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

NCT06428422 | Recruiting

• 1 other identifier: BL-32769
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metastatic Non-small Cell Lung Cancer

Keywords

immunotherapy; lung cancer; probiotics; Bifidobacterium animalis; microbiota

Outcome Measures

Primary Outcomes (3)

• Evaluation of Clinical Response

  The clinical impact of the immunotherapy will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1 criteria based on radiological analysis.

  Week 12

• Progression-free survival

  The progression-free survival (PFS) period will be defined as the interval between the initiation of treatment and the date of radiological progression.

  Basaline and the date of radiological progression

• Overall survival

  The overall survival (OS) period will be defined as the interval between the date of disease diagnosis and death from any cause.

  Basaline and the date of death from any case

Secondary Outcomes (2)

• Intestinal microbiota modulation

  Basaline and Week 12

• Immunological findings

  Basaline and Week 12

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive an oral dosage of 4 x 10\^9 cfu/g/day Bifidobacterium animalis subsp. lactis BL-04 strain (Danisco, USA) and 1 gram of maltodextrin (Danisco, USA) in conjunction with the conventional treatment, which consisted of systemic cancer immunotherapy with nivolumab at a dose of 3 mg/kg administered intravenously every two weeks. The immunotherapy with nivolumab will be completed in twelve weeks. A probiotic strain is provided to the intervention group in the form of a sachet. Patients will be asked to pour the entire sachet into a glass of water (100 mL, room temperature), mix, and drink it every day for 12 weeks.

Dietary Supplement: Bifidobacterium animalis subsp. lactis Bl-04

Plasebo group

PLACEBO COMPARATOR

The plasebo group will receive the conventional treatment, which consisted of systemic cancer immunotherapy with nivolumab at a dose of 3 mg/kg administered intravenously every two weeks. The immunotherapy with nivolumab will be completed in twelve weeks. In addition to the traditional treatment (nivolumab), the plasebo group will be given 1 g/day maltodextrin (Danisco, USA) as placebo. Maltodextrin will be provided to the intervention group in the form of a sachet. Patients will be asked to pour the entire sachet into a glass of water (100 mL, room temperature), mix, and drink it every day for 12 weeks.

Other: Plasebo

Interventions

Bifidobacterium animalis subsp. lactis Bl-04 DIETARY_SUPPLEMENT

4 x 10\^9 cfu/g/day Bifidobacterium animalis subsp. lactis Bl-04 for 12 weeks

Intervention group

Plasebo OTHER

1 g/day maltodextrin for 12 weeks

Plasebo group

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Necmettin Erbakan University: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Necmettin Erbakan University

Konya, 42090, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Mehmet Artaç, MD

CONTACT

+90332236000; martac@erbakan.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: August 12, 2024
• Primary Completion: October 31, 2025
• Study Completion (Estimated): December 20, 2026
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)