Evaluating Ipilimumab and Nivolumab for Advanced Lung Cancer
FINN (First-line Ipilimumab + Nivolumab in NSCLC): An Italy, Nationwide, Prospective, Observational, Multicenter Study in Patients With First-line Nivolumab Plus Ipilimumab Therapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Bristol-Myers Squibb · NCT06487156
This study is testing how well the combination of two cancer drugs, nivolumab and ipilimumab, works for people in Italy with advanced lung cancer who have chosen to start this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb (industry) |
| Drugs / interventions | nivolumab, ipilimumab |
| Locations | 1 site (Napoli) |
| Trial ID | NCT06487156 on ClinicalTrials.gov |
What this trial studies
This study aims to collect and analyze real-world data on the outcomes, patient characteristics, safety profile, and treatment patterns associated with the first-line use of nivolumab plus ipilimumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in Italy. It focuses on patients who have made an independent decision to initiate this treatment. The study will provide insights into how these therapies perform in a real-world setting, beyond controlled clinical trials.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with stage IV or recurrent NSCLC who do not have known EGFR or ALK alterations and are starting first-line treatment with nivolumab plus ipilimumab.
Not a fit: Patients with other primary cancers requiring treatment, known EGFR or ALK alterations, or those previously treated with nivolumab and/or ipilimumab will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of treatment effectiveness and safety for patients with advanced NSCLC, potentially leading to improved patient outcomes.
How similar studies have performed: While this study focuses on real-world data collection, similar studies evaluating the effectiveness of nivolumab and ipilimumab have shown promising results in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Napoli
- Istituto Nazionale Tumori - IRCCS Fondazione G.Pascale — Napoli, Italy (RECRUITING)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: +1 855-907-3286
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.
Conditions: Non-small Cell Lung Cancer, Non-small cell lung cancer