Investigating immune responses in lung cancer patients receiving immunotherapy
IMMUNOBLOOD: Perspective Study for the Evaluation of Anti-Inhibitory Checkpoint Antibody Development in Patients Undergoing Immunotherapy
This study looks at how the immune system responds in lung cancer patients receiving immunotherapy to see if these responses affect how well the treatment works and any side effects they might have.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Ricerca Traslazionale Academic / other |
| Drugs / interventions | pembrolizumab, atezolizumab, nivolumab, durvalumab, ipilimumab, chemotherapy, immunotherapy |
| Locations | 2 sites (Roma, RM and 1 other locations) |
| Trial ID | NCT06823401 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with non-small cell lung cancer (NSCLC) who are treated with immune checkpoint inhibitors. It aims to evaluate the development of anti-drug antibodies during treatment and how these antibodies correlate with treatment efficacy and adverse reactions. Blood samples will be collected from participants before therapy and at each treatment cycle to monitor these immune responses. The study seeks to enhance understanding of how the immune system interacts with cancer therapies, potentially leading to improved treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed NSCLC who are eligible for treatment with checkpoint inhibitors.
Not a fit: Patients who have previously received checkpoint inhibitors or are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better personalized treatment approaches for NSCLC patients receiving immunotherapy.
How similar studies have performed: Other studies have shown promising results in understanding immune responses to checkpoint inhibitors, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Roma, RM and 1 other locations
- Istituto Tumori Regina Elena — Roma, Rm, Italy (Enrolling_by_invitation)
- Istituto Tumori Regina Elena — Roma, Rm, Italy (Recruiting)
Study contacts
- Principal investigator: Federico FC Cappuzzo, PI — IRCCS Ist. Naz. Tum. Regina Elena
- Study coordinator: Federico FC Cappuzzo, PI
- Email: federico.cappuzzo@ifo.it
- Phone: +390544285206
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.