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

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.