Non-Small Cell Lung Cancer
Conditions
Keywords
Multicenter Observational Study, Tumor Mutation Burden (TMB), immunotherapy, Pleural effusion
Brief summary
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
Method of Research: 1. 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×) 2. 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; 3. Collected Imaging(CT)and pathological data before treatment; 4. Immunotherapy was applied for 8 weeks to evaluate the efficacy; 5. 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. 6. The date of blood routine examination(neutrophils to lymphocytes ratio (NLR)) and serological tumor maker of NSCLC were collected after treatment; 7. Imaging, CT and pathological data of patients after treatment were collected
Interventions
OTHERNon-Intervention
Non-Intervention
Sponsors
Guangzhou Institute of Respiratory Disease
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. male or female,18 years ≤ age ≤80 years; 2. Pathologically confirmed stage ⅢB-Ⅳ NSCLC, which is not suitable for surgical resection; 3. No systematic anti-tumor treatment; 4. Pleural effusion ≥50ml,tissue samples can be obtained; 5. The driver gene was negative, and immunotherapy was proposed; 6. According to RECIST 1.1, at least one tumor lesion that can be measured or evaluated; 7. Signed and dated informed consent
Exclusion criteria
1. No pathological diagnosis or the diagnosis is not clear; 2. Severe pneumonia or tuberculosis; 3. Tumor tissues cannot be obtained; 4. Combine with other tumor type or other subtypes of lung cancer; 5. Poor compliance, unable to complete follow-up; 6. The investigator judges the situation that may affect the clinical search process and results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) of NSCLC patients with malignant pleural effusion who were received immunotherapy | 2021 | The relationship between tumor mutation burden and objective response rate in NSCLC patients |
| Progression-free survival (PFS) of NSCLC patients with malignant pleural effusion who were received immunotherapy | 2021 | The relationship between tumor mutation burden and progression-free survival in NSCLC patients |
| Overall survival (OS) of NSCLC patients with malignant pleural effusion who were received immunotherapy | 2022 | The relationship between tumor mutation burden and overall survival in NSCLC patients |
Contacts
Primary ContactChengzhi Zhou
Outcome results
None listed