NSCLC, Stage IVNCT04082988
Early Response Evaluation in NSCLC Patients Treated With Immunotherapy
A study testing 18F-FDG PET-CT in people with NSCLC, Stage IV, run by The Netherlands Cancer Institute at 2 sites in Netherlands.
Trial summary
A pilot study with biomarker exploration.50 patients with stage IV non-small cell lung cancer (NSCLC) that are eligible for treatment with nivolumab. Patients will undergo a 18F-FDG-PET/CT and EBUS-FNA of the lymph nodes and have blood drawn before and after immune checkpoint inhibitor treatment to compare tumor FDG… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Stage IV
- What is being tested?
- 18F-FDG PET-CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesNetherlands
- Study dates
- 23 Jan 2018to 22 May 2020
- Phase
- Interventional
- 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
Who may be able to join
- willing and able to provide written informed consent for the study.
- ≥ 18 years of age on day of signing informed consent.
- confirmed diagnosis of NSCLC.
- Histological tumor biopsy for PD-L1 IHC assessment (DAKO assay) available.
- Ipsilateral hilar or mediastinal lymph node with a short axis diameter ≥1 cm.
- Eligible and planned to receive nivolumab according to EMA label and national guidelines.
- Measurable disease according to RECIST v1.1.
- WHO performance status of 0-2.
Who cannot join
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to baseline PET-scan.
- Has an active infection or had an active infection within 2 weeks prior to baseline PET-scan.
- Has a known history of hypersensitivity to contrast material.
- Isolated distant relapse after curative intent treatment for stage I-III NSCLC.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
VU medical center
Amsterdam, 1007 MD
Leiden University Medical Center
Leiden, 2333 ZA
About this study
Official title: Early Response Evaluation With 18F-FDG PET/CT and Immunological Profiling of Circulating Immune Cells and Tumor-draining Lymph Nodes in Non-small Cell Lung Cancer Patients Treated With Immunotherapy.
A pilot study with biomarker exploration.50 patients with stage IV non-small cell lung cancer (NSCLC) that are eligible for treatment with nivolumab. Patients will undergo a 18F-FDG-PET/CT and EBUS-FNA of the lymph nodes and have blood drawn before and after immune checkpoint inhibitor treatment to compare tumor FDG uptake and to identify changes in the immune effector cell subsets in TDLNs. Blood will be drawn in parallel to compare the distribution of immune effector cell subsets before and after treatment initiation. Because of the possible burden for patients, the EBUS-FNA is not mandatory to complete the study and is there for an exploratory objective. Also blood will be drawn for a tumor mutational burden at baseline. The first six patients will undergo a dynamic PET-CT scan in addition to a static scan to study the influence of possible immunotherapy induced changes to the body distribution and kinetics of FDG..
Read the detailed description
Early response evaluation with 18F-FDG PET/CT and immunological profiling of circulating immune cells and tumor-draining lymph nodes in non-small cell lung cancer patients treated with immunotherapy.
- Conditions
- NSCLC, Stage IV
- Being tested
- 18F-FDG PET-CT
- Keywords
- PD-L1 expression, eligible for treatment with nivolumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET-CTDiagnostic test
Also called Tracer
18F-FDG PET-CT scan
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Other | Nivolumab treatment according to label: 3 mg/kg nivolumab IV Q2W, 240mg Q2W or 480mg Q4W as an IV infusion until disease progression or unacceptable toxicity.
FDG PET-CT will be performed at baseline and between 7 and 14 days after treatment initiation Receives: Diagnostic Test: 18F-FDG PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of collected immune cells by FNA EBUS will be assesed using flow cytometry.
The change in the percentages of selected immune cell parameters (CD4+ T, CD8+ T cells) after immunotherapy treatment as compared to baseline will be calculated
Measured: Baseline and at the end of cycle 1 (each cycle is 14 days).
Percentage of collected immune cells by FNA EBUS will be assesed using flow cytometry.
The change in the percentages of selected immune cell parameters (CD8+ T cells) after immunotherapy treatment as compared to baseline will be calculated
Measured: Baseline and at the end of cycle 1 (each cycle is 14 days).
FDG PET-CT analysis
Parameter change (SUVpeak) between both scans will be measured.
Measured: Baseline and at the end of cycle 1 (each cycle is 14 days).
FDG PET-CT analysis
Parameter change (SUVmax) between both scans will be measured.
Measured: Baseline and at the end of cycle 1 (each cycle is 14 days).
FDG PET-CT analysis
Parameter change (SUVmean) between both scans will be measured.
Measured: Baseline and at the end of cycle 1 (each cycle is 14 days).
Peripheral blood mononuclear cells will be isolated and counted using FACS
PBMC's will be counted at two timepoints. Change between both timepoints will be assessed.
Measured: Baseline and at the end of cycle 1 (each cycle is 14 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start23 Jan 2018
- Primary completion22 May 2020
- Study completion22 May 2020
Why it stopped: The study has been closed due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLC, Stage IVStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- J de Langen, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082988
- Sponsor's protocol ID
- M17IPL
- Status last verified
- Oct 2023
- First submitted
- 9 Nov 2018
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to be decided
Publications
Borm FJ, Smit J, Bakker J, Wondergem M, Smit EF, de Langen AJ, de Gruijl TD. Early response evaluation of PD-1 blockade in NSCLC patients through FDG-PET-CT and T cell profiling of tumor-draining lymph nodes. Oncoimmunology. 2023 Apr 26;12(1):2204745. doi: 10.1080/2162402X.2023.2204745. eCollection 2023.
PubMed 37123045
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Response Evaluation With 18F-FDG PET/CT and Immunological Profiling of Circulating Immune Cells and Tumor-draining Lymph Nodes in Non-small Cell Lung Cancer Patients Treated With Immunotherapy.
- ClinicalTrials.gov ID
- NCT04082988
- Acronym / sponsor ID
- M17IPL
- Conditions
- NSCLC, Stage IV
- Keywords
- PD-L1 expression, eligible for treatment with nivolumab
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been closed due to slow enrollment.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 10 Sep 2019 (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.
A pilot study with biomarker exploration.50 patients with stage IV non-small cell lung cancer (NSCLC) that are eligible for treatment with nivolumab. Patients will undergo a 18F-FDG-PET/CT and EBUS-FNA of the lymph nodes and have blood drawn before and after immune checkpoint inhibitor treatment to compare tumor FDG uptake and to identify changes in the immune effector cell subsets in TDLNs. Blood will be drawn in parallel to compare the distribution of immune effector cell subsets before and after treatment initiation. Because of the possible burden for patients, the EBUS-FNA is not mandatory to complete the study and is there for an exploratory objective. Also blood will be drawn for a tumor mutational burden at baseline. The first six patients will undergo a dynamic PET-CT scan in addition to a static scan to study the influence of possible immunotherapy induced changes to the body distribution and kinetics of FDG..
Detailed description
Early response evaluation with 18F-FDG PET/CT and immunological profiling of circulating immune cells and tumor-draining lymph nodes in non-small cell lung cancer patients treated with immunotherapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab | Other | Diagnostic Test: 18F-FDG PET-CTNivolumab treatment according to label: 3 mg/kg nivolumab IV Q2W, 240mg Q2W or 480mg Q4W as an IV infusion until disease progression or unacceptable toxicity. FDG PET-CT will be performed at baseline and between 7 and 14 days after treatment initiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- willing and able to provide written informed consent for the study.
- ≥ 18 years of age on day of signing informed consent.
- confirmed diagnosis of NSCLC.
- Histological tumor biopsy for PD-L1 IHC assessment (DAKO assay) available.
- Ipsilateral hilar or mediastinal lymph node with a short axis diameter ≥1 cm.
Key exclusion criteria (4 listed)
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to baseline PET-scan.
- Has an active infection or had an active infection within 2 weeks prior to baseline PET-scan.
- Has a known history of hypersensitivity to contrast material.
- Isolated distant relapse after curative intent treatment for stage I-III NSCLC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG PET-CTAlso: Tracer18F-FDG PET-CT scan | Diagnostic test | Nivolumab |
Primary outcome
Percentage of collected immune cells by FNA EBUS will be assesed using flow cytometry.
Time frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
The change in the percentages of selected immune cell parameters (CD4+ T, CD8+ T cells) after immunotherapy treatment as compared to baseline will be calculated
Percentage of collected immune cells by FNA EBUS will be assesed using flow cytometry.
Time frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
The change in the percentages of selected immune cell parameters (CD8+ T cells) after immunotherapy treatment as compared to baseline will be calculated
FDG PET-CT analysis
Time frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
Parameter change (SUVpeak) between both scans will be measured.
FDG PET-CT analysis
Time frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
Parameter change (SUVmax) between both scans will be measured.
FDG PET-CT analysis
Time frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
Parameter change (SUVmean) between both scans will be measured.
Peripheral blood mononuclear cells will be isolated and counted using FACS
Time frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
PBMC's will be counted at two timepoints. Change between both timepoints will be assessed.
Results and safety
The study was stopped early (reason given: The study has been closed due to slow enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 37123045Borm FJ, Smit J, Bakker J, Wondergem M, Smit EF, de Langen AJ, de Gruijl TD. Early response evaluation of PD-1 blockade in NSCLC patients through FDG-PET-CT and T cell profiling of tumor-draining lymph nodes. Oncoimmunology. 2023 Apr 26;12(1):2204745. doi: 10.1080/2162402X.2023.2204745. eCollection 2023.
- Individual participant dataSharing planned: Undecided. to be decided
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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.
J de Langen, MD, PhD principal investigator
The Netherlands Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG PET-CT in people with NSCLC, Stage IV, run by The Netherlands Cancer Institute at 2 sites in Netherlands.
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 8 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: stopped early, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
The study was stopped early (reason given: The study has been closed due to slow enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of collected immune cells by FNA EBUS will be assesed using flow cytometry. (time frame: Baseline and at the end of cycle 1 (each cycle is 14 days).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082988, which also lists 1 linked publication.
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 10 Oct 2023.