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NCT05547737 Clinical Trial

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

NSCLC Clinical Trial

— NSCLC  

Official title:
Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05547737
Other study ID # NSCLC-RWS-001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 21, 2022
Est. completion date September 21, 2025

Study information
Verified date May 2022
Source Henan Cancer Hospital
Contact Qi Ming Wang, Doctor's degree
Phone 13783590691
Email qimingwang1006@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To explore the effectiveness and safety of Camrelizumab based cross-line therapy for patients with advanced NSCLC in the real world

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date September 21, 2025
Est. primary completion date September 21, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Camrelizumab
Cross - line treatment of Camrelizumab in non-small cell lung cancer

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Henan Cancer Hospital Jiangsu HengRui Medicine Co., Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) in second-line treatment of patients with non-small cell lung cancer based on Camrelizumab regimen CR+PR Up to 12 months
Secondary Evaluation of Progression Free survival (PFS) in patients with non-small cell lung cancer based on first-line/second-line treatment with Camrelizumab Progression free survival (PFS) according to RECIST 1.1 Up to 36 months
Secondary Evaluation of second progression-free survival (PFS2) in patients with non-small cell lung cancer based on Camrelizumab regimen Evaluation of second progression-free survival (PFS2) in patients with non-small cell lung cancer based on Camrelizumab regimen Up to 12 months
Secondary OS Overall survival Up to 12 months
Secondary To evaluate the safety of Camrelizumab based first/second line therapy in patients with non-small cell lung cancer according to NCI-CTCAE version 5.0 Up to 12 months
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