NSCLCNCT04405661
Correlation Between Specific Gene Mutationand Local Immune Microenvironment and Immunotherapy Efficacy in NSCLC
An observational study of NSCLC, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NSCLC
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2020to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese
Who may be able to join
- 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
Who cannot join
- History of other malignancies
- Cancer meningitis in subjects
- Incomplete clinical follow-up data
- Failure to sign informed consent to participate in the research program
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Chengzhi Zhou, MD, +8613560351186896, doctorzcz@163.com
Chengzhi Zhou, MD
About this study
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.
Read the 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
- Keywords
- PD-L1, NSCLC, Biomarker, mIHC, immune microenvironment, mutation, sequencing
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between specific gene mutation and immune microenvironment
Correlation between specific gene mutation and immune microenvironment
Measured: 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
Measured: 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
Measured: up to 1year
Secondary outcomes (2)
Correlation of OS with specific gene mutation in immunotherapy of lung cancer
Correlation of OS with specific gene mutation in immunotherapy of lung cancer
Measured: up to 1year
Correlation between immune microenvironment and OS in immunotherapy lung cancer patients
Correlation between immune microenvironment and OS in immunotherapy lung cancer patients
Measured: up to 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start28 Apr 2020
- Primary completion31 May 2021 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Collaborators
- GeneCast Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405661
- Sponsor's protocol ID
- NSCLC-202005
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Specific Gene Mutationand Local Immune Microenvironment and Immunotherapy Efficacy in NSCLC
- ClinicalTrials.gov ID
- NCT04405661
- Acronym / sponsor ID
- NSCLC-202005
- Conditions
- NSCLC
- Keywords
- PD-L1, NSCLC, Biomarker, mIHC, immune microenvironment, mutation, sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Collaborators
- GeneCast Biotechnology Co., Ltd.
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- History of other malignancies
- Cancer meningitis in subjects
- Incomplete clinical follow-up data
- Failure to sign informed consent to participate in the research program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between specific gene mutation and immune microenvironment
Time frame: up to 1year
Correlation between specific gene mutation and immune microenvironment
Correlation between specific gene mutations and ORR and PFS in immunotherapy patients with lung cancerof lung cancer patients with immunotherapy
Time frame: up to 1year
Correlation between specific gene mutations and ORR and PFS in immunotherapy patients with lung cancer
Correlation between immune microenvironment and ORR and PFS in immunotherapy lung cancer patients
Time frame: up to 1year
Correlation between immune microenvironment and ORR and PFS in immunotherapy lung cancer patients
2 secondary outcomes
Correlation of OS with specific gene mutation in immunotherapy of lung cancer
Time frame: up to 1year
Correlation between immune microenvironment and OS in immunotherapy lung cancer patients
Time frame: up to 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chengzhi zhou, PHD (+8613560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between specific gene mutation and immune microenvironment (time frame: up to 1year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.