Energy for Lymphocytes

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.

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Key information

Conditions

Non-small Cell Lung Cancer Body Weight Body Weight Changes Bronchial Neoplasms Cachexia Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Disease Attributes Disease Progression Inflammation Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Progression, Disease Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thinness Thoracic Neoplasms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cochin Hospital

Paris, 75014, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resting Energy Expenditure measurement

Other

Resting Energy Expenditure measurement using indirect calorimetry

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Hôpital Cochin

Other

Collaborators

Assistance Publique - Hôpitaux de Paris

Registry information

Official study 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

Acronym: ELY

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2020
First posted: May 10, 2021
Registry last updated: May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed