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LUX-Lung 5: Afatinib 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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085136
First Posted: March 11, 2010
Last Update Posted: April 4, 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 1, 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: 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
PD = Progression Disease

Reporting Groups
  Description
Afatinib Monotherapy (Part A) Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
Afatinib Plus Paclitaxel (Part B) Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion 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).
Investigators Choice of Chemotherapy (Part B) Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).

Participant Flow for 2 periods

Period 1:   Part A
    Afatinib Monotherapy (Part A)   Afatinib Plus Paclitaxel (Part B)   Investigators Choice of Chemotherapy (Part B)
STARTED   1154   0 [1]   0 
Randomized to Part B   206 [2]   0   0 
COMPLETED   831 [3]   0   0 
NOT COMPLETED   323   0   0 
Other Adverse event                223                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 defined above                30                0                0 
[1] Only Afatinib monotherapy administered in Part A
[2] Discontinued Part A -Randomized to Part B
[3] Randomized to Part B & completed trial as per protocol, had PD, clinical progression.

Period 2:   Part B
    Afatinib Monotherapy (Part A)   Afatinib Plus Paclitaxel (Part B)   Investigators Choice of Chemotherapy (Part B)
STARTED   0 [1]   138   68 
COMPLETED   0 [1]   87 [2]   42 [2] 
NOT COMPLETED   0   51   26 
Other AE                0                29                8 
Refusal to continue trial medication                0                12                7 
Not treated                0                4                8 
Other reason not defined above                0                6                3 
[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
Afatinib Monotherapy (Part A) Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).

Baseline Measures
   Afatinib Monotherapy (Part A) 
Overall Participants Analyzed 
[Units: Participants]
 1154 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      741  64.2% 
>=65 years      413  35.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.1  (10.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      654  56.7% 
Male      500  43.3% 
Race/Ethnicity, Customized 
[Units: Participants]
 
Eastern Asian   491 
Caucasian   459 
Other   29 
Unknown   175 
Baseline Eastern Cooperative Oncology Group (ECOG) performance score [1] 
[Units: Participants]
 
 341 
 691 
 122 
[1] Subjects were graded based on following ECOG PS grade criteria: Grade 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of a light nature. Grade 2: Ambulatory & capable of all selfcare but unable to carry out any work activities. Up & about more than 50% of waking hours. Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours. Grade 4: Completely disabled. Totally confined to bed or chair. Grade 5: Dead.
Smoking history 
[Units: Participants]
 
Never smoked   615 
<15 pack years & stopped >1 year before diagnosis   132 
Other current or ex−smoker   407 
Histologic classification 
[Units: Participants]
 
Adenocarcinoma   985 
Squamous   90 
Other   78 
Missing   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival (Part B)   [ Time Frame: From randomization until disease progression or death; Up to 32 months ]

2.  Secondary:   Progression Free Survival (Part A)   [ Time Frame: From first dose administration until disease progression or death; Up to 51 months ]

3.  Secondary:   Overall Survival (Part B)   [ Time Frame: From randomization until death; Up to 32 months ]

4.  Secondary:   Objective Response (Part A)   [ Time Frame: Post baseline tumour-imaging was performed at every 6 weeks thereafter until disease progression; upto 51 months ]

5.  Secondary:   Objective Response (Part B)   [ Time Frame: Post baseline tumour-imaging was performed at every 8 weeks thereafter until disease progression; up to 32 Months ]

6.  Secondary:   Intensity and Incidence of Adverse Events (AEs) for Part A & Part B.   [ Time Frame: From first administration of treatment until 28 days after last drug administration, up to 51 Months (Part A) and from randomization until 28 days after last drug administration of Trial medication, up to 32 Months (Part B) ]


  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
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  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01085136     History of Changes
Other Study ID Numbers: 1200.42
2009-014563-39 ( EudraCT Number: EudraCT )
First Submitted: March 10, 2010
First Posted: March 11, 2010
Results First Submitted: October 1, 2014
Results First Posted: October 3, 2014
Last Update Posted: April 4, 2017