Small Cell Lung Carcinoma (SCLC)Early Phase 1PASSIFLORENCT07007325
Evaluation of the Value of [68Ga]Ga-PENTIXAFOR PET-CT in Patients With Metastatic Small Cell Lung Cancer (SCLC)
A Early Phase 1 study testing [68Ga]Ga-PentixaFor in people with Small Cell Lung Carcinoma (SCLC), run by Institut Cancerologie de l'Ouest at 3 sites in France.
Trial summary
[68Ga]Ga-PentixaFor PET-CT will be performed in patients with Small cell lung cancer (SCLC) to confirm the targeting of CXCR4 by [68Ga]Ga-PentixaFor Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma (SCLC)
- What is being tested?
- [68Ga]Ga-PentixaFor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesFrance
- Study dates
- 30 Sep 2026to 30 Sep 2030
- Phase
- Early Phase 1
- 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
Who may be able to join
- Written informed consent signed before performing any trial specific procedure.
- Male or female, age ≥ 18 years at time of study entry.
- Patient with histologically proven small cell lung carcinoma, inoperable, non-pre-treated.
- Metastatic disease documented by conventional imaging and/or [18F]FDG PET-CT with at least one metastatic measurable lesion (RECIST 1.1). Patients eligible for 1st line metastatic treatment.
- Availability of tissue material (primary lesion and/or metastatic site) to allow additional immunohistochemical studies.
- PS < 2.
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- Consent to use a contraception method for at least 3 months after each administration of [68Ga]Ga-PentixaFor.
- Adequate Organ function confirmed by laboratory test results allowing for safe the [68Ga]Ga-PentixaFor administration.
- Life expectancy greater than 3 months.
- Patient has valid health insurance.
- Patient willing and able to comply with the protocol throughout the duration of the study, including during treatment and scheduled visits and examinations, including follow-up.
Who cannot join
- History of cancer in the 3 years prior to entry into the trial other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of anti-cancer treatments such as chemotherapy, radiotherapy or immunotherapy as well as other clinical trials for SCLC before the first [68Ga]Ga-PentixaFor PET-CT imaging.
- Inability to lie still for at least 1 hour, or known claustrophobia.
- Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic) which may interfere with study objectives or patient safety or compliance, in the judgment of the investigator.
- Unstable diabetes with blood glucose > 2 g/L.
- Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PentixaFor and/or [18F]FDG product.
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- Body weight of less than 48 kg.
- Mental impairment that may compromise the ability to give informed consent and comply with study requirements.
- Pregnant, likely to be pregnant or breastfeeding woman.
- Patient deprived of liberty, under judicial safeguard, under curatorship or placed under the authority of a guardian.
- Disorder preventing understanding of trial information or informed consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Institut de cancérologie de l'ouest
Angers, 49055
Marie LACOMBE, MD, +33 241352700, Marie.Lacombe@ico.unicancer.fr
CHU d'Angers
Angers, 49100
Clément BOURON, MD, +33 241353406, Clement.Bouron@chu-angers.fr
Institut de cancérologie de l'ouest
Saint-Herblain, 44805
Marie LACOMBE, MD, +33 241352700, Marie.Lacombe@ico.unicancer.fr
About this study
Official title: Prospective Feasibility Pilot Study Evaluating the Value of [68Ga]Ga-PENTIXAFOR PET-CT in Patients With Metastatic Small Cell Lung Cancer (SCLC) at Diagnosis and Disease Progression
[68Ga]Ga-PentixaFor PET-CT will be performed in patients with Small cell lung cancer (SCLC) to confirm the targeting of CXCR4 by [68Ga]Ga-PentixaFor
Read the detailed description
Small cell lung cancer (SCLC) accounts for approximately 15% of lung cancers, but remains a cancer with a poor prognosis, often detected at a metastatic stage and associated with a high rate of early recurrence.
Therapeutic options for unresectable SCLC are limited and essentially rely on first-line radiochemotherapy for limited disease or chemo-immunotherapy, possibly supplemented by radiotherapy, for extensive disease.
CXCR4 is a chemokine receptor that is highly expressed in this cancer. By targeting CXCR4 with [177Lu]Lu-PentixaTher or [90Y]Y-PentixaTher, patients with SCLC could benefit from a new type of treatment in this indication: Peptide Receptor Radionuclide Therapy (PRRT).
However, there is a need for a preliminary diagnostic study due to a lack of published data.
[68Ga]Ga-PentixaFor is an experimental compound that binds with high affinity to CXCR4 and appears to be a promising candidate for PET-CT imaging of SCLC. This initial step is crucial to confirm CXCR4 targeting by [68Ga]Ga-PentixaFor before considering PRRT with therapeutic radionuclides such as Lu-177 or Y-90 in future trials.
- Conditions
- Small Cell Lung Carcinoma (SCLC)
- Being tested
- [68Ga]Ga-PentixaFor
- Keywords
- Small Cell Lung Carcinoma (SCLC), [68Ga]Ga-PentixaFor, immunohistochemistry (IHC), CXCR4 expression, [18F]FDG, Safety
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-PentixaForDrug
Also called [68Ga]Ga-PentixaFor PET-CT
[68Ga]Ga-PentixaFor PET-CT
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-PentixaFor | Experimental | The patient receives a single dose I.V. injection of [68Ga]Ga-PentixaFor 150 (± 50) MBq, corresponding to a peptide mass dose of ≤ 50 μg per administration. Receives: Drug: [68Ga]Ga-PentixaFor |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the concordance of tumoral lesions detected between [68Ga]Ga-PentixaFor PET-CT and [18F]FDG PET-CT, considered as the reference, performed at diagnosis
The concordance between the two techniques ([18F]FDG PET-CT and [68Ga]Ga-PentixaFor PET-CT) will be assessed by lesion at diagnosis.
Cohen's Kappa coefficient will be calculated and accompanied by the probability of finding the same lesion on [68Ga]Ga-PentixaFor PET-CT knowing that it was present on [18F]FDG PET-CT (which may be similar to a measurement of sensitivity).
Measured: 30 days
Secondary outcomes (10)
Evaluate the concordance of tumoral lesions detected between [68Ga]Ga-PentixaFor PET-CT and [18F]FDG PET-CT, considered as the reference, performed at disease progression.
The concordance between the two techniques ([18F]FDG PET-CT and [68Ga]Ga-PentixaFor PET-CT) will be assessed by lesion at disease progression.
Cohen's Kappa coefficient will be calculated and accompanied by the probability of finding the same lesion on [68Ga]Ga-PentixaFor PET-CT knowing that it was present on [18F]FDG PET-CT (which may be similar to a measurement of sensitivity).
Measured: 24 months
Evaluate the diagnostic performances of [68Ga]Ga-PentixaFor PET-CT compared to [18F]FDG PET-CT considered as the reference.
The diagnostic performances will be assessed using the Specificity, at diagnosis time on one hand, and at disease progression time on the other hand.
Measured: 24 months
Evaluate the correlation between semi-quantitative data of [68Ga]Ga-PentixaFor PET-CT with CXCR4 expression on biopsies, assessed by immunohistochemistry (IHC).
The correlation between the standardized uptake values (SUV) of [68Ga]Ga-PentixaFor -positive lesions and the biological expression of CXCR4 will be described by Spearman's ρ, at diagnosis and at disease progression time if data are available.
Measured: 24 months
Describe the lesions identified by [68Ga]Ga-PentixaFor PET-CT and by [18F]FDG PET-CT.
The qualitative analysis will focus on lesion description in each major organ (lung, lymph node, bone marrow, brain...). Quantitative analysis will focus on continuous parameters at the lesion level (SUV, MTV, TLG and tumour-to-background ratio, etc.). The detection rate of tumour lesions will be calculated. This analysis will be conducted for each radiotracer at diagnosis time on one hand, and at disease progression time on the other hand.
Measured: 24 months
Compare the number of lesions detected by [18F]FDG PET-CT and those detected by [68Ga]Ga-PentixaFor PET-CT.
A comparison of all lesions number detected between the two radiotracers will be conducted at diagnosis time on one hand, and at disease progression time on the other hand.
Measured: 24 months
Description of the evolution of [68Ga]Ga-PentixaFor PET-CT data obtained at diagnosis and at disease progression time at the patient level.
Description of [68Ga]Ga-PentixaFor PET-CT data between diagnosis and disease progression time at the patient level will focus on the evolution of SUV value for each patient.
Measured: 24 months
Assess safety profile of [68Ga]Ga-PentixaFor.
The occurrence and the frequency of adverse events of [68Ga]Ga-PentixaFor will be assessed up to 48 hours after [68Ga]Ga-PentixaFor administration. The safety is assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Measured: 24 months
Description of the evolution of [68Ga]Ga-PentixaFor PET-CT data obtained at diagnosis and at disease progression time at the patient level.
Description of [68Ga]Ga-PentixaFor PET-CT data between diagnosis and disease progression time at the patient level will focus on the evolution of Total Lesion Uptake (TLU) value for each patient. TLU will be calculated from the total tumour volume and the lesions SUVmean.
Measured: 24 months
Evaluate the diagnostic performances of [68Ga]Ga-PentixaFor PET-CT compared to [18F]FDG PET-CT considered as the reference.
The diagnostic performances will be assessed using the Positive Predictive Value (PPV), at diagnosis time on one hand, and at disease progression time on the other hand.
Measured: 24 months
Evaluate the diagnostic performances of [68Ga]Ga-PentixaFor PET-CT compared to [18F]FDG PET-CT considered as the reference.
The diagnostic performances will be assessed using the Negative Predictive Value (NPV), at diagnosis time on one hand, and at disease progression time on the other hand.
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 posted5 Jun 2025
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Carcinoma (SCLC)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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie LACOMBE, MD, Principal investigator, Institut de Cancérologie de l'Ouest (ICO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007325
- Sponsor's protocol ID
- ICO-2023-16
- Acronym
- PASSIFLORE
- Status last verified
- Jun 2026
- First submitted
- 20 Mar 2025
- Last updated
- 18 Jun 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Feasibility Pilot Study Evaluating the Value of [68Ga]Ga-PENTIXAFOR PET-CT in Patients With Metastatic Small Cell Lung Cancer (SCLC) at Diagnosis and Disease Progression
- ClinicalTrials.gov ID
- NCT07007325
- Acronym / sponsor ID
- PASSIFLORE / ICO-2023-16
- Conditions
- Small Cell Lung Carcinoma (SCLC)
- Keywords
- Small Cell Lung Carcinoma (SCLC), [68Ga]Ga-PentixaFor, immunohistochemistry (IHC), CXCR4 expression, [18F]FDG, Safety
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 5 Jun 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.
[68Ga]Ga-PentixaFor PET-CT will be performed in patients with Small cell lung cancer (SCLC) to confirm the targeting of CXCR4 by [68Ga]Ga-PentixaFor
Detailed description
Small cell lung cancer (SCLC) accounts for approximately 15% of lung cancers, but remains a cancer with a poor prognosis, often detected at a metastatic stage and associated with a high rate of early recurrence.
Therapeutic options for unresectable SCLC are limited and essentially rely on first-line radiochemotherapy for limited disease or chemo-immunotherapy, possibly supplemented by radiotherapy, for extensive disease.
CXCR4 is a chemokine receptor that is highly expressed in this cancer. By targeting CXCR4 with [177Lu]Lu-PentixaTher or [90Y]Y-PentixaTher, patients with SCLC could benefit from a new type of treatment in this indication: Peptide Receptor Radionuclide Therapy (PRRT).
However, there is a need for a preliminary diagnostic study due to a lack of published data.
[68Ga]Ga-PentixaFor is an experimental compound that binds with high affinity to CXCR4 and appears to be a promising candidate for PET-CT imaging of SCLC. This initial step is crucial to confirm CXCR4 targeting by [68Ga]Ga-PentixaFor before considering PRRT with therapeutic radionuclides such as Lu-177 or Y-90 in future trials.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-PentixaFor | Experimental | Drug: [68Ga]Ga-PentixaForThe patient receives a single dose I.V. injection of [68Ga]Ga-PentixaFor 150 (± 50) MBq, corresponding to a peptide mass dose of ≤ 50 μg per administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent signed before performing any trial specific procedure.
- Male or female, age ≥ 18 years at time of study entry.
- Patient with histologically proven small cell lung carcinoma, inoperable, non-pre-treated.
- Metastatic disease documented by conventional imaging and/or [18F]FDG PET-CT with at least one metastatic measurable lesion (RECIST 1.1). Patients eligible for 1st line metastatic treatment.
- Availability of tissue material (primary lesion and/or metastatic site) to allow additional immunohistochemical studies.
Key exclusion criteria (11 listed)
- History of cancer in the 3 years prior to entry into the trial other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of anti-cancer treatments such as chemotherapy, radiotherapy or immunotherapy as well as other clinical trials for SCLC before the first [68Ga]Ga-PentixaFor PET-CT imaging.
- Inability to lie still for at least 1 hour, or known claustrophobia.
- Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic) which may interfere with study objectives or patient safety or compliance, in the judgment of the investigator.
- Unstable diabetes with blood glucose > 2 g/L.
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 |
|---|---|---|
| [68Ga]Ga-PentixaForAlso: [68Ga]Ga-PentixaFor PET-CT[68Ga]Ga-PentixaFor PET-CT | Drug | [68Ga]Ga-PentixaFor |
Primary outcome
To evaluate the concordance of tumoral lesions detected between [68Ga]Ga-PentixaFor PET-CT and [18F]FDG PET-CT, considered as the reference, performed at diagnosis
Time frame: 30 days
The concordance between the two techniques ([18F]FDG PET-CT and [68Ga]Ga-PentixaFor PET-CT) will be assessed by lesion at diagnosis. Cohen's Kappa coefficient will be calculated and accompanied by the probability of finding the same lesion on [68Ga]Ga-PentixaFor PET-CT knowing that it was present on [18F]FDG PET-CT (which may be similar to a measurement of sensitivity).
10 secondary outcomes
Evaluate the concordance of tumoral lesions detected between [68Ga]Ga-PentixaFor PET-CT and [18F]FDG PET-CT, considered as the reference, performed at disease progression.
Time frame: 24 months
Evaluate the diagnostic performances of [68Ga]Ga-PentixaFor PET-CT compared to [18F]FDG PET-CT considered as the reference.
Time frame: 24 months
Evaluate the correlation between semi-quantitative data of [68Ga]Ga-PentixaFor PET-CT with CXCR4 expression on biopsies, assessed by immunohistochemistry (IHC).
Time frame: 24 months
Describe the lesions identified by [68Ga]Ga-PentixaFor PET-CT and by [18F]FDG PET-CT.
Time frame: 24 months
Compare the number of lesions detected by [18F]FDG PET-CT and those detected by [68Ga]Ga-PentixaFor PET-CT.
Time frame: 24 months
Description of the evolution of [68Ga]Ga-PentixaFor PET-CT data obtained at diagnosis and at disease progression time at the patient level.
Time frame: 24 months
Assess safety profile of [68Ga]Ga-PentixaFor.
Time frame: 24 months
Description of the evolution of [68Ga]Ga-PentixaFor PET-CT data obtained at diagnosis and at disease progression time at the patient level.
Time frame: 24 months
Evaluate the diagnostic performances of [68Ga]Ga-PentixaFor PET-CT compared to [18F]FDG PET-CT considered as the reference.
Time frame: 24 months
Evaluate the diagnostic performances of [68Ga]Ga-PentixaFor PET-CT compared to [18F]FDG PET-CT considered as the reference.
Time frame: 24 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 18 Jun 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.
Marie LACOMBE, MD principal investigator
Institut de Cancérologie de l'Ouest (ICO)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [68Ga]Ga-PentixaFor in people with Small Cell Lung Carcinoma (SCLC), run by Institut Cancerologie de l'Ouest at 3 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 11 inclusion and 11 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: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Marie LACOMBE, MD (+33 241352700, Marie.Lacombe@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the concordance of tumoral lesions detected between [68Ga]Ga-PentixaFor PET-CT and [18F]FDG PET-CT, considered as the reference, performed at diagnosis (time frame: 30 days). 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 18 Jun 2026.