Microbiota in Neoadjuvant Chemoimmunotherapy for NSCLC

NCT07752589 | Not Yet Recruiting

• 1 other identifier: KY2025-810-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Non-Small Cell Carcinoma of Lung; Gut Microbiomes; Neoadjuvant Chemoimmunotherapy

Keywords

NSCLC; Gut Microbiomes

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response (pCR)

  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

  From surgery to the end of the 1-month postoperative （periodPerioperative/Periprocedural）

Secondary Outcomes (5)

• Major pathological response (MPR)

  From surgery to the end of the 1-month postoperative （periodPerioperative/Periprocedural）

• Radiological response

  From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）

• Immune-related adverse event (irAE)

  From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）

• gut microbiomes

  From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）

• Disease free survival (DFS）

  From the postoperative period through 1 year after surgery

Study Arms (2)

Response Group

a complete or partial response or stable disease lasting \>6 months were classified as responders

Drug: Neoadjuvant chemoimmunotherapy

Non-Response Group

patients who progressed on therapy or had stable disease \<6 months were classified as non-responders

Drug: Neoadjuvant chemoimmunotherapy

Interventions

Neoadjuvant chemoimmunotherapy DRUG

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.

Non-Response Group; Response Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage IIA to IIIB non-small cell lung cancer (squamous or non-squamous subtype) who are planned to receive neoadjuvant immunotherapy combined with platinum-based doublet chemotherapy.

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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Southern Medical University, China: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510060, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

feces/blood/surgically resected lung lesions

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Wenzhao Zhong M.D., Doctoral degree

CONTACT

China:020-83827812; zx18898607918@163.com

Xi Zhang M.D.

CONTACT

86+18898607918; 1870892762@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: August 7, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: August 7, 2026

Record last verified: 2026-08

Locations

CN (1)