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

NCT06823401 | Recruiting DMC

• 2 other identifiers: IMMUNOBLOODRS1466/21(2477)
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 2

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.

Conditions

NSCLC

Keywords

immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Ricerca Traslazionale: lead

Study Sites (2)

Istituto Tumori Regina Elena

Roma, RM, 000144, Italy

ENROLLING BY INVITATION

Istituto Tumori Regina Elena

Roma, RM, 00128, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma levels of anti-drug antibodies will be analyzed prior trial therapy and prior each next cycle until disease progression. Blood sample (6 ml) will be collected by enrolled patients and spinned at 1500 rpm (within 2/3 24 hours the withdrawal) at Regina Elena National Cancer Institute (IRE). In particular, plasma levels of anti-drug antibodies will be assessed by using enzyme immunoassay (ELISA). The method employs the principle of competitive ELISA, allowing quantification of anti-drug antibodies (expressed in µg/ml), according to an internal standard curve.

Study Officials

• Federico FC Cappuzzo, PI

  IRCCS Ist. Naz. Tum. Regina Elena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico FC Cappuzzo, PI

CONTACT

+390544285206; federico.cappuzzo@ifo.it

Grisel GM Maver Militello, Monitor

CONTACT

0652662724; grisel.mavermilitello@ifo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 12, 2025
• Study Start: May 20, 2021
• Primary Completion (Estimated): September 10, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

IT (2)