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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04793139
Other study ID # CTONG2007
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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