Research question and objectives: To explore whether genetic/genomic markers (alone or combined with clinical covariates) could be used to predict OS in NSCLC patients treated with Vargatef® according to the approved label.
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overall Survival (OS). OS is defined as the time from start of entering the
study to time of death (irrespective of reason).
Secondary outcome
Time since start of first line therapy until start of Vargatef® therapy
Time since start of first line therapy until start of Vargatef® therapy is
divided into 2 subgroups as follows:
• *Late progression group*: time from start of first line therapy until start
of Vargatef® >=9 months (T>=9)
• *Early progression group*: time from start of first line therapy until start
of Vargatef® <9 months (T<9)
Background summary
At present there are no approved predictive tumour- or serum-derived biomarkers
guiding usage of anti-angiogenic therapies in patients with adenocarcinoma of
NSCLC. Consequently, EMA requested BI to search for potential predictive
biomarkers in NSCLC patients eligible for treatment with Vargatef®. The
objective of this NIS is to examine whether genetic/genomic markers (alone or
combined with clinical covariates) could be used to predict OS in NSCLC
patients eligible for treatment with Vargatef®. The investigations in this
study are exploratory in nature and considered to be hypothesis generating. The
results from these investigations may help to expand our understanding of the
disease and the response to Vargatef®.
Study objective
Research question and objectives: To explore whether genetic/genomic markers
(alone or combined with clinical covariates) could be used to predict OS in
NSCLC patients treated with Vargatef® according to the approved label.
Study design
Non-interventional, multi-country, multi-site study based on newly collected
data in patients that are assigned to receive Vargatef® as part of the routine
treatment according to the approved label for the first time (new users
design). Patients will be followed up until death, lost to follow-up,
withdrawal of consent, or until required number of OS events has occurred,
whichever occurs first.
Study burden and risks
Not applicable
Comeniusstraat 6
Alkmaar 1817 MS
NL
Comeniusstraat 6
Alkmaar 1817 MS
NL
Listed location countries
Age
Inclusion criteria
- Women and men with locally advanced, metastatic or locally recurrent NSCLC with histology of adenocarcinoma
- Vargatef is initiated and administered in accordance with the SPC
- Available fixed and paraffin embedded (FPE) tumour tissue routinely obtained at diagnosis and/or re-biopsy before the initiation of the first line treatment (either block or slides, minimum of 10 slides and up to 20 slides if possible at 5 um thickness).
Exclusion criteria
- Any contraindication to Vargatef or docetaxel as specified in their respective labels
- Vargatef initiated from more than 7 days prior to inclusion in this NIS
- Patients participating simultaneously in another NIS or a clinical trial
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55329.072.16 |
| Other | nog niet bekend |