Non-small Cell Lung CancerELYNCT04879316
Energy for Lymphocytes
An observational study of Non-small Cell Lung Cancer and Progression, Disease, run by Hôpital Cochin at 1 site in France.
Trial summary
CERTIM is a cohort created in July 2015 to set up a multidisciplinary follow-up of cancer patients treated with immune checkpoint inhibitors. From the CERTIM cohort, we conducted a longitudinal, prospective, observational study (ELY) in two tertiary university centers (Cochin hospital and European Georges Pompidou… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Progression, Disease
- What is being tested?
- Resting Energy Expenditure measurement
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2016to 30 Apr 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: Adult patients with NSCLC initiating nivolumab or pembrolizumab in real-life conditions
Who may be able to join
- 18 years or older
- Stage IV histologically proven Non Small Cell Lung Cancer (NSCLC)
- Monotherapy with nivolumab or pembrolizumab.
- Patients were required to have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Who cannot join
- Active malignancy other than NSCLC,
- ALK or EGFR mutated NSCLC
- Anticancer therapy or surgery within the past 2 weeks or inability to breathe under the calorimetry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Nutritional Biomarkers to Predict the Efficacy of Immunotherapy by Anti-PD/PDL1 Checkpoints Inhibitors in Metastatic Non-small Cell Lung Cancer Patients
CERTIM is a cohort created in July 2015 to set up a multidisciplinary follow-up of cancer patients treated with immune checkpoint inhibitors.
From the CERTIM cohort, we conducted a longitudinal, prospective, observational study (ELY) in two tertiary university centers (Cochin hospital and European Georges Pompidou Hospital), which included patients between August 2016 and October 2019 and ended follow-up in April 2020.
Patients were treated with nivolumab, at a dose of 3 mg/kg every 2 weeks, or pembrolizumab, at a dose of 2mg/kg every 3 weeks. The investigators report findings from an evaluation of rest energy expenditure (REE) assessed using indirect calorimetry in the outpatient setting before treatment with checkpoints inhibitors.
- Conditions
- Non-small Cell Lung Cancer, Progression, Disease
- Being tested
- Resting Energy Expenditure measurement
- Keywords
- cachexia, immunotherapy, carcinoma, Non-small cell lung cancer, Basal metabolism, Energy expenditure, inflammation, 6-month Progression free survival
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Disease Progression, Cachexia, Carcinoma, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting Energy Expenditure measurementOther
Resting Energy Expenditure measurement using indirect calorimetry
| Study group | Role | What they receive |
|---|---|---|
| adult patients with NSCLC initiating nivolumab or pembrolizumab | Patients underwent a multidisciplinary evaluation including consultation with an oncologist and a dietitian. Such an assessment includes subjective and objective parameters such as medical history, weight loss, current dietary intake (including energy and protein balance), physical examination and anthropometric measurements, functional and mental assessment, medications, Resting Energy Expenditure measurement using indirect calorimetry and laboratory values. Receives: Other: Resting Energy Expenditure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month Progression-free survival
Calculated as the percentage of participants alive and without disease progression, as assessed by the Investigator using RECIST v1.1
Measured: 6 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Aug 2016
- Primary completion1 Oct 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hôpital Cochin
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Principal investigator, Camille Levalois, Hôpital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879316
- Sponsor's protocol ID
- HCochin
- Acronym
- ELY
- Status last verified
- May 2021
- First submitted
- 12 Apr 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Montegut L, Joseph A, Chen H, Abdellatif M, Ruckenstuhl C, Motino O, Lambertucci F, Anagnostopoulos G, Lachkar S, Dichtinger S, Maiuri MC, Goldwasser F, Blanchet B, Fumeron F, Martins I, Madeo F, Kroemer G. High plasma concentrations of acyl-coenzyme A binding protein (ACBP) predispose to cardiovascular disease: Evidence for a phylogenetically conserved proaging function of ACBP. Aging Cell. 2023 Jan;22(1):e13751. doi: 10.1111/acel.13751. Epub 2022 Dec 12.
PubMed 36510662
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Nutritional Biomarkers to Predict the Efficacy of Immunotherapy by Anti-PD/PDL1 Checkpoints Inhibitors in Metastatic Non-small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT04879316
- Acronym / sponsor ID
- ELY / HCochin
- Conditions
- Non-small Cell Lung Cancer, Progression, Disease
- Keywords
- cachexia, immunotherapy, carcinoma, Non-small cell lung cancer, Basal metabolism, Energy expenditure, inflammation, 6-month Progression free survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Hôpital CochinUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 10 May 2021 (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.
CERTIM is a cohort created in July 2015 to set up a multidisciplinary follow-up of cancer patients treated with immune checkpoint inhibitors.
From the CERTIM cohort, we conducted a longitudinal, prospective, observational study (ELY) in two tertiary university centers (Cochin hospital and European Georges Pompidou Hospital), which included patients between August 2016 and October 2019 and ended follow-up in April 2020.
Patients were treated with nivolumab, at a dose of 3 mg/kg every 2 weeks, or pembrolizumab, at a dose of 2mg/kg every 3 weeks. The investigators report findings from an evaluation of rest energy expenditure (REE) assessed using indirect calorimetry in the outpatient setting before treatment with checkpoints inhibitors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients with NSCLC initiating nivolumab or pembrolizumab | – | Other: Resting Energy Expenditure measurementPatients underwent a multidisciplinary evaluation including consultation with an oncologist and a dietitian. Such an assessment includes subjective and objective parameters such as medical history, weight loss, current dietary intake (including energy and protein balance), physical examination and anthropometric measurements, functional and mental assessment, medications, Resting Energy Expenditure measurement using indirect calorimetry and laboratory values. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with NSCLC initiating nivolumab or pembrolizumab in real-life conditions
Key inclusion criteria (4 listed)
- 18 years or older
- Stage IV histologically proven Non Small Cell Lung Cancer (NSCLC)
- Monotherapy with nivolumab or pembrolizumab.
- Patients were required to have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Key exclusion criteria (3 listed)
- Active malignancy other than NSCLC,
- ALK or EGFR mutated NSCLC
- Anticancer therapy or surgery within the past 2 weeks or inability to breathe under the calorimetry.
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 |
|---|---|---|
| Resting Energy Expenditure measurementResting Energy Expenditure measurement using indirect calorimetry | Other | adult patients with NSCLC initiating nivolumab or pembrolizumab |
Primary outcome
6-month Progression-free survival
Time frame: 6 months after start of treatment
Calculated as the percentage of participants alive and without disease progression, as assessed by the Investigator using RECIST v1.1
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 12 May 2021.
- Derived from this study: PubMed 36510662Montegut L, Joseph A, Chen H, Abdellatif M, Ruckenstuhl C, Motino O, Lambertucci F, Anagnostopoulos G, Lachkar S, Dichtinger S, Maiuri MC, Goldwasser F, Blanchet B, Fumeron F, Martins I, Madeo F, Kroemer G. High plasma concentrations of acyl-coenzyme A binding protein (ACBP) predispose to cardiovascular disease: Evidence for a phylogenetically conserved proaging function of ACBP. Aging Cell. 2023 Jan;22(1):e13751. doi: 10.1111/acel.13751. Epub 2022 Dec 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and Progression, Disease, run by Hôpital Cochin 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 4 inclusion and 3 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 12 May 2021. 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?
6-month Progression-free survival (time frame: 6 months after start of treatment). 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 NCT04879316, which also lists 1 linked publication.
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 12 May 2021.