Evaluation of the Value of [68Ga]Ga-PENTIXAFOR PET-CT in Patients With Metastatic Small Cell Lung Cancer (SCLC)

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

Overview

\[68Ga\]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.

Interventions

• Drug [68Ga]Ga-PentixaFor
  \[68Ga\]Ga-PentixaFor PET-CT

Primary outcome measures

• 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]

Secondary outcome measures (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. [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]

Eligibility criteria

Inclusion criteria

• 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.
• 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.

Exclusion criteria

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 3 centers

• Institut de cancérologie de l'ouest — Angers
• CHU d'Angers — Angers
• Institut de cancérologie de l'ouest — Saint-Herblain

Identifiers

NCT: NCT07007325 · ICO-2023-16

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗