ENLARGE-Lung: Two-Year Follow-up of Real-World Patients with Locally Advanced or Metastatic (Stage IIIB/IV) Squamous and Non-Squamous Non-Small Cell Lung Cancer (NSCLC) from a National, Prospective, Non-Interventional Study (NIS ENLARGE) of Nivolumab after Prior Chemotherapy in Germany

Purpose: In two registrational trials, nivolumab showed overall survival (OS) benefit versus docetaxel in pretreated locally advanced or metastatic NSCLC. These results have been confirmed by initial data disclosure of the German NIS ENLARGE. Here we report mature OS data from the first 300 patients enrolled in the trial.

Methods: 882 patients with pretreated, locally advanced or metastatic NSCLC recruited from 79 cancer care facilities in Germany will be followed for a period of 5 years from initiation of nivolumab until death, withdrawal of consent, loss of follow-up/record or end of study. The primary endpoint is OS. Baseline characteristics are reported using descriptive statistics. OS from the time of first nivolumab dose is estimated using the Kaplan-Meier method. Study was initiated in July 2016.

Results: With the data cut off on July 31st 2019, interim data of the first 300 patients from the ENLARGE study describe baseline characteristics and OS of patients with a minimum follow-up of 25 months. We report OS and response rates for the total population, by histology and other subgroups of interest (biomarker, ECOG Performance Status, elderly, metastases).

Conclusions: Real world data provide complementary information about special patient populations underrepresented in interventional clinical trials (elderly, poor performance status, comorbidities) and outcomes of treatment with nivolumab in accordance with the market authorization approval in Germany.