NCT06100796

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

October 14, 2023

Last Update Submit

October 20, 2023

Conditions

Non Small Cell Lung Cancer MetastaticDiabetes Mellitus

Keywords

NSCLCDMICIOHA

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    CT evaluation for response rate measured by RECIST criteria

    12 weeks after starting immunotherapy regimen.

Interventions

PembrolizumabCOMBINATION_PRODUCT

Immune check inhibitor with OHA

Also known as: oral hypoglycemic agents

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All available patients from 2018 till December 2023 will be included.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

pembrolizumabHypoglycemic Agents

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Doaa Ali Gamal

    Assistant Lecturer

    STUDY CHAIR

Central Study Contacts

Momen Eltaher

CONTACT

+96893981742drmeem@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

October 14, 2023

First Posted

October 25, 2023

Study Start

October 1, 2023

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

EG(1)