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LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01466660
First received: November 4, 2011
Last updated: July 7, 2017
Last verified: July 2017
Results First Received: April 4, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lung Neoplasms
Interventions: Drug: Afatinib
Drug: gefitinib

  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
In the study disease response was assessed by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.

Reporting Groups
  Description
Afatinib Afatinib film-coated tablets administered orally, once daily. Starting dose was 40 milligram (mg), dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
Gefitinib Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.

Participant Flow:   Overall Study
    Afatinib   Gefitinib
STARTED   160   159 
COMPLETED   14 [1]   8 [1] 
NOT COMPLETED   146   151 
Progressive Disease (RECIST 1.1)                115                122 
Worsening of underlying cancer disease                5                2 
Other adverse event                18                17 
Protocol Violation                1                1 
Refused continuation of trial medication                4                3 
Other reason not defined above                3                6 
[1] On treatment at analysis cut-off date, 08 April 2016



  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 which included all patients randomised to receive treatment, whether treated or not.

Reporting Groups
  Description
Afatinib Afatinib film-coated tablets administered orally, once daily. Starting dose was 40mg, dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events.
Gefitinib Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events.
Total Total of all reporting groups

Baseline Measures
   Afatinib   Gefitinib   Total 
Overall Participants Analyzed 
[Units: Participants]
 160   159   319 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.7  (11.5)   63.0  (10.4)   62.4  (11.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      91  56.9%      106  66.7%      197  61.8% 
Male      69  43.1%      53  33.3%      122  38.2% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]

2.  Primary:   Time to Treatment Failure (TTF)   [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]

3.  Primary:   Overall Survival   [ Time Frame: From first drug administration until last drug administration, up to 1482 days ]

4.  Secondary:   Objective Response Rate   [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]

5.  Secondary:   Time to Objective Response   [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]

6.  Secondary:   Duration of Objective Response   [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]

7.  Secondary:   Disease Control   [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]

8.  Secondary:   Duration of Disease Control   [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]

9.  Secondary:   Tumour Shrinkage   [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]

10.  Secondary:   Health-related Quality of Life   [ Time Frame: Every 8 weeks, up to 56 weeks ]


  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
No text entered.


  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: NCT01466660     History of Changes
Other Study ID Numbers: 1200.123
2011-001814-33 ( EudraCT Number )
Study First Received: November 4, 2011
Results First Received: April 4, 2017
Last Updated: July 7, 2017