A Real World Study of Camrelizumab in the Treatment of Advanced Non-squamous Non-small-cell Lung Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
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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.
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Pharmacoeconomic evaluation of camrelizumab combined with chemotherapy in patients with EGFR mutation negative and ALK negative advanced non-squamous non-small cell lung cancer.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Camrelizumab treatment group 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
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.
Other Names:
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| Control treatment group 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. |
Outcome Measures
Primary Outcome Measures
- Progression free survival [2020-2022]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Histopathological diagnosis of non-squamous non-small cell lung cancer; 2) EGFR gene mutation negative and ALK negative, and did not receive systematic chemotherapy;
- 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:
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- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Pharmacy, Affiliated Hospital of Nantong University | Nantong | Jiangsu | China | 226000 |
Sponsors and Collaborators
- Affiliated Hospital of Nantong University
- The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Investigators
- Study Director: Zhiyuan Tang, Doctor, Affilication Hospital of Nantong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-K002-01