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This observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of Chinese NSCLC patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | PD-1 inhibitors |
|
| Measure | Description | Time Frame |
|---|---|---|
| pCR | Neoadjuvant therapy population: pathological complete response rate (pCR). | From August 1, 2019 to June 31, 2021 |
| R0 resection rate. | Neoadjuvant therapy population: R0 resection rate. | From August 1, 2019 to June 31, 2021 |
| ORR | Advanced non-small cell lung cancer: objective response rate (ORR). | From August 1, 2019 to June 31, 2021 |
| 6-month PFS% | Advanced non-small cell lung cancer: 6-month progression-free survival rate (PFS%). | From August 1, 2019 to June 31, 2021 |
| Measure | Description | Time Frame |
|---|---|---|
| MPR | Neoadjuvant population: main pathological response rate (MPR) | From August 1, 2019 to June 31, 2021 |
| operative rate | Neoadjuvant population: operative rate |
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Inclusion Criteria:
Exclusion Criteria:
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Total 450 patients who have received camrelizumab with NSCLC will be enrolled. The patients should be registered consecutively in each site.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Chongrui, Doctor | Contact | +8618696164925 | xucr001@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wu Yilong, Doctor | Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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| From August 1, 2019 to June 31, 2021 |
| perioperative mortality | Neoadjuvant population: perioperative mortality | From August 1, 2019 to June 31, 2021 |
| incidence of major postoperative complications | Neoadjuvant population: incidence of major postoperative complications (within 30 days after surgery). | From August 1, 2019 to June 31, 2021 |
| iORR | First-line combined treatment population: median treatment cycle number, intracranial objective response rate (iORR) in patients with brain metastasis. | From August 1, 2019 to June 31, 2021 |
| iPFS | First-line combined treatment population: median treatment cycle number, intracranial progression-free survival (iPFS) in patients with brain metastasis. | From August 1, 2019 to June 31, 2021 |
| AE | Safety of the general population: Adverse Events (AE). | From August 1, 2019 to June 31, 2021 |
| SAE | Safety of the general population: Serious Adverse Events (SAE). | From August 1, 2019 to June 31, 2021 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |