Non Small Cell Lung CanceriTEP1NCT03832348
Dynamics of 18-FDG Uptake in Stage III/IV Non Small Cell Lung Cancer During First Line Pembrolizumab Treatment
A study testing PET scan imaging in people with Non Small Cell Lung Cancer, run by Centre Henri Becquerel at 2 sites in France.
Trial summary
The aim of this study is to describe the early dynamics of 18-FDG uptake in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response at 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- PET scan imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Jun 2019to 3 Jul 2024
- 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
- Non operable non small cell lung cancer
- Indication of treatment by Pembrolizumab
- PD-L1 status superior to 50 %
- Age more than 18 years
- At least one measurable target
- Written inform consent
Who cannot join
- no treatment by pembrolizumab
- immunosuppressive treatment
- uncontrolled diabete
- Pregnancy or breast-feeding
- curatorship or guardianship
- not possibility to follow-up the procedures of the study due to geographic, social or psychic reasons
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 18-FDG Tumour Metabolism Changes in PDL1 Superior to 50% Stage III/IV Non Small Cell Lung Cancer During First Line Treatment With Pembrolizumab
The aim of this study is to describe the early dynamics of 18-FDG uptake in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response at 3 months.
Read the detailed description
Immunotherapy with anti-PD1 antibody, such as Pembrolizumab, is widely used in the treatment of stage III/IV non small cell lung cancer. In order to refine treatments and patients' prognosis, early assessment of tumour response is needed.
The aim of this study is to describe the early tumour metabolic changes in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response.
Eligible patients with stage III/IV, PDL1>50% NSCLC will receive pembrolizumab treatment as per standard of care.
Tumour metabolism will be assessed by 18-FDG PETscan before each of the 3 first pembrolizumab infusions. Treatment response will be determined by RECIST, irRC and mCHOI criteria at 3 months.
Prognostic and predictive value of baseline and dynamic metabolic parameters will be assessed.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- PET scan imaging
- Keywords
- PET scan imaging, Pembrolizumab, Response, Parametric imaging
- 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.
PET scan imagingDevice
3 PET scans will be performed after each 3 first infusions of Pembrolizumab
| Study group | Role | What they receive |
|---|---|---|
| PET scan imaging | Experimental | PET scan will be performed each of three first cycles of pembrolizumab to describe the early tumour metabolic changes during the first line of treatment. Receives: Device: PET scan imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of progression by early PET scan
Determination of non-response of treatment by PET scan imaging after one cycle of Pembrolizumab
Measured: 3 months
Secondary outcomes (2)
Progression free survival
Time between inclusion and progression
Measured: 24 months
Overall survival
Time between inclusion and death
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start17 Jun 2019
- Primary completion3 Jun 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Becker, MD, Principal investigator, Centre Henri BecquerelFlorian Guisier, MD, Principal investigator, CHU Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832348
- Sponsor's protocol ID
- CHB18.05
- Acronym
- iTEP1
- Status last verified
- Dec 2025
- First submitted
- 5 Feb 2019
- Last updated
- 2 Jan 2026
- 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18-FDG Tumour Metabolism Changes in PDL1 Superior to 50% Stage III/IV Non Small Cell Lung Cancer During First Line Treatment With Pembrolizumab
- ClinicalTrials.gov ID
- NCT03832348
- Acronym / sponsor ID
- iTEP1 / CHB18.05
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- PET scan imaging, Pembrolizumab, Response, Parametric imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 6 Feb 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.
The aim of this study is to describe the early dynamics of 18-FDG uptake in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response at 3 months.
Detailed description
Immunotherapy with anti-PD1 antibody, such as Pembrolizumab, is widely used in the treatment of stage III/IV non small cell lung cancer. In order to refine treatments and patients' prognosis, early assessment of tumour response is needed.
The aim of this study is to describe the early tumour metabolic changes in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response.
Eligible patients with stage III/IV, PDL1>50% NSCLC will receive pembrolizumab treatment as per standard of care.
Tumour metabolism will be assessed by 18-FDG PETscan before each of the 3 first pembrolizumab infusions. Treatment response will be determined by RECIST, irRC and mCHOI criteria at 3 months.
Prognostic and predictive value of baseline and dynamic metabolic parameters will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET scan imaging | Experimental | Device: PET scan imagingPET scan will be performed each of three first cycles of pembrolizumab to describe the early tumour metabolic changes during the first line of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non operable non small cell lung cancer
- Indication of treatment by Pembrolizumab
- PD-L1 status superior to 50 %
- Age more than 18 years
- At least one measurable target
Key exclusion criteria (6 listed)
- no treatment by pembrolizumab
- immunosuppressive treatment
- uncontrolled diabete
- Pregnancy or breast-feeding
- curatorship or guardianship
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 |
|---|---|---|
| PET scan imaging3 PET scans will be performed after each 3 first infusions of Pembrolizumab | Device | PET scan imaging |
Primary outcome
Determination of progression by early PET scan
Time frame: 3 months
Determination of non-response of treatment by PET scan imaging after one cycle of Pembrolizumab
2 secondary outcomes
Progression free survival
Time frame: 24 months
Overall survival
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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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.
Stephanie Becker, MD principal investigator
Centre Henri Becquerel
Florian Guisier, MD principal investigator
CHU Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET scan imaging in people with Non Small Cell Lung Cancer, run by Centre Henri Becquerel at 2 sites in France.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 2 Jan 2026. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determination of progression by early PET scan (time frame: 3 months). 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 2 Jan 2026.