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
PD-1 inhibitors
Sponsors
Guangdong Association of Clinical Trials
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Age ≥18 years old; 2. Histopathological diagnosed confirmed non-small cell lung cancer; 3. Have received at least one camrelizumab injection between August 1, 2019 and December 31, 2020; 4. Traceable cases.
Exclusion criteria
1. Patients who have received other immunotherapy at the same time; 2. Patients who were participating in other intervention studies; 3. Patients with other malignant tumors; 4. The researcher believes that the patient is not suitable to participate in this study with any other conditions .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR | From August 1, 2019 to June 31, 2021 | Neoadjuvant therapy population: pathological complete response rate (pCR). |
| R0 resection rate. | From August 1, 2019 to June 31, 2021 | Neoadjuvant therapy population: R0 resection rate. |
| ORR | From August 1, 2019 to June 31, 2021 | Advanced non-small cell lung cancer: objective response rate (ORR). |
| 6-month PFS% | From August 1, 2019 to June 31, 2021 | Advanced non-small cell lung cancer: 6-month progression-free survival rate (PFS%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| operative rate | From August 1, 2019 to June 31, 2021 | Neoadjuvant population: operative rate |
| perioperative mortality | From August 1, 2019 to June 31, 2021 | Neoadjuvant population: perioperative mortality |
| AE | From August 1, 2019 to June 31, 2021 | Safety of the general population: Adverse Events (AE). |
| iORR | From August 1, 2019 to June 31, 2021 | First-line combined treatment population: median treatment cycle number, intracranial objective response rate (iORR) in patients with brain metastasis. |
| incidence of major postoperative complications | From August 1, 2019 to June 31, 2021 | Neoadjuvant population: incidence of major postoperative complications (within 30 days after surgery). |
| SAE | From August 1, 2019 to June 31, 2021 | Safety of the general population: Serious Adverse Events (SAE). |
| iPFS | From August 1, 2019 to June 31, 2021 | First-line combined treatment population: median treatment cycle number, intracranial progression-free survival (iPFS) in patients with brain metastasis. |
| MPR | From August 1, 2019 to June 31, 2021 | Neoadjuvant population: main pathological response rate (MPR) |
Countries
China
Contacts
Primary ContactXu Chongrui, Doctor
Outcome results
None listed