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

• Conditions: Lung Cancer

• Registration Number: NCT04918836
• Lead Sponsor: University Hospital, Brest

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.

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 Timeline

• Study Start: 2021-04-08
• Study First Submitted: 2021-05-27
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-02
• Last Update Submitted: 2021-06-02
• Study First Posted: 2021-06-09
• Last Update Posted: 2021-06-09
• Primary Completion: 2021-10-08
• Study Completion: 2022-10-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of biological markers of immunity under immunotherapy at 6 months	Day 0 and month 6 (M6)	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France