Back to resultsLUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung
Primary Purpose
Lung Neoplasms
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Afatinib
gefitinib
Sponsored by
About this trial
This is an interventional treatment trial for Lung Neoplasms
Eligibility Criteria
Inclusion criteria:
- Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.
- Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.
- At least one measurable lesion according to response evaluation criteria in solid tumours version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Age >= 18 years.
- 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:
- 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.
- Prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.
- Major surgery within 4 weeks of study randomisation.
- Active brain metastases
- Meningeal carcinomatosis.
- 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.
- Known pre-existing interstitial lung disease.
- Clinically relevant cardiovascular abnormalities as judged by the investigator.
- Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal.
- 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.
- Pregnancy or breast-feeding.
- Active hepatitis and/or known HIV carrier
- Any prohibited concomitant medications for therapy with afatinib or gefitinib
Sites / Locations
- Chris Obrien Lifehouse
- St George Hospital
- The Prince Charles Hospital
- Haematology & Oncology Clinics of Australasia (HOCA)
- Box Hill Hospital
- Austin Health
- Sir Charles Gairdner Hospital
- Cross Cancer Institute (University of Alberta)
- British Columbia Cancer Agency (BCCA) - Fraser Valley Cancer
- BC Cancer Agency - Vancouver
- Lakeridge Health Oshawa
- The Ottawa Hospital
- Montreal General Hospital - McGill University Health Centre
- Cancer Hospital of Chinese Academy of Medical Science
- Beijing Cancer Hospital
- Sun Yat-Sen University Cancer Center
- The Affiliated Cancer Hospital, Guangxi Medical University
- Shanghai Chest Hospital
- Zhongshan Hospital Fudan University
- The First Hospital of Chinese Medical University
- CTR Oncologie du Pays Basque, Onco, Bayonne
- CTR François Baclesse
- HOP Intercommunal
- HOP Michallon
- HOP Dupuytren 1
- CTR Leon Berard
- CTR René Gauducheau
- HOP Sud-Réunion, Pneumo, Saint Pierre
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
- Klinikum Esslingen GmbH
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
- Queen Mary Hospital
- Prince of Wales Hospital
- Beaumont Hospital
- St James's Hospital
- Chungbuk National University Hospital
- Gachon University Gil Medical Center
- Seoul National University Hospital
- Severance Hospital
- Samsung Medical Center
- Asan Medical Center
- Oslo Universitetssykehus HF, Radiumhospitalet
- National Cancer Centre
- Johns Hopkins Singapore International Medical Center
- Hospital Universitario 12 de Octubre
- Hospital Regional Universitario de Málaga
- Hospital Central de Asturias
- Hospital Universitario Marqués de Valdecilla
- Hospital Virgen del Rocío
- Sahlgrenska US, Göteborg
- Universitetssjukhuset, Linköping
- Skånes universitetssjukhus, Lund
- Karolinska Univ. sjukhuset
- Taichung Veterans General Hospital
- NCKUH
- National Taiwan University Hospital
- Taipe Veterans General Hospital
- Chang Gung Memorial Hospital(Linkou)
- Aberdeen Royal Infirmary
- Birmingham City Hospital
- Velindre Cancer Centre
- Western General Hospital
- Royal Surrey County Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
afatinib
gefitinib
Arm Description
afatinib once daily.
gefitinib once daily
Outcomes
Primary Outcome Measures
Progression-free Survival
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.
Time to Treatment Failure (TTF) (Main Overall Survival Analysis Cut-off Date, 08 April 2016)
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
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.
Secondary Outcome Measures
Objective Response Rate
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.
Time to Objective Response
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.
Duration of Objective Response
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.
Disease Control
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.
Duration of Disease Control
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.
Tumour Shrinkage (Main Overall Survival Analysis Cut-off Date, 08 April 2016)
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 (Primary Analysis Cut-off Date, 21 August 2015)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01466660
Brief 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
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 13, 2011 (Actual)
Primary Completion Date
April 8, 2016 (Actual)
Study Completion Date
April 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
319 (Actual)
8. Arms, Groups, and Interventions
Arm Title
afatinib
Arm Type
Experimental
Arm Description
afatinib once daily.
Arm Title
gefitinib
Arm Type
Active Comparator
Arm Description
gefitinib once daily
Intervention Type
Drug
Intervention Name(s)
Afatinib
Other Intervention Name(s)
Giotrif® / Gilotrif®
Intervention Description
afatinib once daily
Intervention Type
Drug
Intervention Name(s)
gefitinib
Intervention Description
Gefitinib once daily
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
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.
Time Frame
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.
Title
Time to Treatment Failure (TTF) (Main Overall Survival Analysis Cut-off Date, 08 April 2016)
Description
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.
Time Frame
From first drug administration until last drug administration, up to 1482 days
Title
Overall Survival
Description
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.
Time Frame
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on death, up to 2465 days.
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
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.
Time Frame
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.
Title
Time to Objective Response
Description
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.
Time Frame
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.
Title
Duration of Objective Response
Description
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.
Time Frame
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.
Title
Disease Control
Description
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.
Time Frame
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.
Title
Duration of Disease Control
Description
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.
Time Frame
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.
Title
Tumour Shrinkage (Main Overall Survival Analysis Cut-off Date, 08 April 2016)
Description
Tumour shrinkage assessed by minimum sum of post-baseline target lesion diameters recorded after randomisation. A positive value shows a decrease in tumour size.
Time Frame
From first drug administration until last drug administration, up to 1482 days
Title
Health-related Quality of Life (Primary Analysis Cut-off Date, 21 August 2015)
Description
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.
Time Frame
Every 8 weeks, up to 56 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.
Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.
At least one measurable lesion according to response evaluation criteria in solid tumours version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Age >= 18 years.
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:
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.
Prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.
Major surgery within 4 weeks of study randomisation.
Active brain metastases
Meningeal carcinomatosis.
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.
Known pre-existing interstitial lung disease.
Clinically relevant cardiovascular abnormalities as judged by the investigator.
Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal.
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.
Pregnancy or breast-feeding.
Active hepatitis and/or known HIV carrier
Any prohibited concomitant medications for therapy with afatinib or gefitinib
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Chris Obrien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Haematology & Oncology Clinics of Australasia (HOCA)
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Cross Cancer Institute (University of Alberta)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency (BCCA) - Fraser Valley Cancer
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V1V 1Z2
Country
Canada
Facility Name
BC Cancer Agency - Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Montreal General Hospital - McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Cancer Hospital of Chinese Academy of Medical Science
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
The Affiliated Cancer Hospital, Guangxi Medical University
City
Nan Ning
ZIP/Postal Code
530021
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
The First Hospital of Chinese Medical University
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
CTR Oncologie du Pays Basque, Onco, Bayonne
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
CTR François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
HOP Intercommunal
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
HOP Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
HOP Dupuytren 1
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
CTR Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
CTR René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
HOP Sud-Réunion, Pneumo, Saint Pierre
City
St-Pierre - La Réunion
ZIP/Postal Code
97448
Country
France
Facility Name
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinikum Esslingen GmbH
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Queen Mary Hospital
City
Hongkong
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Facility Name
Beaumont Hospital
City
Dublin 9
ZIP/Postal Code
D09 Y5R3
Country
Ireland
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Chungbuk National University Hospital
City
Cheongju
ZIP/Postal Code
361-771
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Oslo Universitetssykehus HF, Radiumhospitalet
City
Oslo
ZIP/Postal Code
N-0379
Country
Norway
Facility Name
National Cancer Centre
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Johns Hopkins Singapore International Medical Center
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Regional Universitario de Málaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Sahlgrenska US, Göteborg
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Universitetssjukhuset, Linköping
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Skånes universitetssjukhus, Lund
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Karolinska Univ. sjukhuset
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
NCKUH
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipe Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital(Linkou)
City
Tao-Yuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Birmingham City Hospital
City
Birmingham
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29653820
Citation
Wu YL, Sequist LV, Tan EH, Geater SL, Orlov S, Zhang L, Lee KH, Tsai CM, Kato T, Barrios CH, Schuler M, Hirsh V, Yamamoto N, O'Byrne K, Boyer M, Mok T, Peil B, Marten A, Chih-Hsin Yang J, Paz-Ares L, Park K. Afatinib as First-line Treatment of Older Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Subgroup Analyses of the LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7 Trials. Clin Lung Cancer. 2018 Jul;19(4):e465-e479. doi: 10.1016/j.cllc.2018.03.009. Epub 2018 Mar 17.
Results Reference
derived
PubMed Identifier
28426106
Citation
Paz-Ares L, Tan EH, O'Byrne K, Zhang L, Hirsh V, Boyer M, Yang JC, Mok T, Lee KH, Lu S, Shi Y, Lee DH, Laskin J, Kim DW, Laurie SA, Kolbeck K, Fan J, Dodd N, Marten A, Park K. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial. Ann Oncol. 2017 Feb 1;28(2):270-277. doi: 10.1093/annonc/mdw611.
Results Reference
derived
PubMed Identifier
27083334
Citation
Park K, Tan EH, O'Byrne K, Zhang L, Boyer M, Mok T, Hirsh V, Yang JC, Lee KH, Lu S, Shi Y, Kim SW, Laskin J, Kim DW, Arvis CD, Kolbeck K, Laurie SA, Tsai CM, Shahidi M, Kim M, Massey D, Zazulina V, Paz-Ares L. Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial. Lancet Oncol. 2016 May;17(5):577-89. doi: 10.1016/S1470-2045(16)30033-X. Epub 2016 Apr 12.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
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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
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