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

Regional University Hospital Center (CHRU)

Status: Unknown

Conditions: Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04918836

Immuno-PREDICT ( 29BRC21.0021)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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