NSCLCIMBNCT06823401
Study Investigating Anti-drug Antibodies in NSCLC Patients Exposed to Checkpoint Inhibitors (IMB)
An observational study of NSCLC, run by Fondazione Ricerca Traslazionale at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- How many people
- 270 participants
- Where
- 2 sitesItaly
- Study dates
- 20 May 2021to 31 Dec 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Enrolling by invitation
Istituto Tumori Regina Elena
Roma, RM, 000144
- Recruiting
Istituto Tumori Regina Elena
Roma, RM, 00128
Grisel GM Maver Militello, S.C, 0652662724, grisel.mavermilitello@ifo.it
carlo CP Ponzo, S.C, 0652662724, carlo.ponzo@ifo.it
About this study
Official title: 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.
Read the 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
- Keywords
- immunotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Anti-Checkpoint Inhibitor Antibodies in Plasma of Participants Receiving Treatment
Detection of anti-checkpoint inhibitors antibodies in plasma
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start20 May 2021
- Primary completion10 Sep 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fondazione Ricerca Traslazionale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federico FC Cappuzzo, PI, Principal investigator, IRCCS Ist. Naz. Tum. Regina Elena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823401
- Sponsor's protocol ID
- IMMUNOBLOOD
- Other IDs
- RS1466/21(2477)
- Acronym
- IMB
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMMUNOBLOOD: Perspective Study for the Evaluation of Anti-Inhibitory Checkpoint Antibody Development in Patients Undergoing Immunotherapy
- ClinicalTrials.gov ID
- NCT06823401
- Acronym / sponsor ID
- IMB / IMMUNOBLOOD
- Conditions
- NSCLC
- Keywords
- immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Fondazione Ricerca TraslazionaleUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of Anti-Checkpoint Inhibitor Antibodies in Plasma of Participants Receiving Treatment
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.
Detection of anti-checkpoint inhibitors antibodies in plasma
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Federico FC Cappuzzo, PI principal investigator
IRCCS Ist. Naz. Tum. Regina Elena
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Fondazione Ricerca Traslazionale at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico FC Cappuzzo, PI (+390544285206, federico.cappuzzo@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Anti-Checkpoint Inhibitor Antibodies in Plasma of Participants Receiving Treatment (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.