Study Investigating Anti-drug Antibodies in NSCLC Patients Exposed to Checkpoint Inhibitors (IMB)
ConditionNSCLC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Ricerca Traslazionale
About this trial
Non-small cell lung cancer (NSCLC) is one of the leading causes of death in Western countries. Today, a new frontier in the fight against cancer is immunotherapy, a treatment that aims to "awaken" the patient's immune system to help it recognize and attack cancer cells.
Among the various approaches, there is significant focus on therapies that activate T lymphocytes, a type of immune cell, encouraging them to react against the tumor. These treatments have led to important progress and represent a hope for the future.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed diagnosis of NSCLC
Possibility to obtain blood samples
Patient candidate, in any therapy line, for a therapy with any checkpoint inhibitor including single agent pembrolizumab, single agent atezolizumab, single agent nivolumab, single agent durvalumab or combination of nivolumab and ipilimumab
Performance status 0-2 (ECOG)
Disqualifiers
No possibility to obtain blood samples
Previous therapy with any checkpoint inhibitor
Patient candidate for a therapy with a checkpoint inhibitor in combination with chemotherapy or any other non-checkpoint inhibitors
Pregnancy or lactating
Trial population
The study population will include NSCLC patients candidate, in any therapy line, for a therapy with any checkpoint inhibitor including single agent pembrolizumab, single agent atezolizumab, single agent nivolumab, single agent durvalumab or combination of nivolumab and ipilimumab
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Detection of Anti-Checkpoint Inhibitor Antibodies in Plasma of Participants Receiving Treatment
Detection of anti-checkpoint inhibitors antibodies in plasma
Time frame
From the start of treatment until the first documented progression, completion of treatment cycles, or death from any cause, whichever occurs first, assessed from the start of treatment up to 12 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov