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LUME BioNIS: a Biomarker Study in Patients With NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02671422
Recruitment Status : Active, not recruiting
First Posted : February 2, 2016
Last Update Posted : February 22, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.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®.

Condition or disease
Carcinoma, Non-Small-Cell Lung

Detailed Description:

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Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional Biomarker Study in Patients With Non-Small Cell Lung Cancer (NSCLC) of Adenocarcinoma Tumour Histology Eligible for Treatment With Vargatef® According to the Approved Label.
Actual Study Start Date : March 9, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: up to 49 months ]

Secondary Outcome Measures :
  1. Disease progression [ Time Frame: 9 month ]

Biospecimen Retention:   Samples With DNA
FPE tumour tissue and one blood sample. A buccal swab may replace the blood sample if not available.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
NSCLC patients under Vargatef® treatment according to label

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02671422

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Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim Identifier: NCT02671422     History of Changes
Other Study ID Numbers: 1199.223
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases