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

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Other: Non-Intervention

• Registration Number: NCT04263688
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-07
• Last Update Submitted: 2020-02-10
• Study First Posted: 2020-02-11
• Last Update Posted: 2020-02-12
• Study Start: 2020-03-01
• Primary Completion: 2021-03-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immunotherapy effective	Non-Intervention	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.
Immunotherapy Ineffective	Non-Intervention	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.

Primary Outcome Measures

Name	Time	Method
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
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
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