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

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06100796

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer Metastatic Diabetes Mellitus	Combination Product: Pembrolizumab

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

Response Rate [12 weeks after starting immunotherapy regimen.]
CT evaluation for response rate measured by RECIST criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt	71515

Sponsors and Collaborators

Assiut University

Investigators

Study Chair: Doaa Ali Gamal, Assistant Lecturer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Momen Gebril Reyad Eltaher, Assistant lecturer, Assiut University

ClinicalTrials.gov Identifier:

NCT06100796

Other Study ID Numbers:

ICI outcomes in NSCLC with DM

First Posted:

Oct 25, 2023

Last Update Posted:

Oct 25, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Momen Gebril Reyad Eltaher, Assistant lecturer, Assiut University

NSCLC

ICI

OHA

Additional relevant MeSH terms:

Diabetes Mellitus

Hypoglycemic Agents

Pembrolizumab

Study Results

No Results Posted as of Oct 25, 2023