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

NCT05653531 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-07-20

No results posted yet for this study

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.

Conditions

  • Immune Checkpoint Inhibitor
  • Lung Cancer
  • Liver Biomarkers
  • Transaminases

Interventions

OTHER

Blood sample

Liver blood tests (AST, ALT, PAL, GGT, bilirubin, PT) will be performed before each ICI injection during the first three injections and again at 6 months.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-25
Primary Completion
2023-04-01
Completion
2023-07-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05653531 on ClinicalTrials.gov