Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Progression, Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Resting Energy Expenditure measurement | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- adult patients with NSCLC initiating nivolumab or pembrolizumab
- description
- 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.
- interventionNames
- Other: Resting Energy Expenditure measurement
Primary outcomes (1)
- measure
- 6-month Progression-free survival
- timeFrame
- 6 months after start of treatment
- description
- Calculated as the percentage of participants alive and without disease progression, as assessed by the Investigator using RECIST v1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMontegut 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. PMID 36510662