Clinical trial

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

Name
2022-K002-01
Description
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.
Trial arms
Trial start
2022-01-12
Estimated PCD
2024-08-31
Trial end
2024-08-31
Status
Recruiting
Treatment
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.
Arms:
Camrelizumab treatment group, Control treatment group
Other names:
Airuika, S20190027
Size
100
Primary endpoint
Progression free survival
2020-2022
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-07-20

1 organization

1 product

1 indication

Indication
lung cancer