Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer (NSCLC)

September 19, 2022 updated by: Henan Cancer Hospital
To explore the effectiveness and safety of Camrelizumab based cross-line therapy for patients with advanced NSCLC in the real world

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with stage IIIb, IV, or relapsed non-small cell lung cancer diagnosed cytologically or histopathologically as EGFR/ALK-

Description

Inclusion Criteria:

  1. Signed informed consent and volunteered to join the study
  2. Aged >=18 years
  3. Patients with stage IIIb, IV, or relapsed non-small cell lung cancer diagnosed cytologically or histopathologically as EGFR/ALK-
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  5. At least one measurable lesion (according to RECIST 1.1)
  6. No prior systemic therapy for advanced/metastatic NSCLC
  7. contraception

Exclusion Criteria:

  1. Those who are allergic to drug treatment；
  2. Patients who were also treated with other immunodrugs or therapies；
  3. Patients who are participating in other intervention studies；
  4. Patients with other malignant tumors at the same time；
  5. Pregnant or lactating women；
  6. The investigator did not consider the patients eligible to participate in the study under any other circumstances.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) in second-line treatment of patients with non-small cell lung cancer based on Camrelizumab regimen
Time Frame: Up to 12 months
CR+PR
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Progression Free survival (PFS) in patients with non-small cell lung cancer based on first-line/second-line treatment with Camrelizumab
Time Frame: Up to 36 months
Progression free survival (PFS) according to RECIST 1.1
Up to 36 months
Evaluation of second progression-free survival (PFS2) in patients with non-small cell lung cancer based on Camrelizumab regimen
Time Frame: Up to 12 months
Evaluation of second progression-free survival (PFS2) in patients with non-small cell lung cancer based on Camrelizumab regimen
Up to 12 months
OS
Time Frame: Up to 12 months
Overall survival
Up to 12 months
To evaluate the safety of Camrelizumab based first/second line therapy in patients with non-small cell lung cancer
Time Frame: Up to 12 months
according to NCI-CTCAE version 5.0
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 21, 2022

Primary Completion (ANTICIPATED)

September 21, 2025

Study Completion (ANTICIPATED)

September 21, 2025

Study Registration Dates

First Submitted

June 28, 2022

First Submitted That Met QC Criteria

September 19, 2022

First Posted (ACTUAL)

September 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSCLC-RWS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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