LUX-Lung 6: A Randomized, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
Phase of Trial: Phase III
Latest Information Update: 23 Mar 2018
At a glance
- Drugs Afatinib (Primary) ; Cisplatin; Gemcitabine
- Indications Adenocarcinoma; Non-small cell lung cancer
- Focus Registrational; Therapeutic Use
- Acronyms LUX-Lung 6
- Sponsors Boehringer Ingelheim Pharmaceuticals
- 23 Mar 2018 Results (n=1312) assessing the value of early depth of response in predicting long-term outcome in EGFR-mutant lung cancer using data of patients those with either EGFR mutation exon 19 deletion or exon 21 L858R mutations from five phase III randomized trials EURTAC, IPASS, ENSURE, LUX-Lung 3, and LUX-Lung 6, published in the Journal of Thoracic Oncology.
- 16 Jan 2018 According to a Boehringer Ingelheim media release, based on a pooled analysis of LUX-Lung 2, LUX-Lung 3 and LUX-Lung 6 studies the U.S. Food and Drug Administration has approved a supplemental New Drug Application for Gilotrif (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test. The FDA granted Priority Review status to the application.
- 21 Dec 2017 Status changed from active, no longer recruiting to completed.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History