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Trial record 1 of 1 for:    NCT01466660
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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

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.
 
ClinicalTrials.gov Identifier: NCT01466660
Recruitment Status : Completed
First Posted : November 8, 2011
Results First Posted : June 19, 2017
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE November 4, 2011
First Posted Date  ICMJE November 8, 2011
Results First Submitted Date  ICMJE April 4, 2017
Results First Posted Date  ICMJE June 19, 2017
Last Update Posted Date April 30, 2019
Actual Study Start Date  ICMJE December 13, 2011
Actual Primary Completion Date April 8, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
  • Progression-free Survival [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Progression-free survival (PFS) defined as the time from the date of randomisation to the date of disease progression, or to date of death if a patient died earlier. Disease progression was primarily evaluated by an independent central imaging review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
  • Time to Treatment Failure (TTF) [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Time to Treatment Failure (TTF) which was the time from the date of randomisation to the date of i.e. permanent treatment discontinuation for any reason.
  • Overall Survival [ Time Frame: From first drug administration until last drug administration, up to 1482 days ]
    Overall survival (OS) which was defined as the time from the date of randomisation to the date of death.
Original Primary Outcome Measures  ICMJE
 (submitted: November 4, 2011)
  • Progression-free survival (PFS) [ Time Frame: 12 months ]
  • Disease control rate including complete response, partial response and stable disease at 12 months. [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2017)
  • Objective Response Rate [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Objective response rate (ORR) which was defined as the number of participants with complete response (CR) or partial response (PR) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. divided by the total number of participants who received treatment. Per RECIST v1.1. for target lesions and assessed by CT-scan or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions from baseline; Overall Response (OR) = CR + PR
  • Time to Objective Response [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Number of participants with objective response over time, cumulative number of participants is displayed. Time to objective response was defined as the time from randomisation to the first recorded objective response.
  • Duration of Objective Response [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Duration of objective response defined as the time of first objective response to the time of progression or death, whichever occurred first (or date of censoring for progression free survival (PFS))
  • Disease Control [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Disease control which was defined as objective response (complete response or partial response) or stable disease (SD).
  • Duration of Disease Control [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Duration of disease control was measured from randomisation to the time of progressive disease (PD) or death, whichever occurred first (or date of censoring for progression free survival (PFS))
  • Tumour Shrinkage [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Tumour shrinkage assessed by minimum sum of post-baseline target lesion diameters recorded after randomisation. A positive value shows a decrease in tumour size.
  • Health-related Quality of Life [ Time Frame: Every 8 weeks, up to 56 weeks ]
    Health-related quality of life (HRQoL) measured using European Quality of life - 5 Dimensions (EQ-5D) score for United Kingdom (UK) and Belgium and European European Quality Visual Analogue Scale (EQ-VAS). EQ-5D utility scores range from 0 (worst health) to 1 (full health). EQ-VAS scores range from 0 (worst imaginable health state) to 100 (best imaginable health state). Results display the mean score up to 56 weeks.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2011)
  • Overall survival [ Time Frame: 24 months ]
  • Objective response rate by response evaluation criteria in solid tumours version 1.1 [ Time Frame: 24 months ]
  • Disease control rate by response evaluation criteria in solid tumours version 1.1 at 6 and 9 months [ Time Frame: 24 months ]
  • Time to Objective Response [ Time Frame: 24 months ]
  • Duration of Objective Response [ Time Frame: 24 months ]
  • Duration of disease control [ Time Frame: 24 months ]
  • Tumour shrinkage by the maximum percentage reduction from baseline sum of target lesion [ Time Frame: 24 months ]
  • Health-related quality of life measured by EQ-5D-3L [ Time Frame: 24 months ]
  • Time to treatment failure [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE LUX-Lung 7: A Randomised, Open-label Phase IIb Trial of Afatinib Versus Gefitinib as First-line Treatment of Patients With EGFR Mutation Positive Advanced Adenocarcinoma of the Lung
Brief Summary This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Neoplasms
Intervention  ICMJE
  • Drug: Afatinib
    afatinib once daily
    Other Name: Giotrif® / Gilotrif®
  • Drug: gefitinib
    Gefitinib once daily
Study Arms  ICMJE
  • Experimental: afatinib
    afatinib once daily.
    Intervention: Drug: Afatinib
  • Active Comparator: gefitinib
    gefitinib once daily
    Intervention: Drug: gefitinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2015)
319
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2011)
264
Actual Study Completion Date  ICMJE April 12, 2019
Actual Primary Completion Date April 8, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.
  2. Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.
  3. At least one measurable lesion according to response evaluation criteria in solid tumours version 1.1
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  5. Age >= 18 years.
  6. Adequate organ function as defined by the following criteria:

Serum aspartate transaminase(AST) and serum alanine transaminase(ALT) =< 3 x upper limit of normal (ULN), or AST and ALT =<5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin =<1.5 x ULN Absolute neutrophil count (ANC) >=1.5 x 109/L Creatinine clearance > 45ml / min Platelets >= 75 x 109/L

Exclusion criteria:

  1. Prior systemic chemotherapy for stage IIIB or IV non-small cell lung cancer. Neo-/adjuvant chemotherapy, chemoradiation or radiotherapy is permitted if at least 12 months has elapsed prior to disease progression.
  2. Prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.
  3. Major surgery within 4 weeks of study randomisation.
  4. Active brain metastases
  5. Meningeal carcinomatosis.
  6. Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured in the opinion of investigator.
  7. Known pre-existing interstitial lung disease.
  8. Clinically relevant cardiovascular abnormalities as judged by the investigator.
  9. Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal.
  10. Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.
  11. Pregnancy or breast-feeding.
  12. Active hepatitis and/or known HIV carrier
  13. Any prohibited concomitant medications for therapy with afatinib or gefitinib
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   China,   France,   Germany,   Hong Kong,   Ireland,   Korea, Republic of,   Norway,   Singapore,   Spain,   Sweden,   Taiwan,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01466660
Other Study ID Numbers  ICMJE 1200.123
2011-001814-33 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP