Multicenter Observational Study of Advanced Non-small Cell Lung Cancer With Malignant Pleural Effusion

Study Overview
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Brief Summary
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Multicenter observational study for correlation between tumor mutation burden and immunotherapy efficacy of advanced non-small cell lung cancer with malignant pleural effusion

Detailed Description
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Method of Research: ⅢB-Ⅳ NSCLC patients, tumor mutation burden (TMB) was tested by the 448 gene panel with pleural effusion and tissue sample, to observed mutation characteristics;Tissue and pleural effusion cell precipitation:TMB (Next generation sequencing, 448 gene panel;Average sequencing depth: above 5000×) The date of blood routine examination(neutrophils to lymphocytes ratio (NLR)) and serological tumor maker of NSCLC were collected before treatment;the The results of Programmed death ligand 1 (PDL1) expression level were collected also; Collected Imaging(CT)and pathological data before treatment; Immunotherapy was applied for 8 weeks to evaluate the efficacy; The tumor mutation burden of pleural effusion was tested again for the patients of hyper-progression after immunotherapy, the mutation characteristics and changes were observed, the molecular mutation change before and after treatment were evaluated, and the correlation with immunotherapy was analyzed.Hyper-progression (HPD) were defined as tumor growth rate excess of 50% compared to baseline CT scans prior to treatment initiation.The patient underwent imaging examination (chest CT or pet-ct) at 2 months (8 weeks) after 3 full doses of immunotherapy drugs. The date of blood routine examination(neutrophils to lymphocytes ratio (NLR)) and serological tumor maker of NSCLC were collected after treatment; Imaging, CT and pathological data of patients after treatment were collected

Official Title
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Multicenter Observational Study for Correlation Between Tumor Mutation Burden and Immunotherapy Efficacy of Advanced Non-small Cell Lung Cancer With Malignant Pleural Effusion

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Other: Non-Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female,18 years ≤ age ≤80 years; Pathologically confirmed stage ⅢB-Ⅳ NSCLC, which is not suitable for surgical resection; No systematic anti-tumor treatment; Pleural effusion ≥50ml,tissue samples can be obtained; The driver gene was negative, and immunotherapy was proposed; According to RECIST 1.1, at least one tumor lesion that can be measured or evaluated; Signed and dated informed consent Exclusion Criteria: No pathological diagnosis or the diagnosis is not clear; Severe pneumonia or tuberculosis; Tumor tissues cannot be obtained; Combine with other tumor type or other subtypes of lung cancer; Poor compliance, unable to complete follow-up; The investigator judges the situation that may affect the clinical search process and results

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immunotherapy effective<br>Immunotherapy was applied for 8 weeks to evaluate the efficacy，The efficacy of immunotherapy was evaluated by imaging, and was evaluated according to RECIST 1.1. | Other: Non-Intervention<br>* Non-Intervention<br>|
| Immunotherapy Ineffective<br>Immunotherapy was applied for 8 weeks to evaluate the efficacy，The efficacy of immunotherapy was evaluated by imaging, and was evaluated according to RECIST 1.1. | Other: Non-Intervention<br>* Non-Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) of NSCLC patients with malignant pleural effusion who were received immunotherapy | The relationship between tumor mutation burden and objective response rate in NSCLC patients | 2021 | 
| Progression-free survival (PFS) of NSCLC patients with malignant pleural effusion who were received immunotherapy | The relationship between tumor mutation burden and progression-free survival in NSCLC patients | 2021 | 
| Overall survival (OS) of NSCLC patients with malignant pleural effusion who were received immunotherapy | The relationship between tumor mutation burden and overall survival in NSCLC patients | 2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multicenter Observational Study, Tumor Mutation Burden (TMB), immunotherapy, Pleural effusion