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

Phase 2RecruitingNCT07534033

Zhujiang Hospital46 enrolled

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

NSCLC Diagnosed by Histology or Cytology A Multidisciplinary Team Assessment Determined That the Patient Was a Suitable Candidate for Radical Surgical Resection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: Day 1 to 4 weeks

Secondary Outcomes

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).

Time frame: Day 1 to 4 Weeks