Examining the characteristics of patients with metastatic non-small cell lung cancer receiving specific treatments
A Non-interventional, Multicenter, Prospective stUdy to Record Treatment patteRns of nivOlumab+Ipilimumab+chemotheRapy Combination as First Line treAtment of Metastatic NSCLC in Routine Clinical Practice in Greece - the 'AURORA' Study
This study is looking to see how well a combination of nivolumab, ipilimumab, and chemotherapy works for people with advanced non-small cell lung cancer and what their experiences are with this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | nivolumab, ipilimumab, chemotherapy |
| Locations | 1 site (Athens) |
| Trial ID | NCT05599685 on ClinicalTrials.gov |
What this trial studies
This study aims to gather real-world data on patients with metastatic non-small cell lung cancer (NSCLC) who are starting first-line treatment with a combination of nivolumab, ipilimumab, and platinum-based chemotherapy. It will analyze patient and disease characteristics, focusing on different histological subtypes of NSCLC and levels of PD-L1 expression. The study will include participants who have already begun treatment and will track their outcomes and responses. This observational approach will help to better understand the effectiveness and applicability of this treatment regimen in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are individuals with metastatic NSCLC who have not had prior treatment and do not have specific genetic mutations.
Not a fit: Patients with other active cancers requiring treatment or those who have not started the specified treatment regimen will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of nivolumab, ipilimumab, and chemotherapy for treating metastatic NSCLC, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy and chemotherapy combinations in treating NSCLC, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with histologically- or cytologically-confirmed diagnosis of metastatic NSCLC (of any histological subtype) whose tumors have no sensitizing EGFR mutation or ALK translocation. * Participants who have been initiated on 1L treatment with NIVO/IPI/PBC (nivolumab combined with ipilimumab and 2 cycles of PBC) as per the products' Summary of Product Characteristics (SmPC) prior to informed consent obtainment, and for whom the treatment regimen is ongoing and no more than one nivolumab infusion has been administered from treatment initiation to obtaining the signed informed consent. * Participants for whom the decision to prescribe treatment with NIVO/IPI/PBC has been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the participant in the current study. Exclusion Criteria: * Participants with a current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment. * Participants who have been treated with any prior systemic therapy in the metastatic setting of NSCLC. * Participants who are currently receiving or are planned to receive treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to NIVO/IPI/PBC therapy initiation.
Where this trial is running
Athens
- Local Institution - 0001 — Athens, Greece (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 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.