Clinical trial NCT07007325: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Small Cell Lung Carcinoma (SCLC)
Keywords: Small Cell Lung Carcinoma (SCLC)
[68Ga]Ga-PentixaFor
immunohistochemistry (IHC)
CXCR4 expression
[18F]FDG
Safety
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent signed before performing any trial specific procedure.
2. Male or female, age ≥ 18 years at time of study entry.
3. Patient with histologically proven small cell lung carcinoma, inoperable, non-pre-treated.
4. 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.
5. Availability of tissue material (primary lesion and/or metastatic site) to allow additional immunohistochemical studies.
6. PS \< 2.
7. Consent to use a contraception method for at least 3 months after each administration of \[68Ga\]Ga-PentixaFor.
8. Adequate Organ function confirmed by laboratory test results allowing for safe the \[68Ga\]Ga-PentixaFor administration.
9. Life expectancy greater than 3 months.
10. Patient has valid health insurance.
11. 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.

Exclusion Criteria:

1. 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.
2. 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.
3. Inability to lie still for at least 1 hour, or known claustrophobia.
4. 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.
5. Unstable diabetes with blood glucose \> 2 g/L.
6. Known hypersensitivity to any active pharmaceutical agent or constituent of the \[68Ga\]Ga-PentixaFor and/or \[18F\]FDG product.
7. Body weight of less than 48 kg.
8. Mental impairment that may compromise the ability to give informed consent and comply with study requirements.
9. Pregnant, likely to be pregnant or breastfeeding woman.
10. Patient deprived of liberty, under judicial safeguard, under curatorship or placed under the authority of a guardian.
11. Disorder preventing understanding of trial information or informed consent.

Primary outcomes:
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
timeFrame: 30 days
Secondary outcomes:
measure: 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.
timeFrame: 24 months
measure: Evaluate the diagnostic performances of [68Ga]Ga-PentixaFor PET-CT compared to [18F]FDG PET-CT considered as the reference.
timeFrame: 24 months
measure: Evaluate the correlation between semi-quantitative data of [68Ga]Ga-PentixaFor PET-CT with CXCR4 expression on biopsies, assessed by immunohistochemistry (IHC).
timeFrame: 24 months
measure: Describe the lesions identified by [68Ga]Ga-PentixaFor PET-CT and by [18F]FDG PET-CT.
timeFrame: 24 months
measure: Compare the number of lesions detected by [18F]FDG PET-CT and those detected by [68Ga]Ga-PentixaFor PET-CT.
timeFrame: 24 months
measure: Description of the evolution of [68Ga]Ga-PentixaFor PET-CT data obtained at diagnosis and at disease progression time at the patient level.
timeFrame: 24 months
measure: Assess safety profile of [68Ga]Ga-PentixaFor.
timeFrame: 24 months
measure: Description of the evolution of [68Ga]Ga-PentixaFor PET-CT data obtained at diagnosis and at disease progression time at the patient level.
timeFrame: 24 months
measure: Evaluate the diagnostic performances of [68Ga]Ga-PentixaFor PET-CT compared to [18F]FDG PET-CT considered as the reference.
timeFrame: 24 months
measure: Evaluate the diagnostic performances of [68Ga]Ga-PentixaFor PET-CT compared to [18F]FDG PET-CT considered as the reference.
timeFrame: 24 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de cancérologie de l'ouest
city: Angers
country: France
facility: CHU d'Angers
city: Saint Herblain
country: France
facility: Institut de cancérologie de l'ouest
Study officials:
References: