Probiotic effects on treatment response in lung cancer patients

The Impact of Bifidobacterium Lactis Supplementation on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients Receiving Immunotherapy (Nivolumab)

This study is testing whether a probiotic supplement can help lung cancer patients on immunotherapy respond better to their treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 19 Years to 90 Years
• Sex: All
• Sponsor: Necmettin Erbakan University (Academic / other)
• Drugs / interventions: prednisone, immunotherapy, nivolumab
• Locations: 1 site (Konya)
• Trial ID: NCT06428422 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with advanced or metastatic non-small cell lung cancer who are not currently on immunotherapy or probiotics.

Not a fit: Patients who have previously received specific antibody blockers or are currently taking probiotics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the effectiveness of immunotherapy for lung cancer patients, leading to improved survival rates.

How similar studies have performed: Other studies have shown promising results regarding the role of gut microbiota in enhancing cancer immunotherapy, indicating that this approach is supported by emerging evidence.

Eligibility criteria

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 this trial is running

Konya

• Necmettin Erbakan University — Konya, Turkey (Türkiye) (Recruiting)

Study contacts

• Study coordinator: Mehmet Artaç, MD

Conditions Metastatic Non-small Cell Lung Cancer; immunotherapy; lung cancer; probiotics; Bifidobacterium animalis; microbiota