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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01466660
Registration number
NCT01466660
Ethics application status
Date submitted
4/11/2011
Date registered
8/11/2011
Date last updated
7/04/2020
Titles & IDs
Public title
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
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Scientific title
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
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Secondary ID [1]
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2011-001814-33
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Secondary ID [2]
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1200.123
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Neoplasms
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Afatinib
Treatment: Drugs - gefitinib
Experimental: afatinib - afatinib once daily.
Active Comparator: gefitinib - gefitinib once daily
Treatment: Drugs: Afatinib
afatinib once daily
Treatment: Drugs: gefitinib
Gefitinib once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival
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Assessment method [1]
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Progression-free survival (PFS) defined as the time from date of randomisation to date of disease progression, or date of death if a patient died earlier. Participants with no event (Disease progression (PD) or death) were censored. PD was primarily evaluated for the primary analysis by an independent central imaging review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Per RECIST version 1.1. for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): PD, At least a 20% increase in the sum of the longest diameter (SoD) of target lesions taking as reference the smallest SoD of target lesions recorded since the treatment started, together with an absolute increase in the SoD of target lesions of at least 5 millimetre (mm) or the appearance of one or more new lesions. For the final analysis (analysis cut-off date 12 April 2019) status and date of PD were determined by investigator assessment.
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Timepoint [1]
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From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
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Primary outcome [2]
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Time to Treatment Failure (TTF) (Main Overall Survival Analysis Cut-off Date, 08 April 2016)
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Assessment method [2]
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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.
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Timepoint [2]
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From first drug administration until last drug administration, up to 1482 days
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Primary outcome [3]
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Overall Survival
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Assessment method [3]
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Overall survival (OS) which was defined as the time from the date of randomisation to the date of death. Participants for whom there is no evidence of death at the time of the analysis will be censored at the date that they were last known to be alive.
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Timepoint [3]
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From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on death, up to 2465 days.
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Secondary outcome [1]
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Objective Response Rate
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Assessment method [1]
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Objective response rate (ORR) which was defined as the number of participants with best overall response of 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 version 1.1. for target lesions and assessed by Computed Tomography (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. For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment.
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Timepoint [1]
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From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
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Secondary outcome [2]
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Time to Objective Response
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Assessment method [2]
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Number of participants with objective response (best overall response of complete response or partial response) to study treatment 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. For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment.
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Timepoint [2]
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From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
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Secondary outcome [3]
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Duration of Objective Response
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Assessment method [3]
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Duration of objective response defined as the time of first objective response (best overall response of complete response or partial response) to the time of progression or death, whichever occurred first (or date of censoring for progression free survival). For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment.
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Timepoint [3]
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From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
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Secondary outcome [4]
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Disease Control
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Assessment method [4]
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Percentage of participants with disease control which was defined as the number of participants with best overall response of complete response (CR) or partial response (PR) or stable disease (SD) 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 version 1.1. for target lesions and assessed by Computed Tomography (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; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Responses of SD were only considered if they occur =42 days from date of randomisation. For the final analysis (analysis cut-off date 12 April 2019) disease control was determined by investigator assessment.
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Timepoint [4]
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From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
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Secondary outcome [5]
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Duration of Disease Control
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Assessment method [5]
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Duration of disease control defined as the time from randomisation to the time of progression or death, whichever occurred first (or date of censoring for progression free survival). For the final analysis (analysis cut-off date 12 April 2019) the status and date of disease progression were determined by investigator assessment.
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Timepoint [5]
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From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
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Secondary outcome [6]
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Tumour Shrinkage (Main Overall Survival Analysis Cut-off Date, 08 April 2016)
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Assessment method [6]
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Tumour shrinkage assessed by minimum sum of post-baseline target lesion diameters recorded after randomisation. A positive value shows a decrease in tumour size.
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Timepoint [6]
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From first drug administration until last drug administration, up to 1482 days
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Secondary outcome [7]
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Health-related Quality of Life (Primary Analysis Cut-off Date, 21 August 2015)
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Assessment method [7]
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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.
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Timepoint [7]
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Every 8 weeks, up to 56 weeks
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Eligibility
Key inclusion criteria
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
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Minimum age
18
Years
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Maximum age
90
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/12/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/04/2019
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Sample size
Target
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Accrual to date
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Final
319
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Chris Obrien Lifehouse - Camperdown
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Recruitment hospital [2]
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St George Hospital - Kogarah
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Recruitment hospital [3]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [4]
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Haematology & Oncology Clinics of Australasia (HOCA) - South Brisbane
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Recruitment hospital [5]
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Box Hill Hospital - Box Hill
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Recruitment hospital [6]
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Austin Health - Heidelberg
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Recruitment hospital [7]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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4032 - Chermside
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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China
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State/province [5]
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Beijing
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Country [6]
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China
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State/province [6]
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Guangzhou
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Country [7]
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China
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Nan Ning
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China
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Shanghai
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China
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Shenyang
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France
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Bayonne
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France
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Caen
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France
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State/province [12]
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Créteil
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France
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State/province [13]
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La Tronche
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France
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Limoges Cedex
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France
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Lyon
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France
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Saint Herblain
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France
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State/province [17]
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St-Pierre - La Réunion
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Germany
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Essen
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Germany
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Esslingen
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Germany
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Mainz
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Hong Kong
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Hongkong
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Hong Kong
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Shatin
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Ireland
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Dublin 9
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Ireland
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State/province [24]
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Dublin
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Country [25]
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Korea, Republic of
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Cheongju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Norway
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Oslo
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Singapore
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Singapore
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Oviedo
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Spain
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State/province [33]
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Santander
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Country [34]
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Spain
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Sevilla
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Sweden
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Göteborg
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Sweden
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State/province [36]
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Linköping
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Sweden
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Lund
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Sweden
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Stockholm
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Taiwan
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Taichung
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Taiwan
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State/province [40]
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Tainan
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Taiwan
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Taipei
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Taiwan
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Tao-Yuan
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United Kingdom
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Aberdeen
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United Kingdom
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Birmingham
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United Kingdom
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Cardiff
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United Kingdom
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Edinburgh
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United Kingdom
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State/province [47]
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Guildford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01466660
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Boehringer Ingelheim
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Address
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Boehringer Ingelheim
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Email
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Contact person for public queries
Name
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01466660
Download to PDF