Efficacy and Safety of Camrelizumab in Real-World Prospective Study

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04793139
• Other study ID #: CTONG2007
• Status: Not yet recruiting
• Start date: April 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2021
• Source: Guangdong Association of Clinical Trials
• Contact: Chongrui Xu, 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: 1000
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Camrelizumab
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials

Outcome

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