Energy for Lymphocytes (ELY)

May 10, 2021 updated by: Camille Levalois, Hôpital Cochin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with NSCLC initiating nivolumab or pembrolizumab in real-life conditions

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Resting Energy Expenditure measurement
Resting Energy Expenditure measurement using indirect calorimetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Cochin

Collaborators

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCochin

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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