Gut bacteria and response to treatment before surgery in lung cancer
Studies gut bacteria in adults with operable non-small cell lung cancer receiving treatment.
Key facts
- Who runs it
- Guangdong Provincial People's Hospital
- Where
- Guangzhou, ChinaSee the site
- Trial code
- Registry title
- Microbiota in Neoadjuvant Chemoimmunotherapy for NSCLC
- Status
- Not yet recruiting
- People taking part
- 100 people, planned
- Started
- 31 Jul 2026
- Expected to end
- 31 Oct 2029
- Type of study
- Observational, 2 groups
- Treatments tested
- Neoadjuvant chemoimmunotherapy
- Record updated
- 7 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed, resectable non-small cell lung cancer (stage IIA-IIIB) who have no driver gene change and will have chemoimmunotherapy before surgery.
- Age
- 18 to 80 years
- Sex
- All
- Disease stage
- Newly diagnosed non-small cell lung cancer, stage IIA-IIIB, confirmed by tissue test, with no driver gene change. At least one measurable lesion (RECIST 1.1). Surgery must be possible.
- Earlier treatment
- No earlier systemic therapy or radiotherapy. No earlier chemotherapy or other cancer treatment. No earlier anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibodies.
- Biomarker or test result
- Driver gene-negative tumour. Must not be positive for hepatitis B surface antigen, treatable hepatitis C RNA, or HIV.
Main reasons for not taking part
- Needs steroid or other immune-suppressing treatment
- Antibiotics or an infection needing antibiotics in the past 3 months
- Probiotics in the 3 months before joining
- Active or past autoimmune disease, or brain metastases
- Pregnant or breastfeeding
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- Age between 18 and 80 years
- Newly diagnosed, driver gene-negative non-small cell lung cancer (NSCLC) confirmed by histopathology (Stage IIA-IIIB)
- At least one measurable lesion as defined by RECIST version 1.1; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- No prior systemic therapy or radiotherapy
- Eligible for surgical resection and suitable for neoadjuvant immunotherapy or chemotherapy as determined by multidisciplinary evaluation
- Signed written informed consent prior to study participation
- Adequate pulmonary ventilation and diffusion function confirmed by pre-enrollment pulmonary function test to allow for surgical resection
Who cannot take part
- Requirement for systemic glucocorticoid therapy or other immunosuppressive treatments
- Probiotic use within 3 months prior to enrollment
- Presence of bronchiectasis, concurrent pulmonary infections, pulmonary fibrosis, or uncontrolled diabetes mellitus
- Receipt of chemotherapy or any other cancer treatment prior to enrollment
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies
- Use of antibiotics or presence of infections requiring antibiotic therapy within the past 3 months
- Presence of obstructive pneumonia, cancerous cavitation, or active pulmonary tuberculosis
- Active or pre-existing autoimmune diseases
- Uncontrolled comorbidities including heart failure, uncontrolled hypertension, unstable angina, or interstitial lung disease
- Positive for hepatitis B surface antigen or detectable hepatitis C RNA requiring treatment
- Known history or positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
- Presence of a primary tumor in another organ
- Confirmed brain metastases by contrast-enhanced MRI before enrollment
- Pregnant or breastfeeding women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- Guangdong Provincial People's HospitalGuangzhou, ChinaContact: Xi Zhang M.D.No longer taking part
About the trial
What the trial wants to find out
Locally advanced lung cancer (LALC) has poor prognosis despite multimodal therapies. Neoadjuvant chemoimmunotherapy is now standard for resectable stage II-IIIB NSCLC, but patient responses vary. The gut microbiota, a key immune regulator, has been linked to immunotherapy efficacy, with microbial diversity predicting ICI response and fecal microbiota transplantation improving outcomes. While most studies focus on advanced disease, the microbiota's role in LALC during neoadjuvant therapy remains unclear. Exploring its dynamics may uncover novel biomarkers and strategies to optimize treatment
The 2 groups in the trial
- Response Group
a complete or partial response or stable disease lasting \>6 months were classified as responders
Treatment: Neoadjuvant chemoimmunotherapy
- Non-Response Group
patients who progressed on therapy or had stable disease \<6 months were classified as non-responders
Treatment: Neoadjuvant chemoimmunotherapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective Cohort Study Investigating Gut Microbiota as an Immunomodulatory Predictor of Response to Neoadjuvant Chemoimmunotherapy in Resectable Non-small-cell Lung Cancer
- Plain-language title
- Gut bacteria and response to treatment before surgery in lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07752589, who can take part
- Record updated
- 7 August 2026