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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:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01523587
First received: January 30, 2012
Last updated: November 20, 2014
Last verified: November 2014
Results First Received: October 6, 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: 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  
Number of Participants  
[units: participants]
  335     334     669  
Age  
[units: years]
Mean ± Standard Deviation
  64.9  ± 8.30     63.4  ± 8.78     64.1  ± 8.57  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     158     174     332  
>=65 years     177     160     337  
Gender  
[units: participants]
     
Female     50     53     103  
Male     285     281     566  



  Outcome Measures
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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:   03/2016   Safety Issue:   No


  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


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01523587     History of Changes
Other Study ID Numbers: 1200.125, 2011-002380-24
Study First Received: January 30, 2012
Results First Received: October 6, 2014
Last Updated: November 20, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Austria: Medicines and Medical Devices Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Denmark: The Danish Health and Medicines Authority
France: Agence Nationale sécurité médicament et des produits santé
Germany: Paul-Ehrlich-Institute
Greece: Ethics Committee
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Italy: Ethics Committee
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: Central Committee Research Involving Human Subjects
Portugal: National Pharmacy and Medicines Institute
Singapore: Health Sciences Authority
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Taiwan : Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration