Non-small Cell Lung Cancer (NSCLC)
Conditions
Keywords
Non-small cell lung cancer (NSCLC)
Brief summary
The purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of first-line nivolumab plus ipilimumab treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) in Italy
Interventions
As per product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | Up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | Up to 5 years |
| Overall response rate (ORR) | Up to 5 years |
| Best overall response (BOR) | Up to 5 years |
| Best overall response rate (BORR) | Up to 5 years |
| Tumor response to treatment as classified by the treating physician and Response Evaluation Criteria in Solid Tumors (RECIST) criteria | Up to 5 years |
| Duration of response (DOR) | Up to 5 years |
| Time to response (TTR) | Up to 5 years |
| European Quality of Life-5 Dimensions (EQ-5D) Score | Baseline and up to 5 years |
| Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) results | Baseline and up to 5 years |
| Treatment regimen | Up to 5 years |
| Stage IV or recurrent, not previously treated, squamous and non-squamous NSCLC as confirmed by histology and/or cytology test results | Baseline |
| Number of participants discontinuing treatment | Up to 5 years |
| Management of Adverse Events (AEs) | Up to 5 years |
| Participant socio-demographic characteristics | Baseline and up to 5 years |
| Participant clinical characteristics | Baseline and up to 5 years |
Countries
Italy
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed