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LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01523587
First Posted: February 1, 2012
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
Results First Submitted: October 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Interventions: Drug: afatinib
Drug: erlotinib

  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
The number of patients included in this primary analysis of PFS are the number randomised up until the cut off date of 7th October 2013.

Reporting Groups
  Description
Afatinib Once Daily 40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
Erlotinib Once Daily 150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.

Participant Flow:   Overall Study
    Afatinib Once Daily   Erlotinib Once Daily
STARTED   335   334 
COMPLETED   248 [1]   280 [1] 
NOT COMPLETED   87   54 
Adverse Event                52                34 
Non Compliance with protocol                2                1 
Lost to Follow-up                2                2 
Withdrawal by Subject                23                12 
no reason given                2                3 
Randomised but not treated                6                2 
[1] Pts that withdrew due to PD (RECIST 1.1), PD (non RECIST1.1) and ongoing were considered Completed.



  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.
All patients who were randomised, regardless of whether they received investigational treatment, are defined as the Randomised Set.

Reporting Groups
  Description
Afatinib Once Daily 40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
Erlotinib Once Daily 150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
Total Total of all reporting groups

Baseline Measures
   Afatinib Once Daily   Erlotinib Once Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 335   334   669 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      158  47.2%      174  52.1%      332  49.6% 
>=65 years      177  52.8%      160  47.9%      337  50.4% 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.9  (8.30)   63.4  (8.78)   64.1  (8.57) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      50  14.9%      53  15.9%      103  15.4% 
Male      285  85.1%      281  84.1%      566  84.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival, Based on Central Independent Review as Determined by RECIST 1.1   [ Time Frame: First treatment administration up until cut off date of 7th October 2013 (up to 78 weeks). ]

2.  Secondary:   Objective Response According to RECIST 1.1   [ Time Frame: First treatment administration until cut off date of 7th October 2013 (up to 78 weeks). ]

3.  Secondary:   Disease Control According to RECIST 1.1   [ Time Frame: First treatment administration until cut off date of 7th October 2013 (up to 78 weeks). ]

4.  Secondary:   Tumour Shrinkage   [ Time Frame: First treatment administration until cut off date of 7th October 2013 (up to 78 weeks). ]

5.  Secondary:   Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire   [ Time Frame: First treatment administration up to 28 days after the last intake of study medication. ]

6.  Secondary:   Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.   [ Time Frame: First treatment administration up to 28 days after the last intake of study medication. ]

7.  Secondary:   Change in Score Over Time in Coughing,Dyspnoea and Pain   [ Time Frame: First treatment administration up to 28 days after last intake of study medication ]

8.  Secondary:   Overall Survival   [ Time Frame: From randomisation until 632 deaths ]
Results not yet reported.   Anticipated Reporting Date:   08/2017  


  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 Centre
Organization: Boehringer Ingelheim Pharmaceuticals
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: NCT01523587     History of Changes
Other Study ID Numbers: 1200.125
2011-002380-24 ( EudraCT Number: EudraCT )
First Submitted: January 30, 2012
First Posted: February 1, 2012
Results First Submitted: October 6, 2014
Results First Posted: November 21, 2014
Last Update Posted: September 11, 2017