LUME BioNIS: a Biomarker Study in Patients With NSCLC
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At present there are no approved predictive tumour- or serum-derived biomarkers guiding usage of anti-angiogenic therapies in patients with adenocarcinoma of NSCLC.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®.
Number of Participants With Overall Survival (OS) Event [ Time Frame: From start of entering the study until death or last contact date, up to 42 months. ]
Overall survival (OS) was defined as the time from start of entering the study to time of death. For the analysis of overall survival, participants were censored at the date of the last contact if the physician was no longer able to contact a participants or caregiver, and the vital status could not otherwise be determined. Enrolled participants who never received the combination therapy of docetaxel and Vargatef® were censored on the day of enrolment.
Calculation of OS:
For participants with known date of death: OS [days] = date of death - date of treatment start + 1 For participants known to be alive by the end of the study or at follow-up visit: OS (censored) [days] = date of last contact when the Patient was known to be alive - date of treatment start + 1.
Biospecimen Retention: Samples With DNA
FPE tumour tissue and one blood sample. A buccal swab may replace the blood sample if not available.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
NSCLC patients under Vargatef® treatment according to label
Age = 18 years.
Women and men with locally advanced, metastatic or locally recurrent NSCLC with histology of adenocarcinoma.
Signed and dated written informed consent.
Vargatef ® is initiated and administered in accordance with the SPC.
Available fixed and paraffin embedded (FPE) tumour tissue routinely obtained at diagnosis and/or at 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 5µm thickness).
Any contraindication to Vargatef® or docetaxel as specified in their respective labels.
Vargatef® initiated more than 7 days prior to inclusion in this NIS.
Patients participating simultaneously in a clinical trial.