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Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00806819
First received: December 10, 2008
Last updated: December 8, 2016
Last verified: December 2016
Results First Received: November 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Interventions: Drug: Nintedanib (BIBF1120)
Drug: Pemetrexed
Drug: pemetrexed
Drug: B12
Drug: dexamethasone (or corticosteroid equivalent)
Drug: placebo
Drug: Folic Acid

  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
5 patients at one investigator site were excluded from the enrollment count because of site non-compliance.

Reporting Groups
  Description
Nintedanib Plus Pemetrexed Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Placebo Plus Pemetrexed Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.

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 DBL 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 on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Placebo Plus Pemetrexed Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
Total Total of all reporting groups

Baseline Measures
   Nintedanib Plus Pemetrexed   Placebo Plus Pemetrexed   Total 
Overall Participants Analyzed 
[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]
Count of Participants
     
Female      158  44.8%      152  42.2%      310  43.5% 
Male      195  55.2%      208  57.8%      403  56.5% 


  Outcome Measures
  Show All Outcome Measures

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 data cut-off (15 February 2013), Up to 30 months ]

3.  Secondary:   Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review   [ Time Frame: From randomisation until data cut-off (15 February 2013), Up to 30 months ]

4.  Secondary:   Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator   [ Time Frame: From randomisation until data cut-off (15 February 2013), Up to 30 months ]

5.  Secondary:   Objective Tumor Response   [ Time Frame: From randomisation until data cut-off (15 February 2013), Up to 30 months ]

6.  Secondary:   Duration of Confirmed Objective Tumour Response   [ Time Frame: From randomisation until data cut-off (15 February 2013), Up to 30 months ]

7.  Secondary:   Time to Confirmed Objective Tumour Response   [ Time Frame: From randomisation until data cut-off (15 February 2013), Up to 30 months ]

8.  Secondary:   Disease Control   [ Time Frame: From randomisation until data cut-off (15 February 2013), Up to 30 months ]

9.  Secondary:   Duration of Disease Control   [ Time Frame: From randomisation until data cut-off (15 February 2013), Up to 30 months ]

10.  Secondary:   Change From Baseline in Tumour Size   [ Time Frame: From randomisation until data cut-off (15 February 2013), Up to 30 months ]

11.  Secondary:   Clinical Improvement.   [ Time Frame: From randomisation until data cut-off (15 February 2013), Up to 30 months ]

12.  Secondary:   Quality of Life (QoL)   [ Time Frame: From randomisation until data cut-off (15 February 2013), Up to 30 months ]

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
Recruitment for the study was stopped early based on the results of a pre defined futility analysis.


  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



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00806819     History of Changes
Other Study ID Numbers: 1199.14
2008-002072-10 ( EudraCT Number: EudraCT )
Study First Received: December 10, 2008
Results First Received: November 14, 2014
Last Updated: December 8, 2016