Carcinoma, Non-Small-Cell LungIMKRUN 2NCT02847377
A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
A study testing Injection of [18F]-ODS2004436 radiotracer in people with Carcinoma, Non-Small-Cell Lung, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
The development of biomarkers will lead the dynamic of personalized medicine and fill the unsatisfied needs in oncology for prediction of therapeutic response. Molecular imaging enables non invasive quantification of biomarkers. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Injection of [18F]-ODS2004436 radiotracer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 27 Sep 2016to 19 Mar 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than 18 years,
- Willing and able to sign written informed consent,
- Histologically confirmed diagnosis of adenocarcinoma NSCLC:
- positive mutated KRas homogeneous population for EGFR Wild type (WT) patients (exclusive with EGFR mutation)
- EGFR activating mutation (All mutations: 719, 790, 861, 858 or del exon 19 and exon 20),
- Patient with EGFR mutation will be sensitive to TKI
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- Treatment naïve patients,
- Performance status ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) criteria,
- No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital, phenytoin, ketoconazole,
- Adequate hematologic (ANC count ≥ 1,500/uL, platelet count ≥ 100,000/mm3), hepatic (bilirubin level ≤ 1.5 mg/dL, Transaminase (AST/ALT) ≤ 80 IU/L), and renal (creatinine concentration ≤ 1.5 mg/dL) function,
- Patients with brain metastasis are allowed unless there were clinically significant neurological symptoms or signs.
Who cannot join
- Known severe hypersensitivity to Gefitinib or Afatinib or any of the tablet excipients,
- Inability to swallow tablets,
- Other coexisting malignant disease,
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's wort; severe or uncontrolled systemic disease; clinically active interstitial lung disease (except uncomplicated lymphangitic carcinomatosis),
- Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control,
- Subjects under guardianship, curators or judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Phase 0/1 of Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
The development of biomarkers will lead the dynamic of personalized medicine and fill the unsatisfied needs in oncology for prediction of therapeutic response.
Molecular imaging enables non invasive quantification of biomarkers. The development of molecular imaging biomarkers is closely related to the development of therapeutic molecules. Among the potential targets, kinases offer a lot of advantages: (i) they play a central role in cellular regulation, (ii) numerous kinase-specific small molecule libraries exist in biotech and pharma industry, (iii) several kinase-targeted therapies are used in clinic (imatinib, sorafenib, sunitinib…) with application across a variety of therapeutic indications. Among the imaging technologies, the Positron Emission Tomography (PET) is the most sensitive and dedicated to evaluate small molecules. However few radiotracers are available and their specificity limits their clinical use. The IMAkinib® approach is an innovative method proposed to develop new PET radiotracers adapted to current medical and economical challenges.
The epidermal growth factor receptor (EGFR) is an established target for the treatment of advanced non-small cell lung cancer (NSCLC). The EGFR tyrosine kinase inhibitors (TKIs) Gefitinib (Iressa®), erlotinib (Tarceva®) and afatinib (Giotrif®) have already been approved for treatment of NSCLC harboring EGFR activating mutations (L858R or del exon 19). Unfortunately the majority of patients will develop a resistance to the TKI in the long term (6-12 months). If the mechanism of resistance is not yet fully characterized, most patients (50%) will acquire an additional T790M mutation of EGFR. TKI PET-imaging can provide a tool to determine and predict responsiveness to EGFR TKI in vivo. That is why, the investigators have selected and radiolabeled (18-Fluor) a compound targeting specifically EGFR mutated ([18F]-ODS2004436) which was further evaluated in a preclinical imaging study to determine the feasibility of TKI-PET. The investigators proved in vivo that [18F]-ODS2004436 a compound is a good candidate to evaluate the EGFR activity in human lung tumours using PET imaging.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Injection of [18F]-ODS2004436 radiotracer
- 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.
Injection of [18F]-ODS2004436 radiotracerOther
| Study group | Role | What they receive |
|---|---|---|
| [18F]-ODS2004436 | Experimental | Two TEP will be performed with the radiotracer [18F]-ODS2004436 Receives: Other: Injection of [18F]-ODS2004436 radiotracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of sensibility of [18F] ODS2004436
Sensibility will be evaluated by positron emission tomography (PET) performed on EGFR mutant patient
Measured: 1 day
Evaluation of specificity of [18F] ODS2004436
Specificity will be evaluated by positron emission tomography (PET) performed on EGFR wild type patient
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start27 Sep 2016
- Primary completion27 Sep 2016
- Study completion19 Mar 2019
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 LungStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre FUMOLEAU, Pr, Study director, Centre Georges Francois Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847377
- Sponsor's protocol ID
- IMK RUN 2
- Acronym
- IMKRUN 2
- Status last verified
- Nov 2019
- First submitted
- 12 Jul 2016
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Phase 0/1 of Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
- ClinicalTrials.gov ID
- NCT02847377
- Acronym / sponsor ID
- IMKRUN 2 / IMK RUN 2
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 27 Sep 2016 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 28 Jul 2016 (estimated)
- 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 development of biomarkers will lead the dynamic of personalized medicine and fill the unsatisfied needs in oncology for prediction of therapeutic response.
Molecular imaging enables non invasive quantification of biomarkers. The development of molecular imaging biomarkers is closely related to the development of therapeutic molecules. Among the potential targets, kinases offer a lot of advantages: (i) they play a central role in cellular regulation, (ii) numerous kinase-specific small molecule libraries exist in biotech and pharma industry, (iii) several kinase-targeted therapies are used in clinic (imatinib, sorafenib, sunitinib…) with application across a variety of therapeutic indications. Among the imaging technologies, the Positron Emission Tomography (PET) is the most sensitive and dedicated to evaluate small molecules. However few radiotracers are available and their specificity limits their clinical use. The IMAkinib® approach is an innovative method proposed to develop new PET radiotracers adapted to current medical and economical challenges.
The epidermal growth factor receptor (EGFR) is an established target for the treatment of advanced non-small cell lung cancer (NSCLC). The EGFR tyrosine kinase inhibitors (TKIs) Gefitinib (Iressa®), erlotinib (Tarceva®) and afatinib (Giotrif®) have already been approved for treatment of NSCLC harboring EGFR activating mutations (L858R or del exon 19). Unfortunately the majority of patients will develop a resistance to the TKI in the long term (6-12 months). If the mechanism of resistance is not yet fully characterized, most patients (50%) will acquire an additional T790M mutation of EGFR. TKI PET-imaging can provide a tool to determine and predict responsiveness to EGFR TKI in vivo. That is why, the investigators have selected and radiolabeled (18-Fluor) a compound targeting specifically EGFR mutated ([18F]-ODS2004436) which was further evaluated in a preclinical imaging study to determine the feasibility of TKI-PET. The investigators proved in vivo that [18F]-ODS2004436 a compound is a good candidate to evaluate the EGFR activity in human lung tumours using PET imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]-ODS2004436 | Experimental | Other: Injection of [18F]-ODS2004436 radiotracerTwo TEP will be performed with the radiotracer [18F]-ODS2004436 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- more than 18 years,
- Willing and able to sign written informed consent,
- Histologically confirmed diagnosis of adenocarcinoma NSCLC:
- Patient with EGFR mutation will be sensitive to TKI
- Treatment naïve patients,
Key exclusion criteria (6 listed)
- Known severe hypersensitivity to Gefitinib or Afatinib or any of the tablet excipients,
- Inability to swallow tablets,
- Other coexisting malignant disease,
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's wort; severe or uncontrolled systemic disease; clinically active interstitial lung disease (except uncomplicated lymphangitic carcinomatosis),
- Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control,
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 |
|---|---|---|
| Injection of [18F]-ODS2004436 radiotracer | Other | [18F]-ODS2004436 |
Primary outcome
Evaluation of sensibility of [18F] ODS2004436
Time frame: 1 day
Sensibility will be evaluated by positron emission tomography (PET) performed on EGFR mutant patient
Evaluation of specificity of [18F] ODS2004436
Time frame: 1 day
Specificity will be evaluated by positron emission tomography (PET) performed on EGFR wild type patient
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 27 Jan 2020.
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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.
Pierre FUMOLEAU, Pr study director
Centre Georges Francois Leclerc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of [18F]-ODS2004436 radiotracer in people with Carcinoma, Non-Small-Cell Lung, run by Centre Georges Francois Leclerc 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 11 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 27 Jan 2020. 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?
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?
Evaluation of sensibility of [18F] ODS2004436 (time frame: 1 day). The study lists 2 primary outcomes in all. 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 27 Jan 2020.