Probiotic LR607 with neoadjuvant chemoimmunotherapy for resectable 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 team will try giving adults with resectable stage IB–IIIC non-small cell lung cancer a daily probiotic (Lactobacillus rhamnosus LR607) alongside neoadjuvant chemoimmunotherapy to see if it improves tumor response and is safe.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT07534033 on ClinicalTrials.gov |
What this trial studies
This is a Phase II interventional study that adds daily oral LR607 to standard neoadjuvant chemoimmunotherapy for adults with histologically confirmed, resectable NSCLC (AJCC IB–IIIC). Participants take LR607 each day for about three months and visit the hospital monthly for safety checks and tests, followed by planned surgical resection. Primary outcomes include major pathological response and treatment-related adverse events, and the study will also analyze changes in gut microbiota composition at the species level and gut metabolites. Tumor recurrence and pathological response data will be recorded during follow-up.
Who should consider this trial
Good fit: Adults (≥18) with newly diagnosed, histologically confirmed resectable NSCLC stage IB–IIIC who are ECOG 0–1, have measurable disease and adequate organ function for chemotherapy and immunotherapy are eligible.
Not a fit: Patients with active autoimmune disease, recent immunosuppressant use, interstitial lung disease, prior immunotherapy, other active malignancies, active infection, pregnancy, or known drug allergies are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, LR607 could raise the rate of major pathological response to neoadjuvant chemoimmunotherapy and may help modulate side effects by altering the gut microbiome.
How similar studies have performed: Previous research has shown promising links between the gut microbiome and immunotherapy response in several cancers, but the use of a specific probiotic like LR607 with neoadjuvant chemoimmunotherapy is novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou
- Zhu Jiang Hospital of Southern Medical University — Guangzhou, China (Recruiting)
Study contacts
- Study coordinator: Xin Li
- Email: 1098353704@qq.com
- Phone: +8619878478083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.