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LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00525148
First received: September 3, 2007
Last updated: July 28, 2016
Last verified: July 2016
Results First Received: August 8, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Intervention: Drug: BIBW 2992

  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
First-line Afatinib 40 mg First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 40 mg daily after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
First-line Afatinib 50 mg First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
Second-line Afatinib 40 mg Second-line patients received a starting oral dose of Afatinib 40 mg daily only after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
Second-line Afatinib 50 mg Second-line patients received a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.

Participant Flow:   Overall Study
    First-line Afatinib 40 mg   First-line Afatinib 50 mg   Second-line Afatinib 40 mg   Second-line Afatinib 50 mg
STARTED   23 [1]   38 [1]   7 [1]   61 [1] 
COMPLETED   0   0   0   0 
NOT COMPLETED   23   38   7   61 
Other Adverse Event                3                5                1                8 
Progressive disease                18                30                6                49 
Refused continuation of study medication                0                2                0                1 
Other than stated                2                1                0                3 
[1] entered and treated



  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.
Treated set: The patients who had taken at least one dose of afatinib were included in the treated set.

Reporting Groups
  Description
First-line Afatinib 40 mg First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 40 mg daily after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
First-line Afatinib 50 mg First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
Second-line Afatinib 40 mg Second-line patients received a starting oral dose of Afatinib 40 mg daily only after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
Second-line Afatinib 50 mg Second-line patients received a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
Total Total of all reporting groups

Baseline Measures
   First-line Afatinib 40 mg   First-line Afatinib 50 mg   Second-line Afatinib 40 mg   Second-line Afatinib 50 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   38   7   61   129 
Age 
[Units: Years]
Mean (Standard Deviation)
 64  (11.0)   62  (9.6)   57  (14.5)   61  (11.5)   62  (11.1) 
Gender 
[Units: Number of participants]
         
Female   13   27   3   32   75 
Male   10   11   4   29   54 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response (OR) as Determined by RECIST 1.0   [ Time Frame: Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months. ]

2.  Secondary:   Clinical Benefit as Determined by RECIST 1.0   [ Time Frame: Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months. ]

3.  Secondary:   Duration of Clinical Benefit   [ Time Frame: Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months. ]

4.  Secondary:   Duration of Objective Response   [ Time Frame: Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months. ]

5.  Secondary:   Time to Objective Response   [ Time Frame: Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months. ]

6.  Secondary:   Progression-free Survival   [ Time Frame: Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months. ]

7.  Secondary:   Overall Survival Time   [ Time Frame: Start of treatment to time to all death, up to 93 months ]

8.  Secondary:   Cpre,ss,29   [ Time Frame: -0:05h (pre-dose) on Day 29 ]

9.  Secondary:   Safety of BIBW 2992 as Indicated by Incidence of Specified Adverse Events.   [ Time Frame: First administration of trial medication until 28 days after last administration of trial medication, up to 93 months. ]

10.  Secondary:   Safety of BIBW 2992 as Indicated by Intensity and Incidence of Worst Adverse Events Graded According to NCI CTCAE Version 3.0   [ Time Frame: First administration of trial medication until 28 days after last administration of trial medication, up to 93 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
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  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
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00525148     History of Changes
Other Study ID Numbers: 1200.22
Study First Received: September 3, 2007
Results First Received: August 8, 2013
Last Updated: July 28, 2016
Health Authority: Taiwan: Department of Health, Executive Yuan, Taiwan
United States: Food and Drug Administration