Efficacy and Safety of Camrelizumab in Real-World Study

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Camrelizumab

• Registration Number: NCT04631146
• 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: 2020-10
• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-11-16
• Last Update Submitted: 2020-11-16
• Study First Posted: 2020-11-17
• Last Update Posted: 2020-11-17
• Study Start: 2020-11-30
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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.

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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 .

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Camrelizumab-treated advanced NSCLC	Camrelizumab	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences; 🇨🇳 Guangzhou, Guangdong, China