Italian study tracks Real-World success of immunotherapy combo for lung cancer
NCT ID NCT06487156
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is observing how well a combination of two immunotherapy drugs (nivolumab and ipilimumab) works for people with advanced non-small cell lung cancer in Italy. Researchers are collecting data from 404 patients to understand real-world outcomes, side effects, and treatment patterns. The goal is to learn more about how this treatment performs outside of clinical trials.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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404 people
The number who actually took part.
- Started
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Oct 2023
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult patients diagnosed with locally advanced or metastatic non-small cell lung cancer treated with nivolumab plus ipilimumab as first-line treatment
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of stage IV or recurrent NSCLC (histologically or cytologically confirmed stage), without known EGFR- or ALK-alterations * Decision to initiate a first-line treatment with nivolumab plus ipilimumab for the treatment of NSCLC according to the Italy label has been made independently of the study * Patient is at least 18 years of age at time of treatment decision * Patient provided written informed consent to participate in the study Exclusion Criteria: * Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment * Patients with known EGFR- or ALK-alterations * Previous treatment with nivolumab and/or ipilimumab * Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC (but: Patients who have completed their participation in an interventional trial, who are not receiving study drug any more, and who are only followed-up for OS, can be enrolled)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Local Institution - 0001
Naples, 80131, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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