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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04405661
Other study ID # NSCLC-202005
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 28, 2020
Est. completion date May 30, 2022

Study information

Verified date May 2020
Source Guangzhou Institute of Respiratory Disease
Contact chengzhi zhou, PHD
Phone +8613560351186
Email doctorzcz@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Immunotherapy for PD-L1 positive patients is still ineffective in some patients,which may be related to the complex immune microenvironment.In view of this bottleneck, further refinement of immunotyping and in-depth study of drug resistance mechanism are the most important tasks. In this observational study, we evaluated the difference of gene mutation and immune microenvironment and therapeutic effect in primary NSCLC.


Description:

There are still some patients with PD-L1 positive who are ineffective in immunotherapy, which may be related to the complex immune microenvironment. In view of this bottleneck, further refinement of immunotyping and in-depth study of drug resistance mechanism are the most important tasks.

Recently, studies have shown that the core elements of tumor microenvironment that have a significant impact on immunotherapy are:1. Infiltration abundance of specific killer T cells; 2. PD-L1 expression dependent on IFN - γ pathway, down-regulation of various active molecules and up-regulation of inhibitory molecules; 3. Activation and clearance of various inhibitory T cells.

Although the classification has achieved further refinement of immune cells and molecular level, there are still some problems to be solved urgently: first, the classification of TIL cells needs further refinement, and different types of TIL infiltration have different guiding significance for prognosis; second, the subjective second-order semi quantitative scoring is often used for til count scoring, with low repeatability and different centers It is not easy for different pathologists to reach an agreement on the results of reading and interpretation. Thirdly, conventional methods are difficult to meet the requirements of tumor microenvironment analysis. In conclusion, it is urgent to develop a multi molecular marker landscape analysis system for tumor microenvironment, and establish a standardized detection process for each molecule to meet the needs of clinical positioning, quantitative and qualitative analysis for key molecular markers of immune microenvironment.

In this observational study, we evaluated the difference of gene mutation and immune microenvironment and therapeutic effect in primary NSCLC.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 30, 2022
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Non small cell lung cancer was diagnosed by cytology or histopathology;

- Patients to be treated with PD-1 / PD-L1 inhibitors;

- Who signed the informed consent for participating in the research plan

Exclusion Criteria:

- History of other malignancies

- Cancer meningitis in subjects

- Incomplete clinical follow-up data

- Failure to sign informed consent to participate in the research program

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Guangzhou Institute of Respiratory Disease GeneCast Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between specific gene mutation and immune microenvironment Correlation between specific gene mutation and immune microenvironment up to 1year
Primary Correlation between specific gene mutations and ORR and PFS in immunotherapy patients with lung cancerof lung cancer patients with immunotherapy Correlation between specific gene mutations and ORR and PFS in immunotherapy patients with lung cancer up to 1year
Primary Correlation between immune microenvironment and ORR and PFS in immunotherapy lung cancer patients Correlation between immune microenvironment and ORR and PFS in immunotherapy lung cancer patients up to 1year
Secondary Correlation of OS with specific gene mutation in immunotherapy of lung cancer Correlation of OS with specific gene mutation in immunotherapy of lung cancer up to 1year
Secondary Correlation between immune microenvironment and OS in immunotherapy lung cancer patients Correlation between immune microenvironment and OS in immunotherapy lung cancer patients up to 1year
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