NCT04793139

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

3.2 years

First QC Date

March 8, 2021

Last Update Submit

March 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • pCR

    From April 1, 2021 to December 30, 2024

  • MPR

    From April 1, 2021 to December 30, 2024

  • R0 resection rate

    From April 1, 2021 to December 30, 2022

  • ORR

    From April 1, 2021 to December 30, 2022

  • PFS

    From April 1, 2021 to December 30, 2022

  • +1 more secondary outcomes

Interventions

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.

Also known as: SHR-1210

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Total 1000 patients who should accept camrelizumab with NSCLC will be enrolled. The patients should be registered consecutively in each site.

You may qualify if:

  • Sign the informed consent and volunteer to participate in the study;
  • Non-small cell lung cancer confirmed by histological/cytopathological tests;
  • Age ≥18;
  • The investigators determined that patients should receive camrelizumab alone or in combination.

You may not qualify if:

  • Patients who are also receiving other immunomedications or therapies;
  • Patients participating in other interventional studies;
  • Patients complicated with other malignant tumors;
  • Women who have been confirmed to be pregnant or lactating;
  • The Investigator considers the patient unsuitable for participation in any other condition of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yilong Wu

    Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chongrui Xu, Doctor

CONTACT

Yilong Wu, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

April 1, 2021

Primary Completion

June 30, 2024

Study Completion

December 30, 2024

Last Updated

March 11, 2021

Record last verified: 2021-03