Probiotic LR607 with neoadjuvant chemoimmunotherapy for resectable non-small cell lung cancer
Official title: Probiotics With High Expression of DL-peptidase (LR607) Can Enhance the Efficacy of Chemoradiotherapy in Resectable Stage IIA-IIIB Non-small Cell Lung Cancer: a Single-arm, Open-label, Multicenter, Phase II Clinical Trial
Run by Zhujiang Hospital · NCT07534033 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Zhujiang Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou) |
| Status | Recruiting |
| Started | December 6, 2025 |
| Main results expected | December 23, 2026 |
| Study ends | December 23, 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07534033 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Zhu Jiang Hospital of Southern Medical University
Guangzhou, China Recruiting
Study contacts
- Study coordinator: Xin Li
- Email: 1098353704@qq.com
- Phone: +8619878478083
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.