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Trial Title:
Effect of DM on Outcomes and Response Rate in Patients With Advanced NSCLC on ICI
NCT ID:
NCT06100796
Condition:
Non Small Cell Lung Cancer Metastatic
Diabetes Mellitus
Conditions: Official terms:
Diabetes Mellitus
Hypoglycemic Agents
Pembrolizumab
Conditions: Keywords:
NSCLC
DM
ICI
OHA
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Combination Product
Intervention name:
Pembrolizumab
Description:
Immune check inhibitor with OHA
Other name:
oral hypoglycemic agents
Summary:
Retrospectively investigating the effect of DM on response rate and outcomes during
immunotherapy treatment in patients with NSCLC in the last 5 years.
Detailed description:
Lung cancer continues to be the most common cause of cancer-related death worldwide for
both males and females despite the identification of clinically-actionable driver
mutations in genomic subgroups of patients. Non-small cell lung cancer (NSCLC) is the
most common histological diagnosis for 85% of lung cancer patients. Immune checkpoint
inhibitors (ICI) has significantly altered the prognosis for patients with advanced
non-small cell lung cancer (mNSCLC) as it has been shown to have distinct and
long-lasting impacts on survival in first and second line treatment. As a result,
immunotherapy has emerged as the backbone of care for people with NSCLC. Although some
patients benefit considerably from ICI, not all patients do. A comprehensive research
effort exists to identify and characterize variables that could predict or boost the
response to ICI.
At the same time, diabetes mellitus (DM) is becoming more prevalent globally and lung
cancer patients frequently suffer from a variety of comorbidities, including (DM).
However, its effect on treatment outcomes is still unclear, particularly in the era of
immunotherapy.
Criteria for eligibility:
Study pop:
All available patients from 2018 till December 2023 will be included.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- All consecutive patients with advanced Non Small Cell Lung Cancer who received
Immune Check Inhibitors alone or in combination with chemotherapy, either as first
line or as a subsequent line
Exclusion Criteria:
- None
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Assiut university
Address:
City:
Assiut
Zip:
71515
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Doaa Ali Gamal
Email:
vp_grad@aun.edu.eg
Start date:
October 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06100796
