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)
Pathologic complete response (pCR) — From surgery to the end of the 1-month postoperative (periodPerioperative/Periprocedural) Pathological complete response (pCR) is defined as the absence of any residual invasive cancer in the resected primary tumor and lymph nodes following neoadjuvant therapy, as assessed by histopathological examination
Trial sites (1)
Facility
City
Region
Status
Guangdong Provincial People's Hospital
Guangzhou
Guangdong
More Guangdong Provincial People's Hospital trials in China
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.