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Efficacy and Safety of Camrelizumab in Real-World Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04631146
Recruitment Status : Not yet recruiting
First Posted : November 17, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Guangdong Association of Clinical Trials

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

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Drug: Camrelizumab

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 Design
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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Efficacy and Safety of Camrelizumab for Chinese NSCLC Patients: a Retrospective, Observational, Multicenter Real-World Study
Estimated Study Start Date : November 30, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Drug: Camrelizumab
PD-1 inhibitors
Other Name: SHR-1210


Outcome Measures
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Primary Outcome Measures :
  1. pCR [ Time Frame: From August 1, 2019 to June 31, 2021 ]
    Neoadjuvant therapy population: pathological complete response rate (pCR).

  2. R0 resection rate. [ Time Frame: From August 1, 2019 to June 31, 2021 ]
    Neoadjuvant therapy population: R0 resection rate.

  3. ORR [ Time Frame: From August 1, 2019 to June 31, 2021 ]
    Advanced non-small cell lung cancer: objective response rate (ORR).

  4. 6-month PFS% [ Time Frame: From August 1, 2019 to June 31, 2021 ]
    Advanced non-small cell lung cancer: 6-month progression-free survival rate (PFS%).


Secondary Outcome Measures :
  1. MPR [ Time Frame: From August 1, 2019 to June 31, 2021 ]
    Neoadjuvant population: main pathological response rate (MPR)

  2. operative rate [ Time Frame: From August 1, 2019 to June 31, 2021 ]
    Neoadjuvant population: operative rate

  3. perioperative mortality [ Time Frame: From August 1, 2019 to June 31, 2021 ]
    Neoadjuvant population: perioperative mortality

  4. incidence of major postoperative complications [ Time Frame: From August 1, 2019 to June 31, 2021 ]
    Neoadjuvant population: incidence of major postoperative complications (within 30 days after surgery).

  5. iORR [ Time Frame: 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.

  6. iPFS [ Time Frame: 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.

  7. AE [ Time Frame: From August 1, 2019 to June 31, 2021 ]
    Safety of the general population: Adverse Events (AE).

  8. SAE [ Time Frame: From August 1, 2019 to June 31, 2021 ]
    Safety of the general population: Serious Adverse Events (SAE).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Total 450 patients who have received camrelizumab with NSCLC will be enrolled. The patients should be registered consecutively in each site.
Criteria

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 .
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04631146


Contacts
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Contact: Xu Chongrui, Doctor +8618696164925 xucr001@gmail.com

Locations
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China, Guangdong
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China, 510080
Contact: Chongrui Xu, MD         
Contact: Yi-Long Wu, MD    +86 20 83827812 ext 51221    syylwu@live.cn   
Principal Investigator: Yilong Wu, MD         
Sub-Investigator: Chongrui Xu, MD         
Sponsors and Collaborators
Guangdong Association of Clinical Trials
Investigators
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Principal Investigator: Wu Yilong, Doctor Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
More Information
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Responsible Party: Guangdong Association of Clinical Trials
ClinicalTrials.gov Identifier: NCT04631146    
Other Study ID Numbers: CTONG2004
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases