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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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01466660
First Posted: November 8, 2011
Last Update Posted: November 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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.

Condition Intervention Phase
Lung Neoplasms Drug: Afatinib Drug: gefitinib Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Progression-free survival (PFS) defined as the time from the date of randomisation to the date of disease progression, or to date of death if a patient died earlier. Disease progression was primarily evaluated by an independent central imaging review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.

  • Time to Treatment Failure (TTF) [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Time to Treatment Failure (TTF) which was the time from the date of randomisation to the date of i.e. permanent treatment discontinuation for any reason.

  • Overall Survival [ Time Frame: From first drug administration until last drug administration, up to 1482 days ]
    Overall survival (OS) which was defined as the time from the date of randomisation to the date of death.


Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Objective response rate (ORR) which was defined as the number of participants with complete response (CR) or partial response (PR) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. divided by the total number of participants who received treatment. Per RECIST v1.1. for target lesions and assessed by CT-scan or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions from baseline; Overall Response (OR) = CR + PR

  • Time to Objective Response [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]

    Number of participants with objective response over time, cumulative number of participants is displayed.

    Time to objective response was defined as the time from randomisation to the first recorded objective response.


  • Duration of Objective Response [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Duration of objective response defined as the time of first objective response to the time of progression or death, whichever occurred first (or date of censoring for progression free survival (PFS))

  • Disease Control [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Disease control which was defined as objective response (complete response or partial response) or stable disease (SD).

  • Duration of Disease Control [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Duration of disease control was measured from randomisation to the time of progressive disease (PD) or death, whichever occurred first (or date of censoring for progression free survival (PFS))

  • Tumour Shrinkage [ Time Frame: From first drug administration until last drug administration, up to 1293 days ]
    Tumour shrinkage assessed by minimum sum of post-baseline target lesion diameters recorded after randomisation. A positive value shows a decrease in tumour size.

  • Health-related Quality of Life [ Time Frame: Every 8 weeks, up to 56 weeks ]

    Health-related quality of life (HRQoL) measured using European Quality of life - 5 Dimensions (EQ-5D) score for United Kingdom (UK) and Belgium and European European Quality Visual Analogue Scale (EQ-VAS).

    EQ-5D utility scores range from 0 (worst health) to 1 (full health).

    EQ-VAS scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Results display the mean score up to 56 weeks.



Enrollment: 319
Actual Study Start Date: December 13, 2011
Estimated Study Completion Date: May 31, 2018
Primary Completion Date: April 8, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: afatinib
afatinib once daily.
Drug: Afatinib
afatinib once daily
Other Name: Giotrif® / Gilotrif®
Active Comparator: gefitinib
gefitinib once daily
Drug: gefitinib
Gefitinib once daily

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466660


  Hide Study Locations
Locations
Australia, New South Wales
Chris Obrien Lifehouse
Camperdown, New South Wales, Australia, 2050
St George Hospital
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Haematology & Oncology Clinics of Australasia (HOCA)
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Austin Health
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Canada, Alberta
Cross Cancer Institute (University of Alberta)
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency (BCCA) - Fraser Valley Cancer
Surrey, British Columbia, Canada, V1V 1Z2
BC Cancer Agency - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
China
Cancer Hospital of Chinese Academy of Medical Science
Beijing, China, 100021
Beijing Cancer Hospital
Beijing, China, 100036
Sun Yat-Sen University Cancer Center
Guangzhou, China, 510060
The Affiliated Cancer Hospital, Guangxi Medical University
Nan Ning, China, 530021
Shanghai Chest Hospital
Shanghai, China, 200030
Zhongshan Hospital Fudan University
Shanghai, China, 200032
The First Hospital of Chinese Medical University
Shenyang, China, 110001
France
CTR Oncologie du Pays Basque, Onco, Bayonne
Bayonne, France, 64100
CTR F Baclesse
Caen, France, 14076
HOP Intercommunal, Mint, Créteil
Créteil Cedex, France, 94010
HOP Nord Michallon
La Tronche, France, 38700
HOP Dupuytren
Limoges Cedex, France, 87042
CTR Léon Bérard
Lyon, France, 69373
CTR René Gauducheau, Onco, St Herblain
Saint Herblain Cedex, France, 44805
HOP Sud-Réunion, Pneumo, Saint Pierre
St-Pierre - La Réunion, France, 97448
Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Germany, 45122
Klinikum Esslingen GmbH
Esslingen, Germany, 73730
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Hong Kong
Queen Mary Hospital
Hongkong, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Ireland
Beaumont Hospital
Dublin 9, Ireland, D09 Y5R3
St James's Hospital
Dublin, Ireland, 8
Korea, Republic of
Chungbuk National University Hospital
Cheongju, Korea, Republic of, 361-771
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405-760
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Norway
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, Norway, N-0310
Singapore
National Cancer Centre
Singapore, Singapore, 169610
Johns Hopkins Singapore International Medical Center
Singapore, Singapore, 308433
Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Regional Universitario de Málaga
Malaga, Spain, 29010
Hospital Central de Asturias
Oviedo, Spain, 33006
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Hospital Virgen del Rocío
Sevilla, Spain, 41013
Sweden
Sahlgrenska US, Göteborg
Göteborg, Sweden, 413 45
Universitetssjukhuset, Linköping
Linköping, Sweden, 581 85
Skånes universitetssjukhus
Lund, Sweden, 221 85
Karolinska Univ. sjukhuset
Stockholm, Sweden, 171 76
Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan, 407
NCKUH
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 100
Taipe Veterans General Hospital
Taipei, Taiwan, 112
Chang Gung Memorial Hospital(TaoYuan)
Tao-Yuan, Taiwan, 333
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Royal Surrey County Hospital
Guildford, United Kingdom, GU2 7XX
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01466660     History of Changes
Other Study ID Numbers: 1200.123
2011-001814-33 ( EudraCT Number )
First Submitted: November 4, 2011
First Posted: November 8, 2011
Results First Submitted: April 4, 2017
Results First Posted: June 19, 2017
Last Update Posted: November 15, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action