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NCT06100796 Clinical Trial

Effect of DM on Outcomes and Response Rate in Patients With Advanced NSCLC on ICI

Diabetes Mellitus Clinical Trial

— NSCLC  

Official title:
Effect of Diabetes Mellitus on Outcomes and Response Rate in Patients With Advanced NSCLC on Immunotherapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06100796
Other study ID # ICI outcomes in NSCLC with DM
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date December 31, 2024

Study information
Verified date October 2023
Source Assiut University
Contact Momen Eltaher
Phone +96893981742
Email drmeem@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospectively investigating the effect of DM on response rate and outcomes during immunotherapy treatment in patients with NSCLC in the last 5 years.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• Pembrolizumab
Immune check inhibitor with OHA

Locations
Country Name City State
Egypt Assiut university Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response Rate CT evaluation for response rate measured by RECIST criteria 12 weeks after starting immunotherapy regimen.
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