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NCT02671422

LUME BioNIS: a Biomarker Study in Patients With NSCLC

Completed Results posted Last updated 24 September 2020
What this trial tests

trial in Carcinoma, Non-Small-Cell Lung in 260 participants. Completed in 3 September 2019.

Timeline
9 March 2016
Primary endpoint
3 September 2019
3 September 2019

Quick facts

Lead sponsorBoehringer Ingelheim
StatusCompleted
Study typeOBSERVATIONAL
Enrollment260
Start date9 March 2016
Primary completion3 September 2019
Estimated completion3 September 2019
Sites71 locations across Denmark, Italy, Netherlands, Greece, Belgium, Austria, Sweden, United Kingdom

Conditions studied

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Overall Survival (OS) Event Primary · 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 know

GroupValue95% CI
200mg Vargatef®206

Adverse events — posted to ClinicalTrials.gov

Time frame: From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

200mg Vargatef®
Serious: 127/257 (49%)
Deaths: 209/260

Serious adverse events (82 terms)

ReactionSystem200mg Vargatef®
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)
PneumoniaInfections and infestations
Febrile neutropeniaBlood and lymphatic system disorders
DiarrhoeaGastrointestinal disorders
VomitingGastrointestinal disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
Pulmonary embolismRespiratory, thoracic and mediastinal disorders
NauseaGastrointestinal disorders
Performance status decreasedGeneral disorders
HyponatraemiaMetabolism and nutrition disorders
Pleural effusionRespiratory, thoracic and mediastinal disorders
Respiratory failureRespiratory, thoracic and mediastinal disorders
NeutropeniaBlood and lymphatic system disorders
Cardiac arrestCardiac disorders
Cardio-respiratory arrestCardiac disorders
TachycardiaCardiac disorders
PyrexiaGeneral disorders
CholecystitisHepatobiliary disorders
Neutropenic sepsisInfections and infestations
SepsisInfections and infestations
C-reactive protein increasedInvestigations
DehydrationMetabolism and nutrition disorders
AgranulocytosisBlood and lymphatic system disorders
LeukopeniaBlood and lymphatic system disorders
NeutrophiliaBlood and lymphatic system disorders
Other adverse events (5 terms — click to expand)

ReactionSystem200mg Vargatef®
DiarrhoeaGastrointestinal disorders
NauseaGastrointestinal disorders
FatigueGeneral disorders
VomitingGastrointestinal disorders
Decreased appetiteMetabolism and nutrition disorders

Most-reported serious reactions: Malignant neoplasm progression, Pneumonia, Febrile neutropenia, Diarrhoea, Vomiting, Dyspnoea, Pulmonary embolism, Nausea.

Data from ClinicalTrials.gov NCT02671422 adverse events section.

Sponsor's own description

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®.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A non-interventional biomarker study in patients with adenocarcinoma of the lung treated with nintedanib plus docetaxel following progression on chemotherapy and/or immunotherapy: LUME-BioNIS.
    Reck M, Syrigos K, Miliauskas S, Van't Westeinde SC, et al · · 2024 · cited 1× · PMID 39830745 · DOI 10.21037/tlcr-24-326

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Other recruiting trials for Carcinoma, Non-Small-Cell Lung

Currently open trials in the same condition.

Other Boehringer Ingelheim trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02671422.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing