Non-small Cell Lung Cancer
Conditions
Brief summary
This observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of Chinese NSCLC patients.
Detailed description
Camrelizumab is a humanized antibody for cancer immunotherapy. The National Medical Products Administration (NMPA, China) approved camrelizumab as a first-line treatment of certain patients with NSCLC. This is a multicenter non-interventional study, NSCLC patients who have been treated with camrelizumab will be included. The main objective of this study is to evaluate the efficacy and safety of camrelizumab in the clinical practice.
Interventions
DRUGCamrelizumab
Camrelizumab-treated advanced NSCLC Patients with advanced non-small cell lung cancer treated with camrelizumab. Dosage form, dosage, frequency and duration of camrelizumab is determined according to the investigator's actual clinical practice.
Sponsors
Guangdong Association of Clinical Trials
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Sign the informed consent and volunteer to participate in the study; 2. Non-small cell lung cancer confirmed by histological/cytopathological tests; 3. Age ≥18; 4. The investigators determined that patients should receive camrelizumab alone or in combination.
Exclusion criteria
1. Patients who are also receiving other immunomedications or therapies; 2. Patients participating in other interventional studies; 3. Patients complicated with other malignant tumors; 4. Women who have been confirmed to be pregnant or lactating; 5. The Investigator considers the patient unsuitable for participation in any other condition of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AE,Grade 3-5 | From April 1, 2021 to Septeember 30, 2024 | Safety of the general population:Serious Adverse Events (AE)，Grade 3-5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MPR | From April 1, 2021 to December 30, 2024 | Neoadjuvant population: main pathological response rate (MPR) |
| R0 resection rate | From April 1, 2021 to December 30, 2022 | Neoadjuvant therapy population: R0 resection rate. |
| pCR | From April 1, 2021 to December 30, 2024 | Neoadjuvant therapy population: pathological complete response rate (pCR). |
| PFS | From April 1, 2021 to December 30, 2022 | Advanced non-small cell lung cancer: progression-free survival. |
| OS | From April 1, 2021 to December 30, 2022 | Advanced non-small cell lung cancer: Overall survival. |
| ORR | From April 1, 2021 to December 30, 2022 | Advanced non-small cell lung cancer: objective response rate (ORR). |
Contacts
Primary ContactChongrui Xu, Doctor
Backup ContactYilong Wu, Doctor
Outcome results
None listed