Efficacy and Safety of Camrelizumab in Real-World Prospective Study

Not yet recruiting

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT04793139
• Lead Sponsor: Guangdong Association of Clinical Trials

Brief Summary

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

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 Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-08
• Last Update Submitted: 2021-03-08
• Study First Posted: 2021-03-11
• Last Update Posted: 2021-03-11
• Study Start: 2021-04-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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