Microbiota in Neoadjuvant Chemoimmunotherapy for NSCLC
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorGuangdong Provincial People's Hospital
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Neoadjuvant chemoimmunotherapy
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Guangdong Provincial People's Hospital
Lead sponsor
Southern Medical University, China
Collaborator
Source ClinicalTrials.gov