Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AJCC is Classified as IB-IIIC | — | UNRESOLVED | — |
| A Multidisciplinary Team Assessment Determined That the Patient Was a Suitable Candidate for Radical Surgical Resection | — | UNRESOLVED | — |
| NSCLC Diagnosed by Histology or Cytology | — | UNRESOLVED | — |
| Overall Lung Function is Adequate for the Planned Lung Resection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Probiotics combined with neoadjuvant chemoimmunotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Probiotics combined with neoadjuvant chemoimmunotherapy
- interventionNames
- Drug: Probiotics combined with neoadjuvant chemoimmunotherapy
Primary outcomes (1)
- measure
- Major pathological response
- timeFrame
- Day 1 to 4 weeks
- description
- Major pathological response (MPR) was defined as ≤10% residual viable tumor cells in the tumor bed on pathological examination of the resected specimen in enrolled patients who underwent surgery within approximately 1 week after completion of three cycles of neoadjuvant therapy with a PD-1/PD-L1 inhibitor plus LR607 and platinum-based doublet chemotherapy (approximately 63 days).
Secondary outcomes (1)
- measure
- Pathological Complete Response
- timeFrame
- Day 1 to 4 Weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available