Probiotic effects on treatment response in lung cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the impact of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on the effectiveness of immunotherapy in patients with metastatic non-small cell lung cancer. The research aims to explore how gut microbiota influences the immune response to cancer treatment, potentially improving patient outcomes. Participants will receive either the probiotic or a placebo while undergoing immunotherapy. The study seeks to identify the role of microbiota as a biomarker for personalized treatment protocols in cancer care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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/mm³, Neutrophil count \> 1,500/mm³,Platelet count \> 100,000/mm³

Exclusion Criteria:

* 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.

Where it's running

• Necmettin Erbakan University
  Konya, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Mehmet Artaç, MD
• Email: martac@erbakan.edu.tr
• Phone: +90332236000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.