NSCLC Stage IVNCT05533086
PD-L1 PET Imaging in Patients With the Immunotherapy for Non-small Cell Lung Cancer
An observational study of NSCLC Stage IV and PD-L1 Gene Amplification, run by Xiaohua Zhu at 1 site in China.
Trial summary
Clinical trials have shown efficacy of PD1/PD-L1 checkpoint inhibitors in multiple solid tumors, including NSCLC. Whole body information with regard to target presence, drug kinetics and dynamics, as well as binding of PD-L1 targeting agents to the immune system cells is lacking.Molecular imaging of PD-L1 could lead… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage IV, PD-L1 Gene Amplification
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2022to 31 Aug 2025
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients should be diagnosed with stage IV non-small cell lung cancer. Patients should be eligible for treatment withanti-PD-1/PD-L1 therapy. Patients participating in other trials with this agent may participate in phase one of this study, as long as this does not interfere with either one of the study protocols.
Who may be able to join
- (1) Subjects must be diagnosed with histologically confirmed stage IV non-small cell lung cancer and >18 years of age with driver mutations (-).
- Planned for anti-PD-1/PD-L1 therapy. (3) At least one easy accessible lesion of which a biopsy can be taken within one month prior to PET scan.
- Subjects must sign informed consent prior to inclusion in this trial.
Who cannot join
- (1) Female patients during pregnancy and lactation. (2) Patients with psychiatric disease, severe hepatic and renal insufficiency. (3) Patients who refuse anti-PD-1/PD-L1 therapy. (4) Patients who are claustrophobic or unable to undergo PET/CT examination. (5) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways, except anti-CTLA4 antibody.
- Those who, in the opinion of the investigator, are otherwise unsuitable for clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
TongjiHospital
Wuhan, Hubei, 430030
xiaohua zhu, Dr., 13971513770 ext. 86, evazhu@vip.sina.com
About this study
Clinical trials have shown efficacy of PD1/PD-L1 checkpoint inhibitors in multiple solid tumors, including NSCLC. Whole body information with regard to target presence, drug kinetics and dynamics, as well as binding of PD-L1 targeting agents to the immune system cells is lacking.Molecular imaging of PD-L1 could lead to new insights on heterogeneity of PD-L1 expression in metastatic lesions and be of help in the prediction of response to PD1/PD-L1 inhibitors in a noninvasive manner.
Read the detailed description
Immunohistochemistry (IHC) is currently the most commonly used method for evaluation of PD-L1 status in cancer patients,including NSCLC. However, biopsies are spatiotemporally limited because of the highly heterogeneous expression of PD-L1. Only 20-40% of PD-L1-positive patients respond to treatment, while 10% of PD-L1-negative patients show a good response to immune checkpoint inhibitors .Patients with false-negative PD-L1 results may miss the chance for targeted therapy.Additionally, the PD-L1 status can change dynamically during the disease process.Therefore, it is necessary to achieve higher response rates, lower toxicity and lower treatment costs by finding assays to better assess PD-L1 expression and screen patients for benefit.
PD-L1 PET imaging provides a new approach to assess PD-L1 expression in NSCLC patients and is expected to overcome the limitations of immunohistochemical ,detection of PD-L1 expression for dynamic visualization in primary and metastatic tumors . First, PET imaging can provide multidimensional three-dimensional data of overall PD-L1 expression in tumors. Second, the whole-body PD-L1 expression level can be assessed, and the heterogeneity of PD-L1 expression between tumors can be studied simultaneously. Third, it is non-invasive and provides information on PD-L1 expression not only before treatment, but also allows monitoring PD-L1 expression several times during treatment ,to screen patients for benefit and guide treatment.
Currently, the FDA-approved 68Ga/68Gagenerator is commercially available, and the cyclotron can produce 68Ga on a large scale. Also, the 68Ga labeling technology is mature. Therefore, 68Ga-PDL1 PET imaging is more easily translatable to the clinical setting. A previous study reported the synthesis and preclinical evaluation of 68Ga-BMS986192, including PD-L1 affinity, metabolic stability, micro PET imaging and in vivo biodistribution in PD-L1 positive and negative transplanted tumors, demonstrating the feasibility of this tracer for in vivo imaging of tumor PD-L1 expression.
- Conditions
- NSCLC Stage IV, PD-L1 Gene Amplification
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax
SUVmax
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start16 Aug 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xiaohua Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaohua Zhu, Tongji Hospital
- Investigators
- ZHU XIAOHUA, DR, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533086
- Sponsor's protocol ID
- TJ-IRB20220816
- Status last verified
- Feb 2023
- First submitted
- 6 Sep 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-L1 PET Imaging in Patients With the Immunotherapy for Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05533086
- Acronym / sponsor ID
- TJ-IRB20220816
- Conditions
- NSCLC Stage IV, PD-L1 Gene Amplification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xiaohua ZhuUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 8 Sep 2022 (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.
Clinical trials have shown efficacy of PD1/PD-L1 checkpoint inhibitors in multiple solid tumors, including NSCLC. Whole body information with regard to target presence, drug kinetics and dynamics, as well as binding of PD-L1 targeting agents to the immune system cells is lacking.Molecular imaging of PD-L1 could lead to new insights on heterogeneity of PD-L1 expression in metastatic lesions and be of help in the prediction of response to PD1/PD-L1 inhibitors in a noninvasive manner.
Detailed description
Immunohistochemistry (IHC) is currently the most commonly used method for evaluation of PD-L1 status in cancer patients,including NSCLC. However, biopsies are spatiotemporally limited because of the highly heterogeneous expression of PD-L1. Only 20-40% of PD-L1-positive patients respond to treatment, while 10% of PD-L1-negative patients show a good response to immune checkpoint inhibitors .Patients with false-negative PD-L1 results may miss the chance for targeted therapy.Additionally, the PD-L1 status can change dynamically during the disease process.Therefore, it is necessary to achieve higher response rates, lower toxicity and lower treatment costs by finding assays to better assess PD-L1 expression and screen patients for benefit.
PD-L1 PET imaging provides a new approach to assess PD-L1 expression in NSCLC patients and is expected to overcome the limitations of immunohistochemical ,detection of PD-L1 expression for dynamic visualization in primary and metastatic tumors . First, PET imaging can provide multidimensional three-dimensional data of overall PD-L1 expression in tumors. Second, the whole-body PD-L1 expression level can be assessed, and the heterogeneity of PD-L1 expression between tumors can be studied simultaneously. Third, it is non-invasive and provides information on PD-L1 expression not only before treatment, but also allows monitoring PD-L1 expression several times during treatment ,to screen patients for benefit and guide treatment.
Currently, the FDA-approved 68Ga/68Gagenerator is commercially available, and the cyclotron can produce 68Ga on a large scale. Also, the 68Ga labeling technology is mature. Therefore, 68Ga-PDL1 PET imaging is more easily translatable to the clinical setting. A previous study reported the synthesis and preclinical evaluation of 68Ga-BMS986192, including PD-L1 affinity, metabolic stability, micro PET imaging and in vivo biodistribution in PD-L1 positive and negative transplanted tumors, demonstrating the feasibility of this tracer for in vivo imaging of tumor PD-L1 expression.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients should be diagnosed with stage IV non-small cell lung cancer. Patients should be eligible for treatment withanti-PD-1/PD-L1 therapy. Patients participating in other trials with this agent may participate in phase one of this study, as long as this does not interfere with either one of the study protocols.
Key inclusion criteria (3 listed)
- (1) Subjects must be diagnosed with histologically confirmed stage IV non-small cell lung cancer and >18 years of age with driver mutations (-).
Key exclusion criteria (2 listed)
- (1) Female patients during pregnancy and lactation. (2) Patients with psychiatric disease, severe hepatic and renal insufficiency. (3) Patients who refuse anti-PD-1/PD-L1 therapy. (4) Patients who are claustrophobic or unable to undergo PET/CT examination. (5) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways, except anti-CTLA4 antibody.
- Those who, in the opinion of the investigator, are otherwise unsuitable for clinical trials.
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
SUVmax
Time frame: 1 year
SUVmax
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
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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.
ZHU XIAOHUA, DR principal investigator
Tongji Hospital
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 Stage IV and PD-L1 Gene Amplification, run by Xiaohua Zhu 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 2 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 13 Feb 2023. 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 ZHU XIAOHUA, DR (13971513770 ext. 18012908238, evazhu@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax (time frame: 1 year). 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 13 Feb 2023.