Carcinoma, Non-Small-Cell Lung (NSCLC)FDG Immun CombNCT06833229
Prospective Cohort Study Evaluating 18FDG PET-CT for the Early Prediction of the Efficacy of Immunotherapy Associated or Not With Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Broncho-Pulmonary Carcinoma
An observational study of Carcinoma, Non-Small-Cell Lung (NSCLC), run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
The hypothesis of this prospective observational pilot study of diagnostic diagnostic performance is that, for patients with NSCLC treated with immunotherapy associated or not with chemotherapy, certain metabolic biomarkers on 18FDG PET scans allow early identification of treatment response (or lack of response to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung (NSCLC)
- What is being tested?
- FDG-PET
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2022to 27 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with locally advanced or metastatic NSCLC with an indication for immunotherapy combined with concomitant chemotherapy as standard treatment and managed at the Centre Antoine Lacassagne will be eligible.
Who may be able to join
- Age greater than or equal to 18 years,
- Patients with histologically proven, metastatic or locally advanced NSCLC, with indication for immunotherapy (Nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab), in combination or not with chemotherapy molecules (carboplatin, cisplatin, pemetrexed, paclitaxel or nab-paclitaxel), validated by a Multidisciplinary Team and prescribed within the scope of their Marketed Authorization, whatever the line of treatment treatment line,
- ECOG 0 to 3,
- The patient's understanding of the protocol and the note of non-opposition, with oral agreement,
- Patient has not objected to the use of his or her data for medical research. research,
- Patient has social security coverage.
Who cannot join
- Age under 18,
- Contraindication to 18FDG PET-CT examinations: severe claustrophobia, unbalanced diabetes at the time of the first PET-CT scan (fasting capillary glucose ≥ 11 mmol),
- Hemoglobin less than 7 g/dL at inclusion. If the patient has a respiratory or or cardiovascular pathology, hemoglobin must not be less than 9.0 g/dL,
- Any participation in other biomedical studies involving the drug, medical devices or medical devices or imaging techniques is prohibited, with the exception of biomedical studies,
- Refusal to participate in the present study,
- Contraindication (e.g. hypersensitivity to the active substance or to one of the excipients of immunotherapy or chemotherapy treatments...).
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- Vulnerable persons are defined in article L1121-5 to -8:
- Pregnant women, parturients and nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons hospitalized without consent under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of the provisions of article L. 1121-8,
- and persons admitted to a health or social establishment for purposes other than research purposes,
- adults who are the subject of a legal protection measure, or who are unable to exercise their non opposition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Antoine Lacassagne
Nice, 06189
Olivier HUMBERT, 0492031697 ext. +33, Olivier.HUMBERT@univ-cotedazur.fr
About this study
The hypothesis of this prospective observational pilot study of diagnostic diagnostic performance is that, for patients with NSCLC treated with immunotherapy associated or not with chemotherapy, certain metabolic biomarkers on 18FDG PET scans allow early identification of treatment response (or lack of response to treatment) and optimize prediction of tumor response compared with current standards.
- Conditions
- Carcinoma, Non-Small-Cell Lung (NSCLC)
- Being tested
- FDG-PET
- Medical subject headings
- Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PETProcedure or surgery
PET scan are performed within 28 days before the start of immunotherapy, then at week 6 and week 12 of follow-up. Various metabolic parameters extracted from the standard PET image (ΔSUVmax, ΔTLG, appearance of new visceral lesion(s)), parametric (metabolic glucose rate (Ki), volume of distribution (VD)) and tumor response based on PERCIST criteria (adapted to immunotherapy) are assessed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic criteria for PET imaging that can distinguish true tumor progression from pseudo-progression of inflammatory origin (leukocyte infiltrate)
Calculation of the area of the ROC curve and determination of the optimal threshold of different metabolic parameters extracted from the standard PET image (ΔSUVmax, ΔTLG, appearance of new visceral lesion(s)) and parametric PET image (metabolic glucose rate (Ki), volume of distribution (VD)) to distinguish lesions between true progression from inflammatory pseudoprogressions.
Measured: 36 months
Secondary outcomes (4)
Incidence of pseudo-progressions versus true tumor progressions at the first PET scan at 6 weeks.
Evaluation of the ratio between lesions with pseudo-inflammatory progression and those with true tumor progression (defined a posteriori on control PET-CT). A analysis per lesion and per patient. Two groups of patients will be compared: the group treated with immunotherapy alone and the group treated with a combination of immunotherapy and chemotherapy
Measured: 6 weeks
Prognostic value of metabolic response PET-CT at 6 weeks and 12 weeks on overall survival at 12, 24 and 36 months
Overall survival at 12, 24 and 36 months as a function of changes in tumor metabolism on the first interim PET-CT scans (PERCIST and ΔSUV analysis). Overall survival: time from date of inclusion to date of death from any cause.
Measured: 36 months
Use of supervised deep-learning algorithms (neural networks) to classify patients as immunotherapy responders or non-responders.
Non-responders will be defined as patients who discontinue immunotherapy within the first 6 months of treatment due to tumor progression. Responders will be defined by continuation of immunotherapy beyond 6 months of treatment.
Measured: 6 months
Evaluation of overall survival of patients with oligometastatic progression with maintenance of immunotherapy and targeted irradiation of progressing lesions.
Overall survival at 24 months as a function of whether or not irradiation (as part of standard practices) of progressing lesions in patients with metastatic oligo-progression on 18FDG PET (between 1 and 3 progressive lesions).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start27 Jan 2022
- Primary completion27 May 2028 (estimated)
- Study completion27 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell Lung (NSCLC)Studies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833229
- Sponsor's protocol ID
- 2021/11
- Other IDs
- 2021-A00352-39
- Acronym
- FDG Immun Comb
- Status last verified
- May 2026
- First submitted
- 13 Feb 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study Evaluating 18FDG PET-CT for the Early Prediction of the Efficacy of Immunotherapy Associated or Not With Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Broncho-Pulmonary Carcinoma
- ClinicalTrials.gov ID
- NCT06833229
- Acronym / sponsor ID
- FDG Immun Comb / 2021/11
- Conditions
- Carcinoma, Non-Small-Cell Lung (NSCLC)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 27 May 2028 (estimated)
- Study completion
- 27 Jan 2031 (estimated)
- First posted
- 18 Feb 2025 (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 hypothesis of this prospective observational pilot study of diagnostic diagnostic performance is that, for patients with NSCLC treated with immunotherapy associated or not with chemotherapy, certain metabolic biomarkers on 18FDG PET scans allow early identification of treatment response (or lack of response to treatment) and optimize prediction of tumor response compared with current standards.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with locally advanced or metastatic NSCLC with an indication for immunotherapy combined with concomitant chemotherapy as standard treatment and managed at the Centre Antoine Lacassagne will be eligible.
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years,
- Patients with histologically proven, metastatic or locally advanced NSCLC, with indication for immunotherapy (Nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab), in combination or not with chemotherapy molecules (carboplatin, cisplatin, pemetrexed, paclitaxel or nab-paclitaxel), validated by a Multidisciplinary Team and prescribed within the scope of their Marketed Authorization, whatever the line of treatment treatment line,
- ECOG 0 to 3,
- The patient's understanding of the protocol and the note of non-opposition, with oral agreement,
- Patient has not objected to the use of his or her data for medical research. research,
Key exclusion criteria (10 listed)
- Age under 18,
- Contraindication to 18FDG PET-CT examinations: severe claustrophobia, unbalanced diabetes at the time of the first PET-CT scan (fasting capillary glucose ≥ 11 mmol),
- Hemoglobin less than 7 g/dL at inclusion. If the patient has a respiratory or or cardiovascular pathology, hemoglobin must not be less than 9.0 g/dL,
- Any participation in other biomedical studies involving the drug, medical devices or medical devices or imaging techniques is prohibited, with the exception of biomedical studies,
- Refusal to participate in the present study,
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 |
|---|---|---|
| FDG-PETPET scan are performed within 28 days before the start of immunotherapy, then at week 6 and week 12 of follow-up. Various metabolic parameters extracted from the standard PET image (ΔSUVmax, ΔTLG, appearance of new visceral lesion(s)), parametric (metabolic glucose rate (Ki), volume of distribution (VD)) and tumor response based on PERCIST criteria (adapted to immunotherapy) are assessed. | Procedure or surgery | – |
Primary outcome
Metabolic criteria for PET imaging that can distinguish true tumor progression from pseudo-progression of inflammatory origin (leukocyte infiltrate)
Time frame: 36 months
Calculation of the area of the ROC curve and determination of the optimal threshold of different metabolic parameters extracted from the standard PET image (ΔSUVmax, ΔTLG, appearance of new visceral lesion(s)) and parametric PET image (metabolic glucose rate (Ki), volume of distribution (VD)) to distinguish lesions between true progression from inflammatory pseudoprogressions.
4 secondary outcomes
Incidence of pseudo-progressions versus true tumor progressions at the first PET scan at 6 weeks.
Time frame: 6 weeks
Prognostic value of metabolic response PET-CT at 6 weeks and 12 weeks on overall survival at 12, 24 and 36 months
Time frame: 36 months
Use of supervised deep-learning algorithms (neural networks) to classify patients as immunotherapy responders or non-responders.
Time frame: 6 months
Evaluation of overall survival of patients with oligometastatic progression with maintenance of immunotherapy and targeted irradiation of progressing lesions.
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Carcinoma, Non-Small-Cell Lung (NSCLC), run by Centre Antoine Lacassagne at 1 site 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 10 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: looking for participants now, as of the sponsor's last update on 29 May 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (04 92 03 14 76 ext. +33, DRCI-Promotion@nice.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic criteria for PET imaging that can distinguish true tumor progression from pseudo-progression of inflammatory origin (leukocyte infiltrate) (time frame: 36 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 29 May 2026.