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
• Status: Not yet recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

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