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

NCT ID: NCT04405661

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-28
• Study Completion Date: 2022-05-30

Brief 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.

Detailed 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.

Conditions

NSCLC

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GeneCast Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

Zhou Chengzhi

PHD,Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

chengzhi zhou, PHD

Role: CONTACT

doctorzcz@163.com

+8613560351186

Facility Contacts

Chengzhi Zhou, MD

Role: primary

doctorzcz@163.com

+8613560351186896

Other Identifiers

NSCLC-202005

Identifier Type: -

Identifier Source: org_study_id