search
Back to results

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Adenocarcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pemetrexed
BIBW 2992
Cisplatin
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
  • Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material.
  • Measurable disease according to RECIST 1.1.
  • Eastern Cooperative Oncology Group score of 0 or 1.
  • Age >/= 18 years.
  • Life expectancy of at least three months.
  • Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice guidelines.

Exclusion criteria:

  • Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.
  • Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies.
  • Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.
  • Active brain metastases
  • Any other current malignancy or malignancy diagnosed within the past five years
  • Known pre-existing interstitial lung disease.
  • Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
  • History or presence of clinically relevant cardiovascular abnormalities.
  • Any other concomitant serious illness or organ system dysfunction.
  • Adequate absolute neutrophil count and platelet count
  • Adequate liver and kidney function
  • Active hepatitis B infection, active hepatitis C infection or known HIV carrier.

Sites / Locations

  • Highlands Oncology Group
  • Clinical Trials and Research Associates Inc
  • Innovative Medical Research of South Florida
  • Crescent City Research Consortiom
  • Interlakes Foundation, Incorporated
  • Lehigh Valley Hospital / Lehigh Valley Health Network
  • South Texas Institute of Cancer, Northwest Cancer Center
  • Instituto de Medicina Nuclear de Bahía Blanca
  • Hospital Alemán
  • Imcaba S.R.L.
  • IMAI Research
  • Instituto Alexander Fleming
  • Hospital Militar Central
  • PALIAR
  • Centro Oncológico de Rosario
  • Lifehouse
  • Royal North Shore Hospital
  • Calvary Mater Newcastle Hospital
  • The Prince Charles Hospital
  • Flinders Medical Centre
  • The Burnside War Memorial Hospital
  • Box Hill Hospital
  • St. Vincents Hospital (MEL)
  • Mount Medical Centre
  • KH d. Elisabethinen Linz
  • Klinikum Wels - Grieskirchen GmbH
  • SMZ Baumgartner Hoehe Otto Wagner Spital
  • Brussels - UNIV St-Pierre
  • UNIV UZ Gent
  • Brussels - UNIV UZ Brussel
  • UZ Leuven
  • Centre Hospitalier Universitaire de Liège
  • Centro de Pesquisa do Hospital Lifecenter
  • Centro de Pesquisas Clínicas em Oncología
  • Insituto de Oncologia do Paraná
  • Hospital São Lucas da Pontifícia Universidade Católica
  • UNIFESP Departamento de Medicina de Pneumologia
  • Tom Baker Cancer Centre
  • Cross Cancer Institute (University of Alberta)
  • Charles LeMoyne Hospital
  • Hematologiste et oncologue medical CHUM - Hopital Notre-Dame
  • McGill University, Department of Oncology
  • Hospital Dirección de Previsión de Carabineros
  • Instituto Oncológico Limitada Viña del Mar
  • Instituto Clínico Oncológico del Sur - ICOS
  • HOP d'Angers
  • HOP Côte de Nacre
  • HOP Nord Michallon
  • HOP Croix Rousse, Pneumo, Lyon
  • INS Curie
  • CTR René Gauducheau
  • HOP Sud-Réunion, Pneumo, Saint Pierre
  • HOP - HIA Sainte Anne
  • HOP, Pneumo, Villefranche sur Saône
  • Universitätsklinikum Benjamin Franklin, Berlin
  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
  • Medizinische Hochschule Hannover
  • Lungenklinik Hemer
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Universitätsklinikum Münster
  • Pius-Hospital, Oldenburg
  • National Taiwan University Hospital
  • Queen Mary Hospital
  • Prince of Wales Hospital
  • Szent György Hospital, Szekesfehervar
  • Markusovszky County Hospital, Szombathely
  • Zala County Hospital, Zalaegerszeg
  • St James's Hospital
  • Ospedale San Donato di Arezzo
  • Az. USL 4 di Prato
  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
  • Osp. Silvestrin
  • National Hospital Organization Nagoya Medical Center
  • Aichi Cancer Center Hospital
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • National Hospital Organization Kyushu Cancer Center
  • Hokkaido University Hospital
  • Institute of Biomedical Research and Innovation Hospital
  • Kanazawa University Hospital
  • Kanagawa Cardiovascular and Respiratory Center
  • Niigata Cancer Center Hospital
  • Kurashiki Central Hospital
  • Okayama University Hospital
  • Kindai University Hospital
  • Osaka City Hospital Organization Osaka City General Hospital
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Shizuoka Cancer Center
  • Chungbuk National University Hospital
  • Chonnam National University Hwasun Hospital
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Ulsan University Hospital
  • Hospital Pulau Pinang
  • Pusat Perubatan University Kebangsaan Malaysia
  • University Malaya Medical Centre
  • Hospital Nacional Guillermo Almenara Irigoyen
  • Clínica Anglo Americana
  • Instituto Nacional de Enfermedades Neoplásicas
  • Perpetual Succour Hospital (Cebu)
  • Makati Medical Center
  • St. Luke Medical Centre
  • Institutul Oncologic "Prof. Dr. Ion Chiricuta"
  • ONCOLAB SRL, Craiova
  • Republic Clinical Oncology Dispensary, Dept. Chemotherapy
  • FSBSI "N.N Blokhin Medical Research Center of Oncology"
  • Medical Radiology Science Centre
  • First Pavlov State Medical University Saint Petersburg
  • SPb SBIH "City Clinical Oncological Dispensary"
  • FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Chang Gung Memorial Hospital Kaohsiung
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • NCKUH
  • Taipe Veterans General Hospital
  • Tri-Service General Hospital
  • Chang Gung Memorial Hospital(TaoYuan)
  • Ramathibodi Hospital
  • Maharaj Nakorn Chiang Mai Hospital
  • Srinagarind Hospital
  • Songklanagarind Hospital
  • City Clinical Hospital #4, Dnipropetrovsk State Medical Academy
  • Donetsk Regional Antitumor Centre
  • Kharkiv Regional Clinical Oncology Center
  • Lviv State Oncological Regional Treatment & Diagnostic CTR
  • Royal Devon and Exeter Hospital
  • Royal Surrey County Hospital
  • The Royal Marsden Hospital
  • Maidstone Hospital, Kent Oncology Centre
  • Scunthorpe General Hospital, Oncology
  • The Royal Marsden Hospital
  • Royal Cornwall Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BIBW 2992

Cisplatin/Pemetrexed

Arm Description

BIBW 2992 tablet once daily until progression

Cisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) Time
PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.

Secondary Outcome Measures

Percentage of Patients With Objective Response (OR)
OR was defined as Complete Response (CR) or Partial Response (PR). Assessed by central independent review according to RECIST 1.1.
Percentage of Participants With Disease Control (DC)
DC was defined as a patient with OR or Stable Disease (SD). Assessed by central independent review according to the RECIST 1.1.
Overall Survival (OS) Time
OS was defined as time from randomisation to death.
Tumour Shrinkage
Tumour shrinkage was calculated as the minimum Sum of Diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values were presented after adjusting for baseline SoD, EGFR mutation group and race.
Change From Baseline in Body Weight
Because the PFS was longer for patients in the Afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the Afatinib arm.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work. Ambulatory (>50 percent of waking hours), capable of all self-care, unable to carry out any work activities. Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours. Completely disabled, cannot carry on any self-care, totally confined to bed or chair. Dead.
Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing
HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancer specific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
HRQOL: Time to Deterioration in Dyspnoea
HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
HRQOL: Time to Deterioration in Pain
HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for pain is based on composite of QLQ-C30 questions 9 and 19. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
Trough Plasma Concentrations of Afatinib at Day 22
Trough plasma concentrations of Afatinib at Day 22 (course 2, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.
Trough Plasma Concentrations of Afatinib at Day 29
Trough plasma concentrations of Afatinib at day 29 (course 2, visit 2) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.
Trough Plasma Concentrations of Afatinib at Day 43
Trough plasma concentrations of Afatinib at Day 43 (course 3, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.

Full Information

First Posted
July 29, 2009
Last Updated
March 9, 2018
Sponsor
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT00949650
Brief Title
BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
Official Title
A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 14, 2009 (Actual)
Primary Completion Date
February 9, 2012 (Actual)
Study Completion Date
March 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
345 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIBW 2992
Arm Type
Experimental
Arm Description
BIBW 2992 tablet once daily until progression
Arm Title
Cisplatin/Pemetrexed
Arm Type
Active Comparator
Arm Description
Cisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed IV given once every 3 weeks for up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
BIBW 2992
Intervention Description
BIBW 2992 once daily until progression
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin IV given once every 3 weeks for up to 6 cycles
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) Time
Description
PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.
Time Frame
Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
Secondary Outcome Measure Information:
Title
Percentage of Patients With Objective Response (OR)
Description
OR was defined as Complete Response (CR) or Partial Response (PR). Assessed by central independent review according to RECIST 1.1.
Time Frame
Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
Title
Percentage of Participants With Disease Control (DC)
Description
DC was defined as a patient with OR or Stable Disease (SD). Assessed by central independent review according to the RECIST 1.1.
Time Frame
Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
Title
Overall Survival (OS) Time
Description
OS was defined as time from randomisation to death.
Time Frame
From randomisation to cut-off date (17MAR2017).
Title
Tumour Shrinkage
Description
Tumour shrinkage was calculated as the minimum Sum of Diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values were presented after adjusting for baseline SoD, EGFR mutation group and race.
Time Frame
Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
Title
Change From Baseline in Body Weight
Description
Because the PFS was longer for patients in the Afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the Afatinib arm.
Time Frame
Baseline and throughout the trial until progression (every 3 weeks), up to 28 months.
Title
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Description
ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work. Ambulatory (>50 percent of waking hours), capable of all self-care, unable to carry out any work activities. Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours. Completely disabled, cannot carry on any self-care, totally confined to bed or chair. Dead.
Time Frame
Throughout the trial until progression (every 3 weeks), up to 28 months.
Title
Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing
Description
HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancer specific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
Time Frame
Throughout the trial until progression (every 3 weeks).
Title
HRQOL: Time to Deterioration in Dyspnoea
Description
HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
Time Frame
Throughout the trial until progression (every 3 weeks).
Title
HRQOL: Time to Deterioration in Pain
Description
HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for pain is based on composite of QLQ-C30 questions 9 and 19. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
Time Frame
Throughout the trial until progression (every 3 weeks).
Title
Trough Plasma Concentrations of Afatinib at Day 22
Description
Trough plasma concentrations of Afatinib at Day 22 (course 2, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.
Time Frame
Day 22.
Title
Trough Plasma Concentrations of Afatinib at Day 29
Description
Trough plasma concentrations of Afatinib at day 29 (course 2, visit 2) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.
Time Frame
Day 29.
Title
Trough Plasma Concentrations of Afatinib at Day 43
Description
Trough plasma concentrations of Afatinib at Day 43 (course 3, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.
Time Frame
Day 43.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology. Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material. Measurable disease according to RECIST 1.1. Eastern Cooperative Oncology Group score of 0 or 1. Age >/= 18 years. Life expectancy of at least three months. Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice guidelines. Exclusion criteria: Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation. Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies. Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation. Active brain metastases Any other current malignancy or malignancy diagnosed within the past five years Known pre-existing interstitial lung disease. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom. History or presence of clinically relevant cardiovascular abnormalities. Any other concomitant serious illness or organ system dysfunction. Adequate absolute neutrophil count and platelet count Adequate liver and kidney function Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
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
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Clinical Trials and Research Associates Inc
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Innovative Medical Research of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Facility Name
Crescent City Research Consortiom
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Interlakes Foundation, Incorporated
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Lehigh Valley Hospital / Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
South Texas Institute of Cancer, Northwest Cancer Center
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78410
Country
United States
Facility Name
Instituto de Medicina Nuclear de Bahía Blanca
City
Bahía Blanca
ZIP/Postal Code
B8000FJI
Country
Argentina
Facility Name
Hospital Alemán
City
Capital Federal
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Imcaba S.R.L.
City
Capital Federal
ZIP/Postal Code
C1185AAT
Country
Argentina
Facility Name
IMAI Research
City
Capital Federal
ZIP/Postal Code
C1425AWC
Country
Argentina
Facility Name
Instituto Alexander Fleming
City
Capital Federal
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Hospital Militar Central
City
Capital Federal
ZIP/Postal Code
C1426BOR
Country
Argentina
Facility Name
PALIAR
City
Capital Federal
ZIP/Postal Code
C1430ERF
Country
Argentina
Facility Name
Centro Oncológico de Rosario
City
Rosario
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Calvary Mater Newcastle Hospital
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
The Burnside War Memorial Hospital
City
Toorak Gardens
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
St. Vincents Hospital (MEL)
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Mount Medical Centre
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
KH d. Elisabethinen Linz
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Klinikum Wels - Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
SMZ Baumgartner Hoehe Otto Wagner Spital
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Brussels - UNIV St-Pierre
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UNIV UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Brussels - UNIV UZ Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Centro de Pesquisa do Hospital Lifecenter
City
Belo Horizonte
Country
Brazil
Facility Name
Centro de Pesquisas Clínicas em Oncología
City
Cachoeiro de Itapemirim
ZIP/Postal Code
29308-014
Country
Brazil
Facility Name
Insituto de Oncologia do Paraná
City
Curitiba
ZIP/Postal Code
80530-010
Country
Brazil
Facility Name
Hospital São Lucas da Pontifícia Universidade Católica
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
UNIFESP Departamento de Medicina de Pneumologia
City
Sao Paulo
ZIP/Postal Code
04023-900
Country
Brazil
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute (University of Alberta)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Charles LeMoyne Hospital
City
Greenfield Park
State/Province
Migration Data
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Hematologiste et oncologue medical CHUM - Hopital Notre-Dame
City
Montreal
State/Province
Migration Data
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
McGill University, Department of Oncology
City
Montreal
State/Province
Migration Data
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Hospital Dirección de Previsión de Carabineros
City
Los Condes
ZIP/Postal Code
760-0746
Country
Chile
Facility Name
Instituto Oncológico Limitada Viña del Mar
City
Reñaca
ZIP/Postal Code
2540364
Country
Chile
Facility Name
Instituto Clínico Oncológico del Sur - ICOS
City
Temuco
Country
Chile
Facility Name
HOP d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
HOP Côte de Nacre
City
Caen Cedex 5
ZIP/Postal Code
14033
Country
France
Facility Name
HOP Nord Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
HOP Croix Rousse, Pneumo, Lyon
City
Lyon Cedex 4
ZIP/Postal Code
69317
Country
France
Facility Name
INS Curie
City
Paris Cedex 05
ZIP/Postal Code
75248
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
Saint Pierre - La Réunion
ZIP/Postal Code
97448
Country
France
Facility Name
HOP - HIA Sainte Anne
City
Toulon
ZIP/Postal Code
83041
Country
France
Facility Name
HOP, Pneumo, Villefranche sur Saône
City
Villefranche Sur Saône
ZIP/Postal Code
69655
Country
France
Facility Name
Universitätsklinikum Benjamin Franklin, Berlin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Lungenklinik Hemer
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Pius-Hospital, Oldenburg
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Germany
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Facility Name
Szent György Hospital, Szekesfehervar
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Markusovszky County Hospital, Szombathely
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Zala County Hospital, Zalaegerszeg
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
St James's Hospital
City
Dublin 8
Country
Ireland
Facility Name
Ospedale San Donato di Arezzo
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Az. USL 4 di Prato
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Osp. Silvestrin
City
Sant'Andrea Delle Fratte (PG)
ZIP/Postal Code
06132
Country
Italy
Facility Name
National Hospital Organization Nagoya Medical Center
City
Aichi, Nagoya
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Aichi Cancer Center Hospital
City
Aichi, Nagoya
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Chiba, Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Ehime, Matsuyama
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka, Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Hokkaido University Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Institute of Biomedical Research and Innovation Hospital
City
Hyogo, Kobe
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kanazawa University Hospital
City
Ishikawa, Kanazawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Kanagawa, Yokohama
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata, Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Okayama, Kurashiki
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama, Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka, Osaka-Sayama
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka City Hospital Organization Osaka City General Hospital
City
Osaka, Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Sakai, Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Shizuoka, Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Chungbuk National University Hospital
City
Cheongju
ZIP/Postal Code
361-771
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
682-714
Country
Korea, Republic of
Facility Name
Hospital Pulau Pinang
City
Palau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Pusat Perubatan University Kebangsaan Malaysia
City
Wilayah Persekutuan
ZIP/Postal Code
5600
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Wilayah Persekutuan
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Nacional Guillermo Almenara Irigoyen
City
La Victoria
Country
Peru
Facility Name
Clínica Anglo Americana
City
San Isidro
ZIP/Postal Code
27
Country
Peru
Facility Name
Instituto Nacional de Enfermedades Neoplásicas
City
Surquillo
ZIP/Postal Code
34
Country
Peru
Facility Name
Perpetual Succour Hospital (Cebu)
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Makati Medical Center
City
Makati City
ZIP/Postal Code
1229
Country
Philippines
Facility Name
St. Luke Medical Centre
City
Quezon
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Institutul Oncologic "Prof. Dr. Ion Chiricuta"
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
ONCOLAB SRL, Craiova
City
Craiova
ZIP/Postal Code
200535
Country
Romania
Facility Name
Republic Clinical Oncology Dispensary, Dept. Chemotherapy
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
FSBSI "N.N Blokhin Medical Research Center of Oncology"
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Medical Radiology Science Centre
City
Obninsk
ZIP/Postal Code
249020
Country
Russian Federation
Facility Name
First Pavlov State Medical University Saint Petersburg
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
SPb SBIH "City Clinical Oncological Dispensary"
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital Kaohsiung
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
NCKUH
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Taipe Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital(TaoYuan)
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khonkaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Songklanagarind Hospital
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
City Clinical Hospital #4, Dnipropetrovsk State Medical Academy
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Donetsk Regional Antitumor Centre
City
Donetsk
ZIP/Postal Code
83000
Country
Ukraine
Facility Name
Kharkiv Regional Clinical Oncology Center
City
Kharkiv
ZIP/Postal Code
16070
Country
Ukraine
Facility Name
Lviv State Oncological Regional Treatment & Diagnostic CTR
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
The Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Maidstone Hospital, Kent Oncology Centre
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Scunthorpe General Hospital, Oncology
City
Scunthorpe
ZIP/Postal Code
DN15 7BH
Country
United Kingdom
Facility Name
The Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LJ
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
27601237
Citation
Yang JC, Sequist LV, Zhou C, Schuler M, Geater SL, Mok T, Hu CP, Yamamoto N, Feng J, O'Byrne K, Lu S, Hirsh V, Huang Y, Sebastian M, Okamoto I, Dickgreber N, Shah R, Marten A, Massey D, Wind S, Wu YL. Effect of dose adjustment on the safety and efficacy of afatinib for EGFR mutation-positive lung adenocarcinoma: post hoc analyses of the randomized LUX-Lung 3 and 6 trials. Ann Oncol. 2016 Nov;27(11):2103-2110. doi: 10.1093/annonc/mdw322. Epub 2016 Sep 6.
Results Reference
derived
PubMed Identifier
26823294
Citation
Schuler M, Wu YL, Hirsh V, O'Byrne K, Yamamoto N, Mok T, Popat S, Sequist LV, Massey D, Zazulina V, Yang JC. First-Line Afatinib versus Chemotherapy in Patients with Non-Small Cell Lung Cancer and Common Epidermal Growth Factor Receptor Gene Mutations and Brain Metastases. J Thorac Oncol. 2016 Mar;11(3):380-90. doi: 10.1016/j.jtho.2015.11.014. Epub 2016 Jan 25.
Results Reference
derived
PubMed Identifier
26094656
Citation
Kato T, Yoshioka H, Okamoto I, Yokoyama A, Hida T, Seto T, Kiura K, Massey D, Seki Y, Yamamoto N. Afatinib versus cisplatin plus pemetrexed in Japanese patients with advanced non-small cell lung cancer harboring activating EGFR mutations: Subgroup analysis of LUX-Lung 3. Cancer Sci. 2015 Sep;106(9):1202-11. doi: 10.1111/cas.12723. Epub 2015 Jul 25.
Results Reference
derived
PubMed Identifier
26051236
Citation
Yang JC, Sequist LV, Geater SL, Tsai CM, Mok TS, Schuler M, Yamamoto N, Yu CJ, Ou SH, Zhou C, Massey D, Zazulina V, Wu YL. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015 Jul;16(7):830-8. doi: 10.1016/S1470-2045(15)00026-1. Epub 2015 Jun 4.
Results Reference
derived
PubMed Identifier
25589191
Citation
Yang JC, Wu YL, Schuler M, Sebastian M, Popat S, Yamamoto N, Zhou C, Hu CP, O'Byrne K, Feng J, Lu S, Huang Y, Geater SL, Lee KY, Tsai CM, Gorbunova V, Hirsh V, Bennouna J, Orlov S, Mok T, Boyer M, Su WC, Lee KH, Kato T, Massey D, Shahidi M, Zazulina V, Sequist LV. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015 Feb;16(2):141-51. doi: 10.1016/S1470-2045(14)71173-8. Epub 2015 Jan 12.
Results Reference
derived
PubMed Identifier
23816967
Citation
Yang JC, Hirsh V, Schuler M, Yamamoto N, O'Byrne KJ, Mok TS, Zazulina V, Shahidi M, Lungershausen J, Massey D, Palmer M, Sequist LV. Symptom control and quality of life in LUX-Lung 3: a phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3342-50. doi: 10.1200/JCO.2012.46.1764. Epub 2013 Jul 1.
Results Reference
derived
PubMed Identifier
23816960
Citation
Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3327-34. doi: 10.1200/JCO.2012.44.2806. Epub 2013 Jul 1.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info

Learn more about this trial

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

We'll reach out to this number within 24 hrs