LUME BioNIS: a Biomarker Study in Patients With NSCLC

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT02671422
• Lead Sponsor: 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®.

Detailed Description

Purpose:

Study Timeline

• Study First Submitted: 2016-01-29
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-02
• Study Start: 2016-03-09
• Primary Completion: 2019-09-03
• Study Completion: 2019-09-03
• Status Verified: 2020-09
• Results First Submitted: 2020-09-02
• Results First Submitted QC: 2020-09-02
• Last Update Submitted: 2020-09-02
• Results First Posted: 2020-09-24
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Overall Survival (OS) Event	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.

Trial Locations

Locations (71)

LK Krems; 🇦🇹 Krems, Austria

AKH - Medical University of Vienna; 🇦🇹 Wien, Austria

Brussels - UNIV Saint-Luc; 🇧🇪 Bruxelles, Belgium

AZ Maria Middelares; 🇧🇪 Gent, Belgium

AZ Sint-Lucas - Campus Sint Lucas; 🇧🇪 Gent, Belgium

Ieper - HOSP Jan Yperman; 🇧🇪 Ieper, Belgium

Liège - HOSP CHR de la Citadelle; 🇧🇪 Liège, Belgium

Charleroi - UNIV CHU de Charleroi; 🇧🇪 Lodelinsart, Belgium

Roeselare - HOSP AZ Delta; 🇧🇪 Roeselare, Belgium

Herlev and Gentofte Hospital; 🇩🇰 Herlev, Denmark

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