Clinical trial NCT04263688: Multicenter Observational Study of Advanced Non-small Cell Lung Cancer With Malignant Pleural Effusion
Official title: Multicenter Observational Study for Correlation Between Tumor Mutation Burden and Immunotherapy Efficacy of Advanced Non-small Cell Lung Cancer With Malignant Pleural Effusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Small Cell Lung Cancer
Keywords: Multicenter Observational Study
Tumor Mutation Burden (TMB)
immunotherapy
Pleural effusion
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically or cytologically proven diagnosis of ⅢB-Ⅳ NSCLC

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

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate (ORR) of NSCLC patients with malignant pleural effusion who were received immunotherapy
timeFrame: 2021
measure: Progression-free survival (PFS) of NSCLC patients with malignant pleural effusion who were received immunotherapy
timeFrame: 2021
measure: Overall survival (OS) of NSCLC patients with malignant pleural effusion who were received immunotherapy
timeFrame: 2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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