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RecruitingPhase 2NCT07534033

Phase II Clinical Study of Probiotic LR607 in Patients With Non-Small Cell Lung Cancer

Probiotics With High Expression of DL-peptidase (LR607) Can Enhance the Efficacy of Chemoradiotherapy in Resectable Stage IIB-IIIB Non-small Cell Lung Cancer: a Single-arm, Open-label, Multicenter, Phase II Clinical Trial

Sponsor

Zhujiang Hospital

Enrollment

46 participants

Start Date

Dec 6, 2025

Study Type

INTERVENTIONAL

Conditions

NSCLC Diagnosed by Histology or CytologyA Multidisciplinary Team Assessment Determined That the Patient Was a Suitable Candidate for Radical Surgical ResectionOverall Lung Function is Adequate for the Planned Lung ResectionAJCC is Classified as IB-IIIC

Summary

The goal of this clinical trial is to understand whether Lactobacillus rhamnosus LR607 can enhance neoadjuvant chemoimmunotherapy for adult patients with non-small cell lung cancer. It will also evaluate the safety of LR607. The main questions it aims to answer include: Can LR607 improve the major pathological response of neoadjuvant chemoimmunotherapy? What is the relationship between LR607 combined with neoadjuvant chemoimmunotherapy and treatment-related adverse reactions? What changes occur in the gut microbiota composition at the species level and gut metabolites of subjects after LR607 treatment? Participants will: Take LR607 daily for 3 months Visit the hospital for check-ups and examinations every month Record their pathological response, tumor recurrence, and treatment-related adverse reactions

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • Histologically confirmed newly diagnosed patients
  • ECOG performance status 0-1
  • Age ≥18 years
  • Measurable lesions (RECIST v1.1)
  • Organ function meeting the requirements for chemotherapy and immunotherapy.

Exclusion Criteria7

  • Including active autoimmune diseases
  • Recent use of immunosuppressants
  • Interstitial lung disease
  • Presence of other malignancies
  • History of immunotherapy
  • Active infection
  • Pregnancy or drug allergies

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Interventions

DRUGProbiotics combined with neoadjuvant chemoimmunotherapy

This clinical study aims to enhance efficacy by using functional probiotics selected from a Chinese food-grade probiotic library in combination with neoadjuvant chemoimmunotherapy.

Locations(1)

Zhu Jiang Hospital of Southern Medical University

Guangzhou, China

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NCT07534033