Clinical trial NCT04918836: Immunological Markers Predictive of Response and Toxicity to Checkpoint Inhibitors in Non-small Cell Lung Cancer
Official title: Immunological Markers Predictive of Response and Toxicity to Checkpoint in Metastatic Non-Small-cell Lung Cancers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of biological markers of immunity under immunotherapy at 6 months
timeFrame: Day 0 and month 6 (M6)
Secondary outcomes:
measure: Impact on Overall Survival (OS) and Progression Free Survival (PFS)
timeFrame: Day 0 and Six month after (M6)
measure: Impact on autoimmune toxicity
timeFrame: Day 0 and month 6 (M6)
measure: Impact of complement
timeFrame: Day 0 and month 6 (M6)
measure: Impact of autoimmune toxicity on OS
timeFrame: Day 0 and month 6 (M6)
measure: Impact of autoimmune toxicity on PFS
timeFrame: Day 0 and month 6 (M6)
measure: Impact of clinical factors
timeFrame: Day 0 and month 6 (M6)
measure: Study the clinical factors influencing the immune profile
timeFrame: Day 0 and month 6 (M6)
measure: Impact of CRP and lymphopenia
timeFrame: Day 0 and month 6 (M6)
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References: