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

Lung Cancer Clinical Trial

— IMMUNO-PREDICT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04918836
• Other study ID #: Immuno-PREDICT ( 29BRC21.0021)
• Status: Recruiting
• Start date: April 8, 2021
• Est. completion date: October 8, 2022

Study information

• Verified date: June 2021
• Source: University Hospital, Brest
• Contact: Gilles QUERE
• Phone: 0298223740
• Email: gilles.quere[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 8, 2022
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Impact of complement	Determine if the decrease in complement at 6 months is associated with autoimmune toxicity.	Day 0 and month 6 (M6)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Study the clinical factors influencing the immune profile	Study the clinical factors influencing the immune profile	Day 0 and month 6 (M6)
Secondary	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)