Zhu Jiang Hospital of Southern Medical University
Guangzhou, China
Location status: Recruiting
Recruiting
NCT Number: NCT07534033
Phase II Clinical Study of Probiotic LR607 in Patients With Non-Small Cell Lung Cancer
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Probiotics combined with neoadjuvant chemoimmunotherapy
DrugThis clinical study aims to enhance efficacy by using functional probiotics selected from a Chinese food-grade probiotic library in combination with neoadjuvant chemoimmunotherapy.
Primary outcomes
-
Major pathological response
Time frame: Day 1 to 4 weeks
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
-
Pathological Complete Response
Time frame: Day 1 to 4 Weeks
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).
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Zhujiang Hospital
Other
Registry information
Official study 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
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Apr 16, 2026
- Registry last updated
- Apr 16, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.