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Not yet recruiting NCT06613308

Association Between Microbiome and the Efficacy and Safety of PD-1/PD-L1 Blockade in Resectable NSCLC

— Observational Lung Cancer (NSCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neoadjuvant immunotherapy combined with chemotherapy, Neoadjuvant chemotherapy.
Who it may be relevant to
Registry conditions: Lung Cancer (NSCLC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Association Between Respiratory Tract and Gut Microbiome and the Efficacy and Safety of PD-1/PD-L1 Blockade in Resectable Non-small-cell Lung Cancer: a Single-center Cohort Study

Overview

This study will investigate the relationship between respiratory and gut microbiome and PD-1/PD-L1 immune checkpoint inhibitor efficacy and immune-related adverse events (irAE) in patients with non-small cell lung cancer (Stage IIA-IIIB）

Interventions

  • Drug Neoadjuvant immunotherapy combined with chemotherapy
    The treatment regimen consisted of a PD-1/PD-L1 monoclonal antibody in combination with a platinum-containing two-agent standard chemotherapy regimen administered every three weeks. Following two to four cycles of therapy, patients who demonstrated no evidence of disease progression were eligible for surgical resection, which was performed within three to four weeks after the conclusion of the last neoadjuvant therapy. Consolidation with a PD-1/PD-L1 monoclonal antibody was initiated within thre
  • Drug Neoadjuvant chemotherapy
    A platinum-containing two-agent standard chemotherapy regimen was administered every three weeks. Following a two-to-four-cycle therapy, if the patients were evaluated without progressive disease, patients undergo surgical resection within three to four weeks of the final neoadjuvant treatment. Postoperative adjuvant chemotherapy is then conducted in accordance with the recommended regimen outlined in the 2022 edition of the CSCO Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung

Primary outcome measures

  • Major pathological response (mPR) [Time frame: Whithin time from enrollment to surgery]
Secondary outcome measures (7)
  • Pathologic complete response (pCR) [Time frame: Whithin time from enrollment to surgery]
  • Disease free survival (DFS) [Time frame: Whithin 1 year after surgery]
  • Overall survival (OS) [Time frame: Whithin 1 year after enrollment]
  • Immune-related adverse event (irAE) [Time frame: Whithin 1 year after enrollment]
  • Changes in microbiomics in respiratory tract and gut [Time frame: Whithin 1 year after enrollment]
  • Radiological response [Time frame: Whithin time from enrollment to surgery]
  • Changes in single-cell immune repertoire [Time frame: Whithin time from enrollment to surgery]

Eligibility criteria

Inclusion criteria

  • 18-75 years old;
  • first-diagnosed, driver gene-negative non-small cell lung cancer patients with histopathological confirmed diagnosis (Stage IIA-IIIB);
  • at least 1 measurable lesion as defined by RECIST version 1.1; an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1;
  • no prior systemic therapy or radiotherapy;
  • the patients are eligible for indications for surgical resection and amenable to - neoadjuvant immunotherapy or chemotherapy after multidisciplinary evaluation;
  • signing the written consent before enrollment in the study;
  • participants need to have adequate pulmonary ventilation and diffusion function to allow surgical resection by pre-enrolment pulmonary function testing;

Exclusion criteria

  • refusal of participation or inability to give a clear consent;
  • requiring treatment with systemic glucocorticoids and other - immunosuppressive agents;
  • use of antibiotics within the previous 3 months or the presence of an infectious disease requiring antibiotic therapy;
  • probiotics within 3 months prior to enrolment;
  • presence of obstructive pneumonia, cancerous cavities, active tuberculosis;
  • the presence of bronchiectasis, combined lung infections, pulmonary fibrosis, uncontrolled diabetes mellitus;
  • the presence of primary tumors elsewhere;
  • receiving chemotherapy or any other cancer treatment prior to enrolment;
  • participants with brain metastases confirmed by brain MRI with contrast prior to enrolment;
  • active or pre-existing autoimmune disease;
  • the presence of uncontrolled comorbidities, including heart failure, uncontrolled hypertension, unstable angina, interstitial lung disease;
  • positive test for hepatitis B surface antigen or hepatitis C ribonucleic acid requiring treatment;
  • known positive history or positive test results for human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS);
  • history of allergy to study drug components;
  • women who are pregnant or breastfeeding;
  • previous treatment with anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibodies.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06613308 · 2022-YJXBF-03-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗