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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05387512
• Other study ID #: 2022-K002-01
• Status: Recruiting
• Start date: January 12, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2023
• Source: Affiliated Hospital of Nantong University
• Contact: Zhiyuan Tang, Doctor
• Phone: 18862804577
• Email: tina2951[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Department of Pharmacy, Affiliated Hospital of Nantong University	Nantong	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University	The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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