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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 : Completed
First Posted : February 2, 2016
Results First Posted : September 24, 2020
Last Update Posted : September 24, 2020
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
Actual Enrollment : 260 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
Actual Primary Completion Date : September 3, 2019
Actual Study Completion Date : September 3, 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] May 9, 2019
Statistical Analysis Plan  [PDF] March 28, 2019

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02671422    
Other Study ID Numbers: 1199.223
First Posted: February 2, 2016    Key Record Dates
Results First Posted: September 24, 2020
Last Update Posted: September 24, 2020
Last Verified: September 2020
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