Energy for Lymphocytes

Non-small Cell Lung Cancer Clinical Trial

— ELY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04879316
• Other study ID #: HCochin
• Status: Completed
• Start date: August 1, 2016
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2021
• Source: Hôpital Cochin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: April 30, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Disease Progression
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Progression, Disease

Intervention

Other:
• Resting Energy Expenditure measurement
Resting Energy Expenditure measurement using indirect calorimetry

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Hôpital Cochin	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months after start of treatment