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LUX-Lung 5: Afatinib (BIBW 2992) Plus Weekly Paclitaxel Versus Investigator's Choice of Single Agent Chemotherapy Following Afatinib Monotherapy in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01085136
First received: March 10, 2010
Last updated: October 1, 2014
Last verified: October 2014
Results First Received: October 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Interventions: Drug: Investigator´s choice of chemotherapy
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
Afatinib Monotherapy Test product for Part A: Afatinib film-coated tablet dose: 50 mg/day, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme) mode of admin.: Oral
Afatinib Plus Paclitaxel

Test product for Part B: Afatinib film-coated tablet dose: 40 mg/day, with dose reductions to 30 mg/day and 20 mg/day (following the protocol-defined dose reduction scheme) mode of admin.: Oral

Concomitant therapy for Part B:Paclitaxel dose: 80 mg/m2 once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol-defined dose reduction scheme and the current local summary of product characteristics) mode of admin.: Intravenous

Investigators Choice of Chemotherapy Reference therapy for Part B:Investigators choice of chemotherapy dose: Depending on schedule (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics) mode of admin.: Intravenous or oral, depending on schedule

Participant Flow for 2 periods

Period 1:   Part A
    Afatinib Monotherapy     Afatinib Plus Paclitaxel     Investigators Choice of Chemotherapy  
STARTED     1154     0 [1]   0  
COMPLETED     832 [2]   0     0  
NOT COMPLETED     322     0     0  
Adverse Event                 222                 0                 0  
Protocol Violation                 3                 0                 0  
Lost to Follow-up                 3                 0                 0  
Refusal to continue trial medication                 64                 0                 0  
Other reason not given                 30                 0                 0  
[1] Only Afatinib monotherapy administered in Part A
[2] On-going, progressive disease, clinical progression and discontinued Part A -randomized to Part B

Period 2:   Part B
    Afatinib Monotherapy     Afatinib Plus Paclitaxel     Investigators Choice of Chemotherapy  
STARTED     0 [1]   134     68  
COMPLETED     0     86 [2]   42 [2]
NOT COMPLETED     0     48     26  
Adverse Event                 0                 27                 8  
Refusal to continue trial medication                 0                 12                 7  
Other reason not given                 0                 7                 3  
Not treated                 0                 2                 8  
[1] Afatinib monotherapy not administered in Part B
[2] Completed trial as per protocol, had progressive disease, clinical signs or symptoms of progression



  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, i.e. all patients who were documented to have taken at least 1 dose of afatinib 50 mg in Part A of the trial and all patients who received at least 1 dose of trial medication in Part B.

Reporting Groups
  Description
Part A: Afatinib Monotherapy Test product for Part A: Afatinib film-coated tablet dose: 50 mg/day, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme) mode of admin.: Oral

Baseline Measures
    Part A: Afatinib Monotherapy  
Number of Participants  
[units: participants]
  1154  
Age  
[units: years]
Mean ± Standard Deviation
  60.1  ± 10.9  
Gender  
[units: participants]
 
Female     654  
Male     500  



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS) Time as Determined by RECIST 1.1 for Part B.   [ Time Frame: Every 8 weeks until the final follow-up visit in Part B, up to a total of 10 years. ]

2.  Secondary:   Progression Free Survival (PFS) as Determined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for Part A   [ Time Frame: tumour assessment was at screening (-28 days to screening) and every 6 weeks until the first follow-up visit in Part A, up to a total of 10 years. ]

3.  Secondary:   Overall Survival (OS) as Determined by the Time From Randomization to Death in Part B   [ Time Frame: from the date of randomisation to the date of death, up to a total of 10 years. ]

4.  Secondary:   Objective Response Rate According to RECIST 1.1 in Part B   [ Time Frame: tumour assessment was every 8 weeks until the final follow-up visit in Part B, up to a total of 10 years. ]

5.  Secondary:   Objective Response According to RECIST 1.1 in Part A   [ Time Frame: tumour assessment was at screening (-28 days to screening) and every 6 weeks until the first follow-up visit in Part A, up to a total of 10 years. ]


  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 Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01085136     History of Changes
Other Study ID Numbers: 1200.42, 2009-014563-39
Study First Received: March 10, 2010
Results First Received: October 1, 2014
Last Updated: October 1, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Brazil: National Health Surveillance Agency
China: Food and Drug Administration
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ethics Committee
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: Central Committee Research Involving Human Subjects
Peru: Ministry of Health
Poland: Registration Medicinal Product Medical Device Biocidal Product
Russia: Pharmacological Committee, Ministry of Health
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Taiwan: Department of Health
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration