LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02231164
• Date of registration: 02/09/2014
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
• Scientific title: Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral Nintedanib Plus Docetaxel Therapy Compared to Placebo Plus Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent, Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy
• Date of first enrolment: October 2014
• Target sample size: 12
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02231164
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
• Phase: Phase 3

Countries of recruitment

Australia, Canada, Egypt, Georgia, Lebanon, Puerto Rico, Serbia, Singapore, South Africa, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion criteria:

- Male or female patients of at least 18 years of age

- Histologically confirmed, adenocarcinoma of the lung, after failure of first line
platinum-based chemotherapy.

Exclusion criteria:

- More than one prior line of chemotherapy (i.e., 2nd or 3rd line chemotherapy) for
advanced and/or metastatic (stage III B or IV NSCLC) or recurrent disease.

- Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR)
mutation or anaplastic lymphoma kinase (ALK) translocation

- Previous therapy with other vascular endothelial growth factor (VEGF) or VEGFR
inhibitors (other than bevacizumab) or docetaxel for the treatment of NSCLC at any
time

- Prior monotherapy with an EGFR inhibitor except as maintenance therapy



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Carcinoma, Non-Small-Cell Lung

Intervention(s)

Drug: docetaxel

Drug: placebo

Drug: nintedanib

Primary Outcome(s)

Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 [Time Frame: Up to 6 months.]

Secondary ID(s)

1199.128

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/02/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02231164