Study Investigating Anti-drug Antibodies in NSCLC Patients Exposed to Checkpoint Inhibitors (IMB)

NCT ID: NCT06823401

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2025-12-31

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.

Conditions

NSCLC

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Ricerca Traslazionale

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Federico FC Cappuzzo, PI

Role: PRINCIPAL_INVESTIGATOR

IRCCS Ist. Naz. Tum. Regina Elena

Locations

Istituto Tumori Regina Elena

Roma, RM, Italy

Site Status: ENROLLING_BY_INVITATION

Istituto Tumori Regina Elena

Roma, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Federico FC Cappuzzo, PI

Role: CONTACT

federico.cappuzzo@ifo.it

+390544285206

Grisel GM Maver Militello, Monitor

Role: CONTACT

grisel.mavermilitello@ifo.it

0652662724

Facility Contacts

Grisel GM Maver Militello, Monitor

Role: primary

grisel.mavermilitello@ifo.it

0652662724

Raffaella RV Veneziano, S.C

Role: backup

raffaella.veneziano@ifo.it

0652662724

Other Identifiers

RS1466/21(2477)

Identifier Type: OTHER

Identifier Source: secondary_id

IMMUNOBLOOD

Identifier Type: -

Identifier Source: org_study_id