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

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

Inclusion Criteria:

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

Exclusion Criteria:

1. Including active autoimmune diseases
2. Recent use of immunosuppressants
3. Interstitial lung disease
4. Presence of other malignancies
5. History of immunotherapy
6. Active infection
7. Pregnancy or drug allergies