Efficacy and Safety of Camrelizumab in Real-World Study

Efficacy and Safety of Camrelizumab for Chinese NSCLC Patients: a Retrospective, 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: Unknown
• 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): 450

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Total 450 patients who have received camrelizumab with NSCLC will be enrolled. The patients should be registered consecutively in each site.

Description

Inclusion Criteria:

1. Age ≥18 years old;
2. Histopathological diagnosed confirmed non-small cell lung cancer;
3. Have received at least one camrelizumab injection between August 1, 2019 and December 31, 2020;
4. Traceable cases.

Exclusion Criteria:

1. Patients who have received other immunotherapy at the same time;
2. Patients who were participating in other intervention studies;
3. Patients with other malignant tumors;
4. The researcher believes that the patient is not suitable to participate in this study with any other conditions .

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Camrelizumab-treated advanced NSCLC; Patients with advanced non-small cell lung cancer treated with camrelizumab. Dosage form, dosage, frequency and duration of camrelizumab is determined according to the investigator's actual clinical practice.	Drug: Camrelizumab; PD-1 inhibitors; Other Names: SHR-1210

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR	Neoadjuvant therapy population: pathological complete response rate (pCR).	From August 1, 2019 to June 31, 2021
R0 resection rate.	Neoadjuvant therapy population: R0 resection rate.	From August 1, 2019 to June 31, 2021
ORR	Advanced non-small cell lung cancer: objective response rate (ORR).	From August 1, 2019 to June 31, 2021
6-month PFS%	Advanced non-small cell lung cancer: 6-month progression-free survival rate (PFS%).	From August 1, 2019 to June 31, 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MPR	Neoadjuvant population: main pathological response rate (MPR)	From August 1, 2019 to June 31, 2021
operative rate	Neoadjuvant population: operative rate	From August 1, 2019 to June 31, 2021
perioperative mortality	Neoadjuvant population: perioperative mortality	From August 1, 2019 to June 31, 2021
incidence of major postoperative complications	Neoadjuvant population: incidence of major postoperative complications (within 30 days after surgery).	From August 1, 2019 to June 31, 2021
iORR	First-line combined treatment population: median treatment cycle number, intracranial objective response rate (iORR) in patients with brain metastasis.	From August 1, 2019 to June 31, 2021
iPFS	First-line combined treatment population: median treatment cycle number, intracranial progression-free survival (iPFS) in patients with brain metastasis.	From August 1, 2019 to June 31, 2021
AE	Safety of the general population: Adverse Events (AE).	From August 1, 2019 to June 31, 2021
SAE	Safety of the general population: Serious Adverse Events (SAE).	From August 1, 2019 to June 31, 2021

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): November 30, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: October 1, 2020

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: CTONG2004

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