Actively Recruiting

Phase Not Applicable
Age: 19Years - 90Years
All Genders
NCT06428422

The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients

Led by Necmettin Erbakan University · Updated on 2024-08-16

100

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

Sponsors

N

Necmettin Erbakan University

Lead Sponsor

H

Health Institutes of Turkey

Collaborating Sponsor

AI-Summary

What this Trial Is About

The aim of this study is to evaluate the effect of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on the clinical effectiveness of immunotherapy in patients diagnosed with metastatic non-small cell lung cancer who are receiving immunotherapy.

CONDITIONS

Official Title

The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients

Who Can Participate

Age: 19Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Volunteering to participate in the study.
  • Histologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC).
  • Patients must be in an advanced stage (incurable with surgery or radiotherapy) or have metastatic disease (Stage IV).
  • Male or female patients aged >18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status less than 2.
  • Laboratory findings must confirm adequate bone marrow function, indicated by:

White Blood Cell (WBC) count > 2,000/mm9, Neutrophil count > 1,500/mm9, Platelet count > 100,000/mm9

Not Eligible

You will not qualify if you...

  • Previously received treatment with any of the following antibody blockers: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4.
  • Currently taking probiotic supplements or consuming probiotic bacteria-supported yogurt and similar food supplements.
  • Antibiotic utilization within the past month.
  • Active interstitial lung disease or a history of interstitial lung disease requiring systemic steroid treatment.
  • A condition requiring systemic corticosteroids (greater than 10 mg of prednisone daily or equivalent) or who have received immunosuppressive treatment within 14 days prior to the first dose of the study.
  • Presence of uncontrolled adrenal insufficiency.
  • Pregnancy or breastfeeding.
  • Severe congestive heart failure (Class III or higher according to the New York Heart Association Functional Classification) or a history of myocarditis.
  • Uncontrolled cardiac arrhythmia that developed within six months prior to the start of the study.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Necmettin Erbakan University

Konya, Turkey (Türkiye), 42090

Actively Recruiting

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Research Team

M

Mehmet Artaç, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients | DecenTrialz