An observational study in Lung Cancer, sponsored by University Hospital, Brest. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-09.
Sponsored by University Hospital, Brest · Observational
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 150 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with metastatic non-small cell lung cancer receiving immunotherapy (NIVOLUMAB, PEMBROLIZUMAB or ATEZOLIZUMAB) regardless of the line of treatment in daily practice
Exclusion Criteria:
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)
Time frame: Day 0 and month 6 (M6)
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.
Time frame: Day 0 and Six month after (M6)
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).
Time frame: Day 0 and month 6 (M6)
Impact of complement
Determine if the decrease in complement at 6 months is associated with autoimmune toxicity.
Time frame: Day 0 and month 6 (M6)
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.
Time frame: Day 0 and month 6 (M6)
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.
Time frame: Day 0 and month 6 (M6)
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
Time frame: Day 0 and month 6 (M6)
Study the clinical factors influencing the immune profile
Study the clinical factors influencing the immune profile
Time frame: Day 0 and month 6 (M6)
Impact of CRP and lymphopenia
Determine if CRP and the presence of initial lymphopenia influence the presence or induction of an immunological abnormality
Time frame: Day 0 and month 6 (M6)
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Brest