Efficacy and Safety of Camrelizumab in Real-World Prospective 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 Prospective, 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: Sign the informed consent and volunteer to participate in the study; Non-small cell lung cancer confirmed by histological/cytopathological tests; Age ≥18; The investigators determined that patients should receive camrelizumab alone or in combination. Exclusion Criteria: Patients who are also receiving other immunomedications or therapies; Patients participating in other interventional studies; Patients complicated with other malignant tumors; Women who have been confirmed to be pregnant or lactating; The Investigator considers the patient unsuitable for participation in any other condition of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Camrelizumab|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE,Grade 3-5 | Safety of the general population:Serious Adverse Events (AE)，Grade 3-5. | From April 1, 2021 to Septeember 30, 2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pCR | Neoadjuvant therapy population: pathological complete response rate (pCR). | From April 1, 2021 to December 30, 2024 | 
| MPR | Neoadjuvant population: main pathological response rate (MPR) | From April 1, 2021 to December 30, 2024 | 
| R0 resection rate | Neoadjuvant therapy population: R0 resection rate. | From April 1, 2021 to December 30, 2022 | 
| ORR | Advanced non-small cell lung cancer: objective response rate (ORR). | From April 1, 2021 to December 30, 2022 | 
| PFS | Advanced non-small cell lung cancer: progression-free survival. | From April 1, 2021 to December 30, 2022 | 
| OS | Advanced non-small cell lung cancer: Overall survival. | From April 1, 2021 to December 30, 2022 |