Clinical trial NCT06823401: Study Investigating Anti-drug Antibodies in NSCLC Patients Exposed to Checkpoint Inhibitors (IMB)
Official title: IMMUNOBLOOD: Perspective Study for the Evaluation of Anti-Inhibitory Checkpoint Antibody Development in Patients Undergoing Immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC
Keywords: immunotherapy
Lead sponsor: Fondazione Ricerca Traslazionale
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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

Brief summary: 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.

Detailed description: Prospective study aimed at evaluating the development of anti-drug antibodies in patients with NSCLC treated with immune checkpoint inhibitors, either as monotherapy or in combination, and the correlation between the presence of anti-drug antibodies, treatment efficacy, and the occurrence of adverse drug reactions.

Primary objective:

To assess whether patients treated with checkpoint inhibitors as single agent or in combination with other checkpoint inhibitors or chemotherapy develop anti-drug antibodies during the course of treatment Secondary objective: To assess whether development of anti-drug antibodies is associated with response, duration of response, PFS, OS, toxicity For each eligible patient, a blood sample (6 ml) will be collected before the start of therapy and before each treatment cycle until disease progression or the completion of the planned cycles. The tests and procedures the patient will undergo are all considered routine and part of standard medical care, so they do not entail any additional risks associated with participation in this study.

Eligibility criteria: Inclusion Criteria:

* 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)
* Patient compliance to trial procedures
* Age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Detection of Anti-Checkpoint Inhibitor Antibodies in Plasma of Participants Receiving Treatment
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Istituto Tumori Regina Elena
state: RM
city: Roma
country: Italy
facility: Istituto Tumori Regina Elena
state: RM
Study officials:
affiliation: IRCCS Ist. Naz. Tum. Regina Elena
name: Federico FC Cappuzzo, PI
role: PRINCIPAL_INVESTIGATOR
References: