NSCLC
Conditions
Brief summary
To explore the effectiveness and safety of Camrelizumab based cross-line therapy for patients with advanced NSCLC in the real world
Interventions
DRUGCamrelizumab
Cross - line treatment of Camrelizumab in non-small cell lung cancer
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Henan Cancer Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| OS | Up to 12 months | Overall survival |
| 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 |
Contacts
Primary ContactQi Ming Wang, Doctor's degree
Backup Contactzhen He, Doctor's degree
Outcome results
None listed