MedPath

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

Recruiting
Conditions
Lung Cancer
Interventions
Registration Number
NCT05387512
Lead Sponsor
Affiliated Hospital of Nantong University
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.

Detailed Description

1. 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.

2. 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.

3. Pharmacoeconomic evaluation of camrelizumab combined with chemotherapy in patients with EGFR mutation negative and ALK negative advanced non-squamous non-small cell lung cancer.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
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.
Read More
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.
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Camrelizumab treatment groupCamrelizumabThe 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.
Control treatment groupCamrelizumabThe 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.
Primary Outcome Measures
NameTimeMethod
Progression free survival2020-2022

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Department of Pharmacy, Affiliated Hospital of Nantong University

🇨🇳

Nantong, Jiangsu, China

Department of Pharmacy, Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
Zhiyuan Tang, Doctor
Contact
© Copyright 2025. All Rights Reserved by MedPath