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Microbiota in Neoadjuvant Chemoimmunotherapy for NSCLC

ConditionsNon-Small Cell Carcinoma of LungGut MicrobiomesNeoadjuvant Chemoimmunotherapy
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

This trial accepts healthy volunteers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Response Group1 intervention
Group B: Non-Response Group1 intervention

Trial outcomes

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

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

Secondary outcomes

1

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

Time frame
From surgery to the end of the 1-month postoperative （periodPerioperative/Periprocedural）
2

Radiological response

Defined as radiographic change assesed by RECIST 1.1

Time frame
From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）
3

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

Time frame
From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）
4

gut microbiomes

Defined as microbial composition, diversity, and functional activity measured by metagenomic sequencing

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

Southern Medical University, China

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: