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Clinical Trials in China / NCT07752589
Starting soon Observational

Microbiota in Neoadjuvant Chemoimmunotherapy for NSCLC

NCT07752589 · tracked via the Priya Life Science China tracker
Sponsor
Guangdong Provincial People's Hospital
Phase
Observational
Started
2026-07-31
Last updated
2026-08-07

Condition(s) studied

Non-Small Cell Carcinoma of LungGut MicrobiomesNeoadjuvant Chemoimmunotherapy

Investigational drug(s) / intervention(s)

Neoadjuvant chemoimmunotherapy

Neoadjuvant chemoimmunotherapy: neoadjuvant chemoimmunotherapy typically involves a PD-1 inhibitor-such as nivolumab, sintilimab, or camrelizumab-combined with platinum-based doublet chemotherapy (e.g., paclitaxel plus cisplatin for squamous cell carcinoma, or pemetrexed plus cisplatin for adenocarcinoma). The standard regimen includes three treatment cycles administered every three weeks, followed by surgical resection within 4-6 weeks. Some patients may receive up to one year of adjuvant immunotherapy postoperatively.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Age between 18 and 80 years; 2. Newly diagnosed, driver gene-negative non-small cell lung cancer (NSCLC) confirmed by histopathology (Stage IIA-IIIB); 3. At least one measurable lesion as defined by RECIST version 1.1; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 4. No prior systemic therapy or radiotherapy; 5. Eligible for surgical resection and suitable for neoadjuvant immunotherapy or chemotherapy as determined by multidisciplinary evaluation; 6. Signed written informed consent prior to study participation; 7. Adequate pulmonary ventilation and diffusion function confirmed by pre-enrollment pulmonary function test to allow for surgical resection. Exclusion Criteria: 1. Requirement for systemic glucocorticoid therapy or other immunosuppressive treatments; 2. Use of antibiotics or presence of infections requiring antibiotic therapy within the past 3 months; 3. Probiotic use within 3 months prior to enrollment; 4. Presence of obstructive pneumonia, cancerous cavitation, or active pulmonary tuberculosis; 5. Presence of bronchiectasis, concurrent pulmonary infections, pulmonary fibrosis, or uncontrolled diabetes mellitus; 6. Presence of a primary tumor in another organ; 7. Receipt of chemotherapy or any other cancer treatment prior to enrollment; 8. Confirmed brain metastases by contrast-enhanced MRI before enrollment; 9. Active or pre-existing autoimmune diseases; 10. Uncontrolled comorbidities including heart failure, uncontrolled hypertension, unstable angina, or interstitial lung disease; 11. Positive for hepatitis B surface antigen or detectable hepatitis C RNA requiring treatment; 12. Known history or positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); 13. Pregnant or breastfeeding women; 14. Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Guangdong Provincial People's Hospital Guangzhou Guangdong

More Guangdong Provincial People's Hospital trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07752589 on ClinicalTrials.gov ↗ ← All trials in China