Efficacy and Safety of Camrelizumab in Real-World Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Camrelizumab for Chinese NSCLC Patients: a Retrospective, Observational, Multicenter Real-World Study

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Camrelizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old; Histopathological diagnosed confirmed non-small cell lung cancer; Have received at least one camrelizumab injection between August 1, 2019 and December 31, 2020; Traceable cases. Exclusion Criteria: Patients who have received other immunotherapy at the same time; Patients who were participating in other intervention studies; Patients with other malignant tumors; The researcher believes that the patient is not suitable to participate in this study with any other conditions .

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Camrelizumab-treated advanced NSCLC<br>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. | Drug: Camrelizumab<br>* PD-1 inhibitors<br>* Other names: SHR-1210;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |