AJCC is Classified as IB-IIIC, A Multidisciplinary Team Assessment Determined That the Patient Was a Suitable Candidate for Radical Surgical Resection, NSCLC Diagnosed by Histology or Cytology, Overall Lung Function is Adequate for the Planned Lung Resection
Conditions
Keywords
NSCLC, IB-IIIC stage, Resectable NSCLC
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
Interventions
DRUGProbiotics 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.
Sponsors
Zhujiang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major pathological response | 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
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response | 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). |
Countries
China
Contacts
CONTACTXin Li
Outcome results
None listed