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

IMMUNOBLOOD: Perspective Study for the Evaluation of Anti-Inhibitory Checkpoint Antibody Development in Patients Undergoing Immunotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC

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.

• Study Type: Observational
• Enrollment (Estimated): 270

Contacts and Locations

• Study Contact: Name: Federico FC Cappuzzo, PI; Phone Number: +390544285206; Email: federico.cappuzzo@ifo.it
• Study Contact Backup: Name: Grisel GM Maver Militello, Monitor; Phone Number: 0652662724; Email: grisel.mavermilitello@ifo.it

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 000144
      • Enrolling by invitation
      • Istituto Tumori Regina Elena
    • Roma, RM, Italy, 00128
      • Recruiting
      • Istituto Tumori Regina Elena
      • Contact: Grisel GM Maver Militello, S.C; Phone Number: 0652662724; Email: grisel.mavermilitello@ifo.it
      • Contact: carlo CP Ponzo, S.C; Phone Number: 0652662724; Email: carlo.ponzo@ifo.it
      • Sub-Investigator: Lorenza LL Landi, Dott.ssa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of Anti-Checkpoint Inhibitor Antibodies in Plasma of Participants Receiving Treatment	Detection of anti-checkpoint inhibitors antibodies in plasma	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.

Collaborators and Investigators

• Sponsor: Fondazione Ricerca Traslazionale
• Investigators: Principal Investigator: Federico FC Cappuzzo, PI, IRCCS Ist. Naz. Tum. Regina Elena

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Estimated): September 10, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: immunotherapy
• Other Study ID Numbers: IMMUNOBLOOD; RS1466/21(2477) (Other Identifier: Fondazionefort)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No