Non-Small Cell Carcinoma of LungNCT07752589
Microbiota in Neoadjuvant Chemoimmunotherapy for NSCLC
An observational study of Non-Small Cell Carcinoma of Lung and Gut Microbiomes, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Small Cell Carcinoma of Lung, Gut Microbiomes, Neoadjuvant Chemoimmunotherapy
- What is being tested?
- Neoadjuvant chemoimmunotherapy
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2026to 31 Oct 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510060
Xi Zhang M.D., China:020-83827812, zx18898607918@163.com
About this study
Official title: A Prospective Cohort Study Investigating Gut Microbiota as an Immunomodulatory Predictor of Response to Neoadjuvant Chemoimmunotherapy in Resectable Non-small-cell Lung Cancer
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
- Being tested
- Neoadjuvant chemoimmunotherapy
- Keywords
- NSCLC, Gut Microbiomes
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemoimmunotherapyDrug
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 group | Role | What they receive |
|---|---|---|
| Response Group | a complete or partial response or stable disease lasting >6 months were classified as responders Receives: Drug: Neoadjuvant chemoimmunotherapy | |
| Non-Response Group | patients who progressed on therapy or had stable disease <6 months were classified as non-responders Receives: Drug: Neoadjuvant chemoimmunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From surgery to the end of the 1-month postoperative （periodPerioperative/Periprocedural）
Secondary outcomes (5)
Major pathological response (MPR)
Major pathological response (MPR) is defined as ≤10% residual viable tumor cells in the resected primary tumor specimen after neoadjuvant therapy, as determined by histopathological evaluation
Measured: From surgery to the end of the 1-month postoperative （periodPerioperative/Periprocedural）
Radiological response
Defined as radiographic change assesed by RECIST 1.1
Measured: From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）
Immune-related adverse event (irAE)
defined as all levels of adverse drug reactions in antitumor immunotherapy that are judged to be related to immune mechanisms, excluding non-specific infusion reactions
Measured: From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）
gut microbiomes
Defined as microbial composition, diversity, and functional activity measured by metagenomic sequencing
Measured: From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）
Disease free survival (DFS）
Defined as the time from the date of definitive treatment (e.g., surgery) until the date of recurrence of cancer, the occurrence of a second primary cancer, or death from any cause, whichever occurs first.
Measured: From the postoperative period through 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Carcinoma of LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Medical University, China
- Responsible party
- Principal investigator, Wen-zhao ZHONG, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752589
- Sponsor's protocol ID
- KY2025-810-01
- Status last verified
- Aug 2026
- First submitted
- 14 Nov 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided