AN OBSERVATIONAL STUDY OF EFFECTIVENESS AND SAFETY OF THE FIRST LINE NIVOLUMAB PLUS IPILIMUMAB WITH OR WITHOUT CHEMOTHERAPY FOR ADVANCED / RECURRENT NON-SMALL CELL LUNG CANCER IN JAPAN (LIGHT-NING) - LIGHT-NING

Bristol-Myers Squibb K.K. Ono Pharmaceutical CO.,LTD.0 sites529 target enrollmentMay 31, 2021

Overview

No summary available.

Registry

who.int

Start Date

May 31, 2021

End Date

December 31, 2025

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

Bristol-Myers Squibb K.K. Ono Pharmaceutical CO.,LTD.

•For entry into the study, the following criteria MUST NOT be met at the time of informed consent: 1\. In patients with non\-squamous histology, patients who are confirmed to be positive for EGFR gene mutation or ALK fusion gene for which EGFR tyrosine kinase inhibitor or ALK tyrosine kinase inhibitor is indicated. 2\. Patients who had antineoplastic treatment as first\-line treatment of advanced or recurrent NSCLC prior to initiation of nivolumab plus ipilimumab with or without chemotherapy. However, patients who correspond to a) or b) below will be included in this study. a) Prior perioperative chemotherapy or Stage III chemoradiotherapy or durvalumab combination chemoradiotherapy. b) Patients who are received or have received bisphosphonates or denosumab for bone metastasis 3\. Patients who initiated treatment with nivolumab plus ipilimumab and added chemotherapy from the second course onwards. 4\. Patients who received investigational anti\-tumor drug in clinical trial after being diagnosed with NSCLC 5\. Other patients who are judged by the investigators to be inappropriate for enrollment in this study