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）
Study Type
OBSERVATIONAL
Enrollment
20
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 three to eight weeks after surgery and continued every three weeks. The efficacy of the treatment was evaluated according to the irRECIST criteria. Chemotherapy regimens were selected based on tumour histology and investigator judgement. In the event of poor tolerability, patients may switch between cisplatin or carboplatin treatments.
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 Cancer. The efficacy of the treatment was evaluated in accordance with the RECIST 1.1 criteria. The chemotherapy regimens were selected based on the tumor histology and the judgement of the investigators, in accordance with the standard clinical practice. In the event of poor tolerability, patients may switch between cisplatin or carboplatin treatments.
Major pathological response (mPR)
defined as ≤10% residual live tumor tissue in lung cancer samples resected after neoadjuvant therapy as assessed by the central pathology laboratory.
Time frame: Whithin time from enrollment to surgery
Pathologic complete response (pCR)
defined as the absence of live tumour cells in lung cancer specimens resected after neoadjuvant therapy and in all sampled local lymph nodes according to central pathology laboratory assessment. Patients who are not evaluable according to the central pathological assessment (including patients with R2 margins) or who do not have a surgical specimen will not be considered to have achieved a pCR (e.g. remission will be recorded as 'not evaluable' or 'missing', as appropriate).
Time frame: Whithin time from enrollment to surgery
Disease free survival (DFS)
defined as the time from surgery to the first recurrence of disease (local or distant) or all-cause death, whichever occurs first. DFS was captured only for events after surgery.
Time frame: Whithin 1 year after surgery
Overall survival (OS)
defined as time from enrolment to all-cause death
Time frame: Whithin 1 year after enrollment
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: Whithin 1 year after enrollment
Changes in microbiomics in respiratory tract and gut
Defined as microbial composition, diversity, and functional activity measured by 16S RNA sequencing
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Time frame: Whithin 1 year after enrollment
Radiological response
Defined as radiographic change assesed by RECIST 1.1.
Time frame: Whithin time from enrollment to surgery
Changes in single-cell immune repertoire
Defined as diversity of immune receptors (e.g. TCR and BCR) for T and B cells in lung tissues
Time frame: Whithin time from enrollment to surgery