Phase II Clinical Study of Probiotic LR607 in Patients With Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotics combined with neoadjuvant chemoimmunotherapy.
- Who it may be relevant to
- Registry conditions: NSCLC Diagnosed by Histology or Cytology, A Multidisciplinary Team Assessment Determined That the Patient Was a Suitable Candidate for Radical Surgical Resection, Overall Lung Function is Adequate for the Planned Lung Resection, AJCC is Classified as IB-IIIC. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Interventions
- Drug Probiotics 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.
Primary outcome measures
- Major pathological response [Time frame: Day 1 to 4 weeks]
Secondary outcome measures (1)
- Pathological Complete Response [Time frame: Day 1 to 4 Weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Including active autoimmune diseases
- Recent use of immunosuppressants
- Interstitial lung disease
- Presence of other malignancies
- History of immunotherapy
- Active infection
- Pregnancy or drug allergies
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhu Jiang Hospital of Southern Medical University — Guangzhou
Identifiers
NCT: NCT07534033 · 2025-KY-396-01