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

NCT04918836 | Unknown

• 1 other identifier: Immuno-PREDICT ( 29BRC21.0021)
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Impact on Overall Survival (OS) and Progression Free Survival (PFS)

  Day 0 and Six month after (M6)

• Impact on autoimmune toxicity

  Day 0 and month 6 (M6)

• Impact of complement

  Day 0 and month 6 (M6)

• Impact of autoimmune toxicity on OS

  Day 0 and month 6 (M6)

• Impact of autoimmune toxicity on PFS

  Day 0 and month 6 (M6)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Gilles QUERE

CONTACT

0298223740; gilles.quere@chu-brest.fr

Renaud Descourt

CONTACT

renaud.descourt@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 9, 2021
• Study Start: April 8, 2021
• Primary Completion: October 8, 2021
• Study Completion: October 8, 2022
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 18 months and ending five years following the publication
• 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.

Locations

FR (1)