Investigating immune responses in lung cancer patients receiving immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Istituto Tumori Regina Elena
  Roma, Rm, Italy Recruiting
• Istituto Tumori Regina Elena
  Roma, Rm, Italy Enrolling by invitation

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.