Energy for Lymphocytes

Analysis of Nutritional Biomarkers to Predict the Efficacy of Immunotherapy by Anti-PD/PDL1 Checkpoints Inhibitors in Metastatic Non-small Cell Lung Cancer Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04879316

Acronym

ELY

Enrollment

144

Registered

2021-05-10

Start date

2016-08-01

Completion date

2020-04-30

Last updated

2021-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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 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.

Interventions

OTHERResting Energy Expenditure measurement

Resting Energy Expenditure measurement using indirect calorimetry

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
6-month Progression-free survival	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026