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

NCT ID: NCT06100796

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Non Small Cell Lung Cancer Metastatic Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Pembrolizumab

Immune check inhibitor with OHA

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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oral hypoglycemic agents

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Momen Gebril Reyad Eltaher

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Doaa Ali Gamal

Role: STUDY_CHAIR

Assistant Lecturer

Locations

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Assiut university

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Momen Eltaher

Role: CONTACT

+96893981742

Facility Contacts

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Doaa Ali Gamal

Role: primary

Other Identifiers

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ICI outcomes in NSCLC with DM

Identifier Type: -

Identifier Source: org_study_id

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