Immunological Markers Predictive of Response and Toxicity to Checkpoint Inhibitors in Non-small Cell Lung Cancer (IMMUNO-PREDICT)

Immunological Markers Predictive of Response and Toxicity to Checkpoint in Metastatic Non-Small-cell Lung Cancers

A prospective, observational, single-center study to determine the proportion of patients who have or will develop changes in biological markers of immunity during immunotherapy treatment.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer

Detailed Description

The study will run for 12 months with a 6-month follow-up at the inclusion of the last patient.

Patients will be included from the initiation of immunotherapy treatment regardless of the line.The routine immunological workup will be performed before the first immunotherapy infusion in order to analyze a certain number of immunological markers (autoantibodies, RF, LDH, complement (C3 C4), anti-tissue antibodies, lymphocyte immunophenotyping). This assessment will then be performed at progression, at the appearance of side effects requiring the immunotherapy to be stopped, or at 6 months of follow-up in case of continuation of the immunotherapy.

The investigators will evaluate the response to the treatment, the progression via re-evaluation assessments performed in standard practice (every 3 to 4 courses depending on the type of immunotherapy) as well as the appearance of side effects throughout the follow-up will be evaluate.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Gilles QUERE; Phone Number: 0298223740; Email: gilles.quere@chu-brest.fr
• Study Contact Backup: Name: Renaud DESCOURT; Email: renaud.descourt@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHRU de Brest
    • Contact: Gilles QUERE; Email: gilles.quere@chu-brest.fr

Participation Criteria

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

Patients with metastatic non-small cell lung cancer receiving immunotherapy (NIVOLUMAB, PEMBROLIZUMAB or ATEZOLIZUMAB) regardless of the line of treatment in daily practice

Description

Inclusion Criteria:

• Major patient
• Metastatic non-small cell lung cancer
• Initiation of anti PDL1 therapy (NIVOLUMAB, PEMBROLIZUMAB or ATEZOLIZUAMB) in daily practice
• No objection made

Exclusion Criteria:

• Autoimmune disease diagnosed prior to initiation of immune checkpoint inhibitor therapy.
• Previous immune-modulating therapy (including corticosteroid therapy greater than 10 mg/day)
• Patient with prior checkpoint inhibitor therapy
• Patient with a contraindication to immunotherapy
• Patient under legal protection
• Refusal to participate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of biological markers of immunity under immunotherapy at 6 months	Determine the proportion of patients who have or will develop a change in biological markers of immunity under immunotherapy at 6 months or, failing that, at the end of the immunotherapy (FAN and/or RF and/or anti-tissue and/or decrease in acquired complement verified on the difference between 6 months and inclusion, lymphocyte immunophenotyping)	Day 0 and month 6 (M6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on Overall Survival (OS) and Progression Free Survival (PFS)	Determine if the presence of biological markers of autoimmunity at initiation or during anti-PD1/PDL1 immunotherapy influences overall survival or progression-free survival.	Day 0 and Six month after (M6)
Impact on autoimmune toxicity	Determine if the presence of biological markers of autoimmunity (at inclusion, at 6 months or at progression) is associated with autoimmune toxicity (any clinical or biological autoimmune event regardless of its grade). Determine if the presence of biological markers of autoimmunity (at inclusion, at 6 months or at progression) is associated with autoimmune toxicity (any clinical or biological autoimmune event regardless of its grade).	Day 0 and month 6 (M6)
Impact of complement	Determine if the decrease in complement at 6 months is associated with autoimmune toxicity.	Day 0 and month 6 (M6)
Impact of autoimmune toxicity on OS	Determine if the occurrence of autoimmune toxicity during anti-PD1/PDL1 immunotherapy for non-small cell lung cancer influences the patient's overall survival.	Day 0 and month 6 (M6)
Impact of autoimmune toxicity on PFS	Determine if the occurrence of autoimmune toxicity during anti-PD1/PDL1 immunotherapy for non-small cell lung cancer influences the patient's progression-free survival.	Day 0 and month 6 (M6)
Impact of clinical factors	Determine if clinical factors (undernutrition, tumor mass, general condition) at initiation or during anti-PD1/PDL1 immunotherapy influence patient's overall survival and progression-free survival	Day 0 and month 6 (M6)
Study the clinical factors influencing the immune profile	Study the clinical factors influencing the immune profile	Day 0 and month 6 (M6)
Impact of CRP and lymphopenia	Determine if CRP and the presence of initial lymphopenia influence the presence or induction of an immunological abnormality	Day 0 and month 6 (M6)

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Anticipated): October 8, 2021
• Study Completion (Anticipated): October 8, 2022

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: Immuno-PREDICT ( 29BRC21.0021)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning 18 months and ending five years following the publication
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No