Correlation Between Specific Gene Mutationand Local Immune Microenvironment and Immunotherapy Efficacy in NSCLC

NSCLC Clinical Trial

Official title:

Correlation Between Specific Gene Mutationand Local Immune Microenvironment and Immunotherapy Efficacy in NSCLC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04405661
• Other study ID #: NSCLC-202005
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

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