Lung Cancer
Conditions
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.
Interventions
None listed
Sponsors
University Hospital, Brest
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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 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 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. |
Countries
France
Contacts
Primary ContactGilles QUERE
Backup ContactRenaud Descourt
Outcome results
None listed