Clinical trial NCT06613308: Association Between Microbiome and the Efficacy and Safety of PD-1/PD-L1 Blockade in Resectable NSCLC
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer (NSCLC)
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
First posted: 2024-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The neoadjuvant cohort of patients with non-small cell lung cancer (NSCLC) (stages IIA to selective stage IIIB; squamous or non-squamous cell) who are receiving a PD-1/PD-L1 monoclonal antibody in conjunction with platinum-containing two-agent standard chemotherapy (Arm 1) or platinum-containing two-agent standard chemotherapy (Arm 2).

Brief summary: 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）


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.

Primary outcomes:
measure: Major pathological response (mPR)
timeFrame: Whithin time from enrollment to surgery
Secondary outcomes:
measure: Pathologic complete response (pCR)
timeFrame: Whithin time from enrollment to surgery
measure: Disease free survival (DFS)
timeFrame: Whithin 1 year after surgery
measure: Overall survival (OS)
timeFrame: Whithin 1 year after enrollment
measure: Immune-related adverse event (irAE)
timeFrame: Whithin 1 year after enrollment
measure: Changes in microbiomics in respiratory tract and gut
timeFrame: Whithin 1 year after enrollment
measure: Radiological response
timeFrame: Whithin time from enrollment to surgery
measure: Changes in single-cell immune repertoire
timeFrame: Whithin time from enrollment to surgery
Other outcomes:
Locations:
Study officials:
affiliation: China-Japan Friendship Hospital
name: science and technology center
role: PRINCIPAL_INVESTIGATOR
References: