NSCLC Diagnosed by Histology or CytologyPhase 2NCT07534033
Phase II Clinical Study of Probiotic LR607 in Patients With Non-Small Cell Lung Cancer
A Phase 2 study testing Probiotics combined with neoadjuvant chemoimmunotherapy in people with NSCLC Diagnosed by Histology or Cytology and A Multidisciplinary Team Assessment Determined That the Patient Was a Suitable Candidate for Radical Surgical Resection, run by Zhujiang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- NSCLC Diagnosed by Histology or Cytology, A Multidisciplinary Team Assessment Determined That the Patient Was a Suitable Candidate for Radical Surgical Resection, Overall Lung Function is Adequate for the Planned Lung Resection
- What is being tested?
- Probiotics combined with neoadjuvant chemoimmunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2025to 23 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Including active autoimmune diseases
- Recent use of immunosuppressants
- Interstitial lung disease
- Presence of other malignancies
- History of immunotherapy
- Active infection
- Pregnancy or drug allergies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhu Jiang Hospital of Southern Medical University
Guangzhou
Xiaolong He, 18620071640, hxl2027315@smu.edu.cn
About this study
Official 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
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?
Read more
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
- Conditions
- NSCLC Diagnosed by Histology or Cytology, A Multidisciplinary Team Assessment Determined That the Patient Was a Suitable Candidate for Radical Surgical Resection, Overall Lung Function is Adequate for the Planned Lung Resection, AJCC is Classified as IB-IIIC
- Being tested
- Probiotics combined with neoadjuvant chemoimmunotherapy
- Keywords
- NSCLC, IB-IIIC stage, Resectable NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics combined with neoadjuvant chemoimmunotherapyDrug
This clinical study aims to enhance efficacy by using functional probiotics selected from a Chinese food-grade probiotic library in combination with neoadjuvant chemoimmunotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics combined with neoadjuvant chemoimmunotherapy | Experimental | Not described Receives: Drug: Probiotics combined with neoadjuvant chemoimmunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1 to 4 weeks
Secondary outcomes (1)
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).
Measured: Day 1 to 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start6 Dec 2025
- Primary completion23 Dec 2026 (estimated)
- Study completion23 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Diagnosed by Histology or CytologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534033
- Sponsor's protocol ID
- 2025-KY-396-01
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07534033
- Acronym / sponsor ID
- 2025-KY-396-01
- Conditions
- NSCLC Diagnosed by Histology or Cytology, A Multidisciplinary Team Assessment Determined That the Patient Was a Suitable Candidate for Radical Surgical Resection, Overall Lung Function is Adequate for the Planned Lung Resection, AJCC is Classified as IB-IIIC
- Keywords
- NSCLC, IB-IIIC stage, Resectable NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 6 Dec 2025 (actual)
- Primary completion
- 23 Dec 2026 (estimated)
- Study completion
- 23 Dec 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotics combined with neoadjuvant chemoimmunotherapy | Experimental | Drug: Probiotics combined with neoadjuvant chemoimmunotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Including active autoimmune diseases
- Recent use of immunosuppressants
- Interstitial lung disease
- Presence of other malignancies
- History of immunotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotics combined with neoadjuvant chemoimmunotherapyThis clinical study aims to enhance efficacy by using functional probiotics selected from a Chinese food-grade probiotic library in combination with neoadjuvant chemoimmunotherapy. | Drug | Probiotics combined with neoadjuvant chemoimmunotherapy |
Primary outcome
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).
1 secondary outcome
Pathological Complete Response
Time frame: Day 1 to 4 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotics combined with neoadjuvant chemoimmunotherapy in people with NSCLC Diagnosed by Histology or Cytology and A Multidisciplinary Team Assessment Determined That the Patient Was a Suitable Candidate for Radical Surgical Resection, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Li (+8619878478083, 1098353704@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response (time frame: Day 1 to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.