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

Recruiting

• Conditions: Diabetes Mellitus; Non Small Cell Lung Cancer Metastatic

• Registration Number: NCT06100796
• Lead Sponsor: Assiut University

Brief 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.

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-01
• Study First Submitted: 2023-10-14
• Study First Submitted QC: 2023-10-20
• Last Update Submitted: 2023-10-20
• Study First Posted: 2023-10-25
• Last Update Posted: 2023-10-25
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response Rate	12 weeks after starting immunotherapy regimen.	CT evaluation for response rate measured by RECIST criteria

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt