Clinical Confirmation LUME-BioNIS:
Non-interventional Nintedanib Biomarker Study
•
100 study sites in Europe.
AE = adverse event; BID = twice daily; IV = intravenous; OS = overall survival; PD = progressive disease.
*75 mg/m
2
IV, on Day 1 of every 3-week cycle
Treatment according to label
Inclusion
•
Eligible for nintedanib + docetaxel,
according to label
•
Consent to provide sample of
archived tumour tissue
, and one
blood sample or buccal swab if
collected
PD/AE
Nintedanib
200 mg BID
+ docetaxel*
N=300
Efficacy measurement:
OS
Study objective
:
To examine whether there are
genetic/genomic markers
(alone or combined with clinical covariates) that
can predict OS
in patients
with advanced
adenocarcinoma
eligible for treatment with nintedanib +
docetaxel according to the approved label
