LUME BioNIS: a Biomarker Study in Patients With NSCLC

Boehringer Ingelheim

Status: Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Study type: Observational

Funder types: Industry

Identifiers

NCT02671422

1199.223

Details and patient eligibility

About

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®.

Full description

Purpose:

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design