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

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ClinicalTrials.gov Identifier: NCT02231164
Recruitment Status : Terminated
First Posted : September 4, 2014
Results First Posted : February 13, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung
Interventions Drug: docetaxel
Drug: placebo
Drug: nintedanib
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Nintedanib
Hide Arm/Group Description Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Period Title: Overall Study
Started 6 6
Completed 0 0
Not Completed 6 6
Reason Not Completed
Adverse Event             1             1
Lack of Efficacy             4             3
Withdrawal by Subject             1             2
Arm/Group Title Placebo Nintedanib Total
Hide Arm/Group Description Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
Randomised Set: The randomised set included all randomised patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
59.7  (12.2) 63.3  (8.3) 61.5  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
1
  16.7%
2
  33.3%
3
  25.0%
Male
5
  83.3%
4
  66.7%
9
  75.0%
1.Primary Outcome
Title Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1
Hide Description This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease.
Time Frame Up to 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised Set: The randomised set included all randomised patients.
Arm/Group Title Placebo Nintedanib
Hide Arm/Group Description:
Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: Percentage of participants
Yes 66.7 50.0
No 33.3 50.0
Time Frame From first drug administration until 28 days after last drug administration, up to 7 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Nintedanib
Hide Arm/Group Description Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
All-Cause Mortality
Placebo Nintedanib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Nintedanib
Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   3/6 (50.00%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  0/6 (0.00%)  1/6 (16.67%) 
Cardiac disorders     
Atrial fibrillation  1  1/6 (16.67%)  0/6 (0.00%) 
Cardio-respiratory arrest  1  1/6 (16.67%)  0/6 (0.00%) 
Tachycardia  1  1/6 (16.67%)  0/6 (0.00%) 
Infections and infestations     
Clostridium difficile infection  1  1/6 (16.67%)  0/6 (0.00%) 
Pneumonia  1  1/6 (16.67%)  1/6 (16.67%) 
Sepsis  1  0/6 (0.00%)  1/6 (16.67%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  1/6 (16.67%)  0/6 (0.00%) 
Lactic acidosis  1  0/6 (0.00%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain  1  1/6 (16.67%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression  1  2/6 (33.33%)  0/6 (0.00%) 
Metastases to skin  1  0/6 (0.00%)  1/6 (16.67%) 
Vascular disorders     
Orthostatic hypotension  1  1/6 (16.67%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Nintedanib
Affected / at Risk (%) Affected / at Risk (%)
Total   5/6 (83.33%)   6/6 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  2/6 (33.33%)  0/6 (0.00%) 
Leukopenia  1  2/6 (33.33%)  1/6 (16.67%) 
Neutropenia  1  2/6 (33.33%)  3/6 (50.00%) 
Eye disorders     
Lacrimation increased  1  1/6 (16.67%)  1/6 (16.67%) 
Visual impairment  1  0/6 (0.00%)  2/6 (33.33%) 
Gastrointestinal disorders     
Abdominal pain  1  3/6 (50.00%)  2/6 (33.33%) 
Abdominal pain upper  1  0/6 (0.00%)  1/6 (16.67%) 
Diarrhoea  1  3/6 (50.00%)  4/6 (66.67%) 
Dry mouth  1  1/6 (16.67%)  0/6 (0.00%) 
Dyspepsia  1  0/6 (0.00%)  1/6 (16.67%) 
Dysphagia  1  1/6 (16.67%)  0/6 (0.00%) 
Flatulence  1  0/6 (0.00%)  1/6 (16.67%) 
Frequent bowel movements  1  0/6 (0.00%)  1/6 (16.67%) 
Glossodynia  1  1/6 (16.67%)  1/6 (16.67%) 
Haemorrhoids  1  0/6 (0.00%)  1/6 (16.67%) 
Nausea  1  1/6 (16.67%)  5/6 (83.33%) 
Oral pain  1  0/6 (0.00%)  2/6 (33.33%) 
Stomatitis  1  0/6 (0.00%)  1/6 (16.67%) 
Vomiting  1  0/6 (0.00%)  5/6 (83.33%) 
General disorders     
Chest pain  1  0/6 (0.00%)  1/6 (16.67%) 
Chills  1  1/6 (16.67%)  1/6 (16.67%) 
Facial pain  1  0/6 (0.00%)  1/6 (16.67%) 
Fatigue  1  4/6 (66.67%)  3/6 (50.00%) 
Mucosal inflammation  1  1/6 (16.67%)  1/6 (16.67%) 
Oedema peripheral  1  1/6 (16.67%)  0/6 (0.00%) 
Pain  1  2/6 (33.33%)  1/6 (16.67%) 
Polyp  1  0/6 (0.00%)  1/6 (16.67%) 
Pyrexia  1  0/6 (0.00%)  1/6 (16.67%) 
Immune system disorders     
Allergy to arthropod sting  1  0/6 (0.00%)  1/6 (16.67%) 
Seasonal allergy  1  0/6 (0.00%)  1/6 (16.67%) 
Infections and infestations     
Cellulitis  1  1/6 (16.67%)  0/6 (0.00%) 
Pneumonia  1  2/6 (33.33%)  0/6 (0.00%) 
Upper respiratory tract infection  1  0/6 (0.00%)  1/6 (16.67%) 
Investigations     
Breath sounds abnormal  1  0/6 (0.00%)  1/6 (16.67%) 
Weight decreased  1  0/6 (0.00%)  1/6 (16.67%) 
Metabolism and nutrition disorders     
Decreased appetite  1  2/6 (33.33%)  4/6 (66.67%) 
Dehydration  1  0/6 (0.00%)  1/6 (16.67%) 
Hypokalaemia  1  1/6 (16.67%)  1/6 (16.67%) 
Hyponatraemia  1  2/6 (33.33%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/6 (0.00%)  2/6 (33.33%) 
Back pain  1  0/6 (0.00%)  1/6 (16.67%) 
Flank pain  1  0/6 (0.00%)  1/6 (16.67%) 
Muscular weakness  1  1/6 (16.67%)  0/6 (0.00%) 
Musculoskeletal chest pain  1  0/6 (0.00%)  1/6 (16.67%) 
Musculoskeletal pain  1  1/6 (16.67%)  1/6 (16.67%) 
Myalgia  1  1/6 (16.67%)  1/6 (16.67%) 
Pain in extremity  1  1/6 (16.67%)  0/6 (0.00%) 
Nervous system disorders     
Dizziness  1  1/6 (16.67%)  0/6 (0.00%) 
Dysgeusia  1  1/6 (16.67%)  2/6 (33.33%) 
Headache  1  0/6 (0.00%)  1/6 (16.67%) 
Neuropathy peripheral  1  1/6 (16.67%)  3/6 (50.00%) 
Peripheral sensory neuropathy  1  0/6 (0.00%)  1/6 (16.67%) 
Syncope  1  1/6 (16.67%)  0/6 (0.00%) 
Tremor  1  0/6 (0.00%)  1/6 (16.67%) 
Psychiatric disorders     
Anxiety  1  1/6 (16.67%)  0/6 (0.00%) 
Insomnia  1  0/6 (0.00%)  2/6 (33.33%) 
Mood altered  1  1/6 (16.67%)  0/6 (0.00%) 
Renal and urinary disorders     
Proteinuria  1  1/6 (16.67%)  1/6 (16.67%) 
Urinary tract obstruction  1  1/6 (16.67%)  0/6 (0.00%) 
Reproductive system and breast disorders     
Erectile dysfunction  1  0/6 (0.00%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/6 (33.33%)  1/6 (16.67%) 
Dysphonia  1  1/6 (16.67%)  1/6 (16.67%) 
Dyspnoea  1  3/6 (50.00%)  2/6 (33.33%) 
Epistaxis  1  0/6 (0.00%)  1/6 (16.67%) 
Haemoptysis  1  0/6 (0.00%)  1/6 (16.67%) 
Nasal congestion  1  0/6 (0.00%)  1/6 (16.67%) 
Oropharyngeal pain  1  0/6 (0.00%)  1/6 (16.67%) 
Productive cough  1  1/6 (16.67%)  0/6 (0.00%) 
Respiratory distress  1  0/6 (0.00%)  1/6 (16.67%) 
Upper-airway cough syndrome  1  1/6 (16.67%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  3/6 (50.00%)  2/6 (33.33%) 
Erythema  1  0/6 (0.00%)  1/6 (16.67%) 
Nail discolouration  1  0/6 (0.00%)  1/6 (16.67%) 
Nail ridging  1  1/6 (16.67%)  0/6 (0.00%) 
Pain of skin  1  1/6 (16.67%)  0/6 (0.00%) 
Pruritus  1  1/6 (16.67%)  0/6 (0.00%) 
Rash  1  0/6 (0.00%)  1/6 (16.67%) 
Vascular disorders     
Hypertension  1  1/6 (16.67%)  0/6 (0.00%) 
Hypotension  1  0/6 (0.00%)  2/6 (33.33%) 
Phlebitis  1  0/6 (0.00%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
The sponsor cancelled this trial prematurely. Thus, enrollment for 1199.128 was significantly less than what was planned (800 planned vs. 12 entered). Therefore, the objectives of this study could not be fully assessed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02231164    
Other Study ID Numbers: 1199.128
First Submitted: September 2, 2014
First Posted: September 4, 2014
Results First Submitted: December 20, 2016
Results First Posted: February 13, 2017
Last Update Posted: March 21, 2017