Efficacy and Safety of Camrelizumab in Real-World Study

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04631146
• Other study ID #: CTONG2004
• Status: Not yet recruiting
• Start date: November 30, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: October 2020
• Source: Guangdong Association of Clinical Trials
• Contact: Xu Chongrui, Doctor
• Phone: +8618696164925
• Email: xucr001[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: December 30, 2021
• Est. primary completion date: June 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• Camrelizumab
PD-1 inhibitors

Locations

Country	Name	City	State
China	Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR	Neoadjuvant therapy population: pathological complete response rate (pCR).	From August 1, 2019 to June 31, 2021
Primary	R0 resection rate.	Neoadjuvant therapy population: R0 resection rate.	From August 1, 2019 to June 31, 2021
Primary	ORR	Advanced non-small cell lung cancer: objective response rate (ORR).	From August 1, 2019 to June 31, 2021
Primary	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	MPR	Neoadjuvant population: main pathological response rate (MPR)	From August 1, 2019 to June 31, 2021
Secondary	operative rate	Neoadjuvant population: operative rate	From August 1, 2019 to June 31, 2021
Secondary	perioperative mortality	Neoadjuvant population: perioperative mortality	From August 1, 2019 to June 31, 2021
Secondary	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
Secondary	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
Secondary	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
Secondary	AE	Safety of the general population: Adverse Events (AE).	From August 1, 2019 to June 31, 2021
Secondary	SAE	Safety of the general population: Serious Adverse Events (SAE).	From August 1, 2019 to June 31, 2021