Carcinoma, Non-Small-Cell LungNCT03563482
Correlation of Metabolic Imaging With Immune Markers in NSCLC Candidate to Immunotherapy.
A study testing PET scan in people with Carcinoma, Non-Small-Cell Lung and Positron-Emission Tomography, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The purpose of the present study is to prospectively investigate the correlation between the metabolic parameters on FDG-PET before and during immunotherapy treatment with the immune infiltrate and other tissue or circulating markers in a NSCLC patients candidate to immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Positron-Emission Tomography, Immunotherapy
- What is being tested?
- PET scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 31 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with pathological diagnosis of NSCLC eligible for immunotherapy;
- obtained informed consent.
Who cannot join
- age <18 years;
- pregnancy or breast-feeding.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Egesta Lopci, MD, PhD, +390282247542, egesta.lopci@gmail.com
Luca Toschi, MD, +390282245945, luca.toschi@humanitas.it
About this study
Official title: Correlazione Dell'Imaging Metabolico Con l'Espressione Dei Marcatori Immunitari Nei Pazienti Con NSCLC Candidati All'Immunoterapia.
The purpose of the present study is to prospectively investigate the correlation between the metabolic parameters on FDG-PET before and during immunotherapy treatment with the immune infiltrate and other tissue or circulating markers in a NSCLC patients candidate to immunotherapy.
Read the detailed description
This is an interventional prospective study without medication lasting 36 months, including an estimated period of 18 months for the enrolment and max 18 months of follow-up. All consecutive patients affected by NSCLC and referred for immunotherapy with the anti-PD-1 agent nivolumab, or other checkpoint inhibitors that may become available in the future, will be prospectively enrolled. The study cohort will consist of 40 patients.
All patients will undergo the following steps: 1) selection based on eligibility criteria and informed consent; 2) baseline examinations (ceCT and 18F-FDG PET/CT); 3) tumor biopsy and blood sampling; 4) Immunotherapy with check-point inhibitors; 5) response evaluation after 8 weeks of treatment (ceCT and 18F-FDG PET/CT) and second blood sampling; 6) follow up.
- Being tested
- PET scan
- 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.
PET scanDiagnostic test
Also called Biopsy
Tumor biopsy at baseline; PET scan performed after 8 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Biopsy and PET scan Receives: Diagnostic Test: PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate the tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.
Standardized uptake value
Measured: Baseline
Secondary outcomes (6)
Tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.
Metabolic tumor burden
Measured: Before treatment
Correlate immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.
Tumor infiltrate
Measured: Baseline
Evaluate the variation of metabolic parameters on FDG-PET in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.
Standardized uptake value
Measured: After 8 weeks of treatment
Quantify the variation of metabolic parameters on FDG-PET in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.
Metabolic tumor burden
Measured: After 8 weeks of treatment
Evaluate other tissue or circulating markers in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.
Tissue and blood samples
Measured: Baseline
Evaluate other tissue or circulating markers in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.
Tissue and blood samples
Measured: 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Egesta Lopci, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563482
- Sponsor's protocol ID
- 1670
- Status last verified
- Apr 2022
- First submitted
- 8 Jun 2018
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castello A, Grizzi F, Toschi L, Rossi S, Rahal D, Marchesi F, Russo C, Finocchiaro G, Lopci E. Tumor heterogeneity, hypoxia, and immune markers in surgically resected non-small-cell lung cancer. Nucl Med Commun. 2018 Jul;39(7):636-644. doi: 10.1097/MNM.0000000000000832.
PubMed 29608508Grizzi F, Castello A, Lopci E. Is it time to change our vision of tumor metabolism prior to immunotherapy? Eur J Nucl Med Mol Imaging. 2018 Jun;45(6):1072-1075. doi: 10.1007/s00259-018-3988-1. Epub 2018 Mar 12. No abstract available.
PubMed 29532102Rossi S, Toschi L, Castello A, Grizzi F, Mansi L, Lopci E. Clinical characteristics of patient selection and imaging predictors of outcome in solid tumors treated with checkpoint-inhibitors. Eur J Nucl Med Mol Imaging. 2017 Dec;44(13):2310-2325. doi: 10.1007/s00259-017-3802-5. Epub 2017 Aug 16.
PubMed 28815334Lopci E, Toschi L, Grizzi F, Rahal D, Olivari L, Castino GF, Marchetti S, Cortese N, Qehajaj D, Pistillo D, Alloisio M, Roncalli M, Allavena P, Santoro A, Marchesi F, Chiti A. Correlation of metabolic information on FDG-PET with tissue expression of immune markers in patients with non-small cell lung cancer (NSCLC) who are candidates for upfront surgery. Eur J Nucl Med Mol Imaging. 2016 Oct;43(11):1954-61. doi: 10.1007/s00259-016-3425-2. Epub 2016 Jun 1.
PubMed 27251642Castello A, Toschi L, Rossi S, Mazziotti E, Lopci E. The immune-metabolic-prognostic index and clinical outcomes in patients with non-small cell lung carcinoma under checkpoint inhibitors. J Cancer Res Clin Oncol. 2020 May;146(5):1235-1243. doi: 10.1007/s00432-020-03150-9. Epub 2020 Feb 11.
PubMed 32048008Rossi S, Castello A, Toschi L, Lopci E. Immunotherapy in non-small-cell lung cancer: potential predictors of response and new strategies to assess activity. Immunotherapy. 2018 Jul;10(9):797-805. doi: 10.2217/imt-2017-0187.
PubMed 30008262Castello A, Lopci E. Response assessment of bone metastatic disease: seeing the forest for the trees RECIST, PERCIST, iRECIST, and PCWG-2. Q J Nucl Med Mol Imaging. 2019 Jun;63(2):150-158. doi: 10.23736/S1824-4785.19.03193-5. Epub 2019 Jul 8.
PubMed 31286751Castello A, Rossi S, Mazziotti E, Toschi L, Lopci E. Hyperprogressive Disease in Patients with Non-Small Cell Lung Cancer Treated with Checkpoint Inhibitors: The Role of 18F-FDG PET/CT. J Nucl Med. 2020 Jun;61(6):821-826. doi: 10.2967/jnumed.119.237768. Epub 2019 Dec 20.
PubMed 31862803Monterisi S, Castello A, Toschi L, Federico D, Rossi S, Veronesi G, Lopci E. Preliminary data on circulating tumor cells in metastatic NSCLC patients candidate to immunotherapy. Am J Nucl Med Mol Imaging. 2019 Dec 15;9(6):282-295. eCollection 2019.
PubMed 31976158Castello A, Carbone FG, Rossi S, Monterisi S, Federico D, Toschi L, Lopci E. Circulating Tumor Cells and Metabolic Parameters in NSCLC Patients Treated with Checkpoint Inhibitors. Cancers (Basel). 2020 Feb 19;12(2):487. doi: 10.3390/cancers12020487.
PubMed 32092983Castello A, Lopci E. Update on tumor metabolism and patterns of response to immunotherapy. Q J Nucl Med Mol Imaging. 2020 Jun;64(2):175-185. doi: 10.23736/S1824-4785.20.03251-3. Epub 2020 Feb 27.
PubMed 32107904Castello A, Rossi S, Toschi L, Mansi L, Lopci E. Soluble PD-L1 in NSCLC Patients Treated with Checkpoint Inhibitors and Its Correlation with Metabolic Parameters. Cancers (Basel). 2020 May 27;12(6):1373. doi: 10.3390/cancers12061373.
PubMed 32471030Castello A, Rossi S, Toschi L, Lopci E. Comparison of Metabolic and Morphological Response Criteria for Early Prediction of Response and Survival in NSCLC Patients Treated With Anti-PD-1/PD-L1. Front Oncol. 2020 Jul 31;10:1090. doi: 10.3389/fonc.2020.01090. eCollection 2020.
PubMed 32850315Castello A, Lopci E. Reply: Diagnosis of Hyperprogressive Disease in Patients Treated with Checkpoint Inhibitors Using 18F-FDG PET/CT. J Nucl Med. 2020 Sep;61(9):1405. doi: 10.2967/jnumed.120.243444. Epub 2020 Mar 13. No abstract available.
PubMed 32169909Lopci E, Haanen JB. Cancer management in the era of immunotherapy: much more than meets the eye. Q J Nucl Med Mol Imaging. 2020 Jun;64(2):141-142. doi: 10.23736/S1824-4785.20.03252-5. Epub 2020 Feb 27. No abstract available.
PubMed 32107905
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlazione Dell'Imaging Metabolico Con l'Espressione Dei Marcatori Immunitari Nei Pazienti Con NSCLC Candidati All'Immunoterapia.
- ClinicalTrials.gov ID
- NCT03563482
- Acronym / sponsor ID
- 1670
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Jun 2018 (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 purpose of the present study is to prospectively investigate the correlation between the metabolic parameters on FDG-PET before and during immunotherapy treatment with the immune infiltrate and other tissue or circulating markers in a NSCLC patients candidate to immunotherapy.
Detailed description
This is an interventional prospective study without medication lasting 36 months, including an estimated period of 18 months for the enrolment and max 18 months of follow-up. All consecutive patients affected by NSCLC and referred for immunotherapy with the anti-PD-1 agent nivolumab, or other checkpoint inhibitors that may become available in the future, will be prospectively enrolled. The study cohort will consist of 40 patients.
All patients will undergo the following steps: 1) selection based on eligibility criteria and informed consent; 2) baseline examinations (ceCT and 18F-FDG PET/CT); 3) tumor biopsy and blood sampling; 4) Immunotherapy with check-point inhibitors; 5) response evaluation after 8 weeks of treatment (ceCT and 18F-FDG PET/CT) and second blood sampling; 6) follow up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Diagnostic Test: PET scanBiopsy and PET scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with pathological diagnosis of NSCLC eligible for immunotherapy;
- obtained informed consent.
Key exclusion criteria (2 listed)
- age <18 years;
- pregnancy or breast-feeding.
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 |
|---|---|---|
| PET scanAlso: BiopsyTumor biopsy at baseline; PET scan performed after 8 weeks of treatment | Diagnostic test | Experimental |
Primary outcome
Correlate the tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.
Time frame: Baseline
Standardized uptake value
6 secondary outcomes
Tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.
Time frame: Before treatment
Correlate immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.
Time frame: Baseline
Evaluate the variation of metabolic parameters on FDG-PET in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.
Time frame: After 8 weeks of treatment
Quantify the variation of metabolic parameters on FDG-PET in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.
Time frame: After 8 weeks of treatment
Evaluate other tissue or circulating markers in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.
Time frame: Baseline
Evaluate other tissue or circulating markers in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.
Time frame: 8 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 29608508Castello A, Grizzi F, Toschi L, Rossi S, Rahal D, Marchesi F, Russo C, Finocchiaro G, Lopci E. Tumor heterogeneity, hypoxia, and immune markers in surgically resected non-small-cell lung cancer. Nucl Med Commun. 2018 Jul;39(7):636-644. doi: 10.1097/MNM.0000000000000832.
- Background: PubMed 29532102Grizzi F, Castello A, Lopci E. Is it time to change our vision of tumor metabolism prior to immunotherapy? Eur J Nucl Med Mol Imaging. 2018 Jun;45(6):1072-1075. doi: 10.1007/s00259-018-3988-1. Epub 2018 Mar 12. No abstract available.
- Background: PubMed 28815334Rossi S, Toschi L, Castello A, Grizzi F, Mansi L, Lopci E. Clinical characteristics of patient selection and imaging predictors of outcome in solid tumors treated with checkpoint-inhibitors. Eur J Nucl Med Mol Imaging. 2017 Dec;44(13):2310-2325. doi: 10.1007/s00259-017-3802-5. Epub 2017 Aug 16.
- Background: PubMed 27251642Lopci E, Toschi L, Grizzi F, Rahal D, Olivari L, Castino GF, Marchetti S, Cortese N, Qehajaj D, Pistillo D, Alloisio M, Roncalli M, Allavena P, Santoro A, Marchesi F, Chiti A. Correlation of metabolic information on FDG-PET with tissue expression of immune markers in patients with non-small cell lung cancer (NSCLC) who are candidates for upfront surgery. Eur J Nucl Med Mol Imaging. 2016 Oct;43(11):1954-61. doi: 10.1007/s00259-016-3425-2. Epub 2016 Jun 1.
- Background: PubMed 32048008Castello A, Toschi L, Rossi S, Mazziotti E, Lopci E. The immune-metabolic-prognostic index and clinical outcomes in patients with non-small cell lung carcinoma under checkpoint inhibitors. J Cancer Res Clin Oncol. 2020 May;146(5):1235-1243. doi: 10.1007/s00432-020-03150-9. Epub 2020 Feb 11.
- Background: PubMed 30008262Rossi S, Castello A, Toschi L, Lopci E. Immunotherapy in non-small-cell lung cancer: potential predictors of response and new strategies to assess activity. Immunotherapy. 2018 Jul;10(9):797-805. doi: 10.2217/imt-2017-0187.
- Background: PubMed 31286751Castello A, Lopci E. Response assessment of bone metastatic disease: seeing the forest for the trees RECIST, PERCIST, iRECIST, and PCWG-2. Q J Nucl Med Mol Imaging. 2019 Jun;63(2):150-158. doi: 10.23736/S1824-4785.19.03193-5. Epub 2019 Jul 8.
- Background: PubMed 31862803Castello A, Rossi S, Mazziotti E, Toschi L, Lopci E. Hyperprogressive Disease in Patients with Non-Small Cell Lung Cancer Treated with Checkpoint Inhibitors: The Role of 18F-FDG PET/CT. J Nucl Med. 2020 Jun;61(6):821-826. doi: 10.2967/jnumed.119.237768. Epub 2019 Dec 20.
- Background: PubMed 31976158Monterisi S, Castello A, Toschi L, Federico D, Rossi S, Veronesi G, Lopci E. Preliminary data on circulating tumor cells in metastatic NSCLC patients candidate to immunotherapy. Am J Nucl Med Mol Imaging. 2019 Dec 15;9(6):282-295. eCollection 2019.
- Background: PubMed 32092983Castello A, Carbone FG, Rossi S, Monterisi S, Federico D, Toschi L, Lopci E. Circulating Tumor Cells and Metabolic Parameters in NSCLC Patients Treated with Checkpoint Inhibitors. Cancers (Basel). 2020 Feb 19;12(2):487. doi: 10.3390/cancers12020487.
- Background: PubMed 32107904Castello A, Lopci E. Update on tumor metabolism and patterns of response to immunotherapy. Q J Nucl Med Mol Imaging. 2020 Jun;64(2):175-185. doi: 10.23736/S1824-4785.20.03251-3. Epub 2020 Feb 27.
- Background: PubMed 32471030Castello A, Rossi S, Toschi L, Mansi L, Lopci E. Soluble PD-L1 in NSCLC Patients Treated with Checkpoint Inhibitors and Its Correlation with Metabolic Parameters. Cancers (Basel). 2020 May 27;12(6):1373. doi: 10.3390/cancers12061373.
- Individual participant dataSharing planned: No
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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.
Egesta Lopci principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET scan in people with Carcinoma, Non-Small-Cell Lung and Positron-Emission Tomography, run by Istituto Clinico Humanitas at 1 site in Italy.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Apr 2022. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michele Tedeschi, MD (+390282241, michele.tedeschi@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate the tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03563482, which also lists 17 linked publications.
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 28 Apr 2022.