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

Not yet recruiting

• Conditions: NSCLC

• Registration Number: NCT05547737
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-09-19
• Last Update Submitted: 2022-09-19
• Study Start: 2022-09-21
• Study First Posted: 2022-09-21
• Last Update Posted: 2022-09-21
• Primary Completion: 2025-09-21
• Study Completion: 2025-09-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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