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

RECRUITINGPhase 2Sponsored by Zhujiang Hospital
Actively Recruiting
PhasePhase 2
SponsorZhujiang Hospital
Started2025-12-06
Est. completion2026-12-23
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07534033

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions6

A Multidisciplinary Team Assessment Determined That the Patient Was a Suitable Candidate for Radical Surgical ResectionAJCC is Classified as IB-IIICCancerLung CancerNSCLC Diagnosed by Histology or CytologyOverall Lung Function is Adequate for the Planned Lung Resection

Interventions1

Probiotics combined with neoadjuvant chemoimmunotherapy

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