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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00525148
First received: September 3, 2007
Last updated: January 24, 2014
Last verified: January 2014
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 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 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 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 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     4 [2]   9 [2]   1 [2]   6 [2]
NOT COMPLETED     19     29     6     55  
Other Adverse Event                 3                 4                 1                 7  
Progressive disease                 16                 24                 5                 44  
Withdrawal by Subject                 0                 1                 0                 1  
Unknown                 0                 0                 0                 3  
[1] entered and treated
[2] Continuing on treatment at data collection cutoff 06-Apr-2011



  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.
No text entered.

Reporting Groups
  Description
First-line Afatinib 40 mg First-line patients were enrolled after Amendment 1 with a starting 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 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 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 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  
Number of Participants  
[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
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1.  Primary:   Objective Response (OR)   [ Time Frame: Baseline to data cut-off for independent review (12 Jan 2011) ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From first dose of study medication until progression, death, start of another anti-cancer therapy or last date of tumor imaging for ongoing patients. ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: From first dose of study medication to data cut-off ]

4.  Secondary:   Clinical Benefit (CB)   [ Time Frame: From first dose of study medication to data cut-off ]

5.  Secondary:   Duration of OR   [ Time Frame: From first dose of study medication to data cut-off ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


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 by Boehringer Ingelheim

Publications automatically indexed to this study:

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: January 24, 2014
Health Authority: Taiwan: Department of Health, Executive Yuan, Taiwan
United States: Food and Drug Administration