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

Capital Medical University

Status

Not yet enrolling

Conditions

Lung Cancer (NSCLC)

Treatments

Drug: Neoadjuvant immunotherapy combined with chemotherapy

Drug: Neoadjuvant chemotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT06613308

2022-YJXBF-03-01

Details and patient eligibility

About

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）

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.