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

Study Overview

• Status: Recruiting
• 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
• Intervention / Treatment: Drug: Probiotics combined with neoadjuvant chemoimmunotherapy

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xin Li; Phone Number: +8619878478083; Email: 1098353704@qq.com

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Zhu Jiang Hospital of Southern Medical University
    • Contact: Xiaolong He; Phone Number: 18620071640; Email: hxl2027315@smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics combined with neoadjuvant chemoimmunotherapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response	Pathological complete response (pCR) was defined as no residual viable tumor cells in the resected primary lung tumor and all resected regional lymph nodes 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

Collaborators and Investigators

• Sponsor: Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2025
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): December 23, 2027

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: NSCLC; Resectable NSCLC; IB-IIIC stage
• Other Study ID Numbers: 2025-KY-396-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No