Clinical trial · Observational
A Study of Nivolumab, Ipilimumab, and Chemotherapy in Participants With Non-small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to describe the real-world patient and disease characteristics of metastatic non-small cell lung cancer (NSCLC) participants initiated on first-line (1L) treatment with nivolumab, ipilimumab, and platinum-based chemotherapy (NIVO/IPI/PBC), in the overall study population and the subpopulations per histological subtype of NSCLC and PD-L1 expression level.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Participants with metastatic NSCLC initiated on 1L treatment with NIVO/IPI/PBC
Primary outcomes (11)
- measure
- Baseline participant and disease characteristics of interest in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level
- timeFrame
- Baseline
- measure
- Number of NIVO/IPI/PBC doses administered in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level
- timeFrame
- Up to 157 weeks
- measure
- Time interval between infusions in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level
- timeFrame
- Up to 157 weeks
- measure
- Rate of dose modifications in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available