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Lume Lung 2 : Nintedanib Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00806819
First received: December 10, 2008
Last updated: November 14, 2014
Last verified: November 2014
Results First Received: November 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Interventions: Drug: Pemetrexed
Drug: Folic Acid
Drug: Nintedanib
Drug: Nintedanib plus pemetrexed

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nintedanib Plus Pemetrexed Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion.
Placebo Plus Pemetrexed Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion.

Participant Flow:   Overall Study
    Nintedanib Plus Pemetrexed     Placebo Plus Pemetrexed  
STARTED     353 [1]   360 [1]
COMPLETED     7 [2]   2 [2]
NOT COMPLETED     346     358  
progressive disease (modified RECIST )                 217                 216  
Worsening or AE of underlying disease                 18                 25  
Other AE                 38                 40  
Protocol Violation                 9                 4  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 32                 29  
Not treated                 6                 3  
Reasons other than stated above                 25                 41  
[1] randomised patients
[2] On-treatment at analysis cut-off date (15 February 2013)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomised set uncut (RS): all patients who were randomised whether patients had received study treatment or not. Patients were allocated to the treatment groups as randomised, regardless of the actual medication taken.

Reporting Groups
  Description
Nintedanib Plus Pemetrexed Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion.
Placebo Plus Pemetrexed Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion.
Total Total of all reporting groups

Baseline Measures
    Nintedanib Plus Pemetrexed     Placebo Plus Pemetrexed     Total  
Number of Participants  
[units: participants]
  353     360     713  
Age  
[units: years]
Mean ± Standard Deviation
  59.2  ± 10.3     58.7  ± 10.9     59.0  ± 10.6  
Gender  
[units: participants]
     
Female     158     152     310  
Male     195     208     403  



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS) as Assessed by Central Independent Review   [ Time Frame: From randomisation until cut-off date 9 July 2012 ]

2.  Secondary:   Overall Survival (Key Secondary Endpoint)   [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

3.  Secondary:   Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review   [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

4.  Secondary:   Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator   [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

5.  Secondary:   Objective Tumor Response   [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

6.  Secondary:   Duration of Confirmed Objective Tumour Response   [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

7.  Secondary:   Time to Confirmed Objective Tumour Response   [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

8.  Secondary:   Disease Control   [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

9.  Secondary:   Duration of Disease Control   [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

10.  Secondary:   Change From Baseline in Tumour Size   [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

11.  Secondary:   Clinical Improvement.   [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

12.  Secondary:   Quality of Life (QoL)   [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

13.  Secondary:   Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide   [ Time Frame: Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3 ]

14.  Secondary:   Incidence and Intensity of Adverse Events   [ Time Frame: From the first drug administration until 28 days after the last drug administration, up to 36 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The Data Monitoring Committee recommended termination of recruitment due to low likelihood of the study meeting its primary objectives.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00806819     History of Changes
Other Study ID Numbers: 1199.14, 2008-002072-10
Study First Received: December 10, 2008
Results First Received: November 14, 2014
Last Updated: November 14, 2014
Health Authority: Argentina: Ministry of Health
Australia: Dept of Health and Ageing Therapeutic Goods Admin
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Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Columbia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Ecuador: Public Health Ministry
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Hong Kong: Department of Health
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