Correlation Between Specific Gene Mutationand Local Immune Microenvironment and Immunotherapy Efficacy in NSCLC
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2020
CompletedFirst Submitted
Initial submission to the registry
May 22, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedMay 28, 2020
May 1, 2020
1.1 years
May 22, 2020
May 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Correlation between specific gene mutation and immune microenvironment
Correlation between specific gene mutation and immune microenvironment
up to 1year
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
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 Outcomes (2)
Correlation of OS with specific gene mutation in immunotherapy of lung cancer
up to 1year
Correlation between immune microenvironment and OS in immunotherapy lung cancer patients
up to 1year
Eligibility Criteria
Chinese
You may qualify if:
- 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
You may not qualify if:
- History of other malignancies
- Cancer meningitis in subjects
- Incomplete clinical follow-up data
- Failure to sign informed consent to participate in the research program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Biospecimen
FFPE tissue and whole blood
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHD,Chief Physician
Study Record Dates
First Submitted
May 22, 2020
First Posted
May 28, 2020
Study Start
April 28, 2020
Primary Completion
May 31, 2021
Study Completion
May 30, 2022
Last Updated
May 28, 2020
Record last verified: 2020-05