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| Name | Class |
|---|---|
| China-Japan Friendship Hospital | OTHER |
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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）
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1(Neoadjuvant immunotherapy combined with chemotherapy) |
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| Arm2(Neoadjuvant chemotherapy) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant immunotherapy combined with chemotherapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Whithin time from enrollment to surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yeming Wang, M.D. | Contact | +86 84206264 | wwyymm_love@163.com | |
| Dong Liu, M.D. | Contact | liudongdoc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| science and technology center | China-Japan Friendship Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
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Microbiome in faeces, sputum, swabs, BALF, surgically resected lung lesions
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| Neoadjuvant chemotherapy | Drug | 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. |
|
| 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. | Whithin 1 year after surgery |
| Overall survival (OS) | defined as time from enrolment to all-cause death | 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. | 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 | Whithin 1 year after enrollment |
| Radiological response | Defined as radiographic change assesed by RECIST 1.1. | 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 | Whithin time from enrollment to surgery |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |