Microbiota in Neoadjuvant Chemoimmunotherapy for NSCLC
Starting soon
Conditions studied: Non-Small Cell Carcinoma of Lung, Gut Microbiomes, Neoadjuvant Chemoimmunotherapy
In brief
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
Key facts
- Study ID
- NCT07752589
- Run by
- Guangdong Provincial People's Hospital
- People needed
- 100
- Starts
- 2026-07-31
- Expected to finish
- 2029-10-31
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- Requirement for systemic glucocorticoid therapy or other immunosuppressive treatments;
- Use of antibiotics or presence of infections requiring antibiotic therapy within the past 3 months;
- Probiotic use within 3 months prior to enrollment;
- Presence of obstructive pneumonia, cancerous cavitation, or active pulmonary tuberculosis;
- Presence of bronchiectasis, concurrent pulmonary infections, pulmonary fibrosis, or uncontrolled diabetes mellitus;
- Presence of a primary tumor in another organ;
- Receipt of chemotherapy or any other cancer treatment prior to enrollment;
- Confirmed brain metastases by contrast-enhanced MRI before enrollment;
- 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);
- Pregnant or breastfeeding women;
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies.
Where it is running
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.