Real-Life Study With Nivolumab (BMS-936558) in Advanced NSCLC Patients After Prior Chemotherapy (ENLARGE-Lung)

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Non-Small Cell Lung Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02910999

CA209-580

Details and patient eligibility

About

This study intends to describe the real-life effectiveness and safety of nivolumab in advanced NSCLC patients in Germany, as well as the patient profile, pattern of use and the quality of life.

Enrollment: 868 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC, Stage IIIB/Stage IV
• Decision to initiate a treatment with Nivolumab for the first time already undertaken by physician
• Males and Females, ≥18 years of age

Exclusion criteria

• Current primary diagnosis of a cancer other than advanced NSCLC. Example: A cancer other than NSCLC that requires systemic or other treatment.
• Pre-treatment with Nivolumab and/or Ipilimumab (pre-treatment with checkpoint-inhibitors other than Nivolumab and Ipilimumab, and Tyrosine Kinase Inhibitors(TKIs) is allowed)
• Current participation in an interventional clinical trial for treatment of NSCLC. (Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. For blinded studies, the treatment administered needs to be known)

Other protocol defined inclusion/exclusion criteria could apply

Trial design

868 participants in 2 patient groups

NSCLC patients with squamous tumor histology

NSCLC patients with non-squamous tumor histology