (NMPA, China) approved camrelizumab as a first-line treatment of certain patients with NSCLC. This is a multicenter non-interventional study, NSCLC patients who have been treated with camrelizumab will be included. The main objective of this study is to evaluate the efficacy and safety of camrelizumab in the clinical practice.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Chongrui Xu, Doctor; Phone Number: +8618696164925; Email: xucr001@gmail.com
• Study Contact Backup: Name: Yilong Wu, Doctor; Phone Number: 51221 +86 020 83827812; Email: syylwu@live.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Total 1000 patients who should accept camrelizumab with NSCLC will be enrolled. The patients should be registered consecutively in each site.

Description

Inclusion Criteria:

1. Sign the informed consent and volunteer to participate in the study;
2. Non-small cell lung cancer confirmed by histological/cytopathological tests;
3. Age ≥18;
4. The investigators determined that patients should receive camrelizumab alone or in combination.

Exclusion Criteria:

1. Patients who are also receiving other immunomedications or therapies;
2. Patients participating in other interventional studies;
3. Patients complicated with other malignant tumors;
4. Women who have been confirmed to be pregnant or lactating;
5. The Investigator considers the patient unsuitable for participation in any other condition of the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE,Grade 3-5	Safety of the general population:Serious Adverse Events (AE)，Grade 3-5.	From April 1, 2021 to Septeember 30, 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR	Neoadjuvant therapy population: pathological complete response rate (pCR).	From April 1, 2021 to December 30, 2024
MPR	Neoadjuvant population: main pathological response rate (MPR)	From April 1, 2021 to December 30, 2024
R0 resection rate	Neoadjuvant therapy population: R0 resection rate.	From April 1, 2021 to December 30, 2022
ORR	Advanced non-small cell lung cancer: objective response rate (ORR).	From April 1, 2021 to December 30, 2022
PFS	Advanced non-small cell lung cancer: progression-free survival.	From April 1, 2021 to December 30, 2022
OS	Advanced non-small cell lung cancer: Overall survival.	From April 1, 2021 to December 30, 2022

Collaborators and Investigators

• Sponsor: Guangdong Association of Clinical Trials
• Investigators: Principal Investigator: Yilong Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CTONG2007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No