Clinical Significance of Hepatic Biomarkers in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

Not Applicable

Withdrawn

• Conditions: Liver Biomarkers; Lung Cancer; Immune Checkpoint Inhibitor; Transaminases

• Registration Number: NCT05653531
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Lung cancer is the leading cause of cancer death worldwide. The emergence of immune checkpoint inhibitors (ICIs) has revolutionized the treatment of lung cancer over the past 10 years. Nivolumab, ipilimumab, pembrolizumab, atezolizumab, and durvalumab have been successively approved in non-small cell lung cancer, small cell lung cancer, and pleural mesothelioma. Although the efficacy of ICIs is remarkable in some patients, the objective response rate is only about 20%. The development of predictive biomarkers for treatment response is essential. Non-invasive methods and easily accessible biomarkers at low cost are required.ICIs activate the immune system through the inhibition of checkpoints (PD-L1, PD-1). The immune system and the liver are interconnected and constantly interact through a complex regulatory system. Patients with lung cancer frequently suffer from liver damage, due to metastases, treatments or underlying pathologies. The objective of the study is to evaluate the clinical significance of key liver biomarkers (AST, ALT, PAL, GGT, bilirubin, PT) in patients with lung cancer treated with ICI.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-25
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-16
• Primary Completion: 2023-04-01
• Status Verified: 2023-07
• Study Completion: 2023-07-01
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Inclusion criteria:
• Age > 18 years
• Patient with lung cancer of any histological type
• Initiation of ICI therapy
• Signed consent for the study

Exclusion Criteria

• Patient with previous ICI treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
basal ALT blood concentration in lung cancer patients treated with ICI determined	one year	To Identify baseline blood ALT concentration as a predictive liver biomarker of treatment response in lung cancer patients treated with ICI.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France