A Real World Study of Camrelizumab in the Treatment of Advanced Non-squamous Non-small-cell Lung Cancer

Study Overview
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Brief Summary
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To provide sufficient scientific evidence for rational drug use of camrelizumab in the treatment of advanced non-squamous non-small cell lung cancer in China, efficacy，safety and cost-effectiveness of camrelizumab plus chemotherapy versus chemotherapy alone or chemotherapy plus antiangiogenic therapy in the first-line treatment of patients with advanced non-squamous non-small-cell lung cancer will be evaluated. Based on real world, the Markov Model was established to analyze the incremental cost-effectiveness in experimental group(camrelizumab plus chemotherapy), compared with control group (chemotherapy alone or chemotherapy plus antiangiogenic therapy). Deterministic sensitivity analysis and probabilistic sensitivity analysis will be performed.

Detailed Description
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Study on the safety and effectiveness of camrelizumab combined with chemotherapy in patients with EGFR mutation negative and ALK negative advanced non-squamous non-small cell lung cancer. Safety and effectiveness of standard chemotherapy alone or chemotherapy plus antiangiogenic therapy in first-line treatment of EGFR mutation negative and ALK negative patients with advanced non-squamous non-small cell lung cancer. Pharmacoeconomic evaluation of camrelizumab combined with chemotherapy in patients with EGFR mutation negative and ALK negative advanced non-squamous non-small cell lung cancer.

Official Title
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Efficacy，Safety and Cost-effectiveness Evaluation of Camrelizumab Plus Chemotherapy in First-line Treatment of Patients With Non-squamous Non-small-cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Camrelizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Histopathological diagnosis of non-squamous non-small cell lung cancer; 2) EGFR gene mutation negative and ALK negative, and did not receive systematic chemotherapy; 3) Older than 18 years of age; 4) Pathological stage IIIB or IV; 5) ECOG (Eastern Oncology Collaboration group) score 0-1; 4) Ecg and liver and kidney function are normal; 6) No second primary tumor disease or serious complications. Exclusion Criteria: 1) Patients with lung squamous cell carcinoma diagnosed by histopathology; (2) Patients with serious cardiovascular disease, active gastrointestinal bleeding, obvious coagulopathy, complicated with other malignant tumors, and drug allergy were excluded; 3) Patients with poor treatment compliance and incomplete case data.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Camrelizumab treatment group<br>The primary treatment is Camrelizumab combined with Pemetrexed and Platinum, secondary treatment with standard chemotherapy after progression. Reference regimen of Camrelizumab 200mg/3 weeks; Carboplatin reference regimen was AUC = 5 mg/mL/min; Cisplatin reference regimen was 75 mg/m2; Pemetrexed reference regimen was 500 mg/m2; paclitaxel liposome reference regimen is 135-175 mg/m2. | Drug: Camrelizumab<br>* Patients with EGFR-mutation-negative and ALK-negative advanced non-squamous non-small cell lung cancer were treated with first-line chemotherapy in combination with camrelizumab.<br>* Other names: Airuika, S20190027;|
| Control treatment group<br>The primary treatment is Pemetrexed and Platinum plus anti-angiogenic drugs, Secondary treatment is standard chemotherapy regimens after progression. Reference regimen of Carilizumab 200mg/3 weeks; Carboplatin reference regimen was AUC = 5 mg/mL/min; Cisplatin reference regimen was 75 mg/m2; Pemetrexed reference regimen was 500 mg/m2; paclitaxel liposome reference regimen is 135-175 mg/m2. | Drug: Camrelizumab<br>* Patients with EGFR-mutation-negative and ALK-negative advanced non-squamous non-small cell lung cancer were treated with first-line chemotherapy in combination with camrelizumab.<br>* Other names: Airuika, S20190027;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Kaplan-meier method was used to estimate median PFS and its 95%CI, and survival curves were plotted. Log-rank test was used to compare PFS between groups, and COX proportional risk model was used to estimate the HR and 95%CI between groups. Random forebrain metastases (yes/no) and number of metastases (≤3 metastases / >3 metastases) were considered as important covariables in the model. | 2020-2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer