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

NCT07534033 | Recruiting Phase 2

• 1 other identifier: 2025-KY-396-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

NSCLC; IB-IIIC stage; Resectable NSCLC

Outcome Measures

Primary Outcomes (1)

• Major pathological response

  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).

  Day 1 to 4 weeks

Secondary Outcomes (1)

• Pathological Complete Response

  Day 1 to 4 Weeks

Study Arms (1)

Probiotics combined with neoadjuvant chemoimmunotherapy

EXPERIMENTAL

Drug: Probiotics combined with neoadjuvant chemoimmunotherapy

Interventions

Probiotics combined with neoadjuvant chemoimmunotherapy DRUG

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

Probiotics combined with neoadjuvant chemoimmunotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhu Jiang Hospital of Southern Medical University

Guangzhou, China

RECRUITING

Central Study Contacts

Xin Li

CONTACT

+8619878478083; 1098353704@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: April 16, 2026
• Study Start: December 6, 2025
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): December 23, 2027
• Last Updated: April 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)