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
- Registration Number
- NCT01466660
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 319
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description afatinib Afatinib afatinib once daily. gefitinib gefitinib gefitinib once daily
- Primary Outcome Measures
Name Time Method Progression-free Survival 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. 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) From first drug administration until last drug administration, up to 1482 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 From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on death, up to 2465 days. 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
Name Time Method Objective Response Rate 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. 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.
Duration of Objective Response 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. 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.
Duration of Disease Control 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. 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.
Health-related Quality of Life (Primary Analysis Cut-off Date, 21 August 2015) 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.Time to Objective Response 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. 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.
Disease Control 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. 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.
Tumour Shrinkage (Main Overall Survival Analysis Cut-off Date, 08 April 2016) From first drug administration until last drug administration, up to 1482 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.
Trial Locations
- Locations (63)
CTR Leon Berard
🇫🇷Lyon, France
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Cancer Hospital of Chinese Academy of Medical Science
🇨🇳Beijing, China
Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
Beijing Cancer Hospital
🇨🇳Beijing, China
BC Cancer Agency - Vancouver
🇨🇦Vancouver, British Columbia, Canada
Sahlgrenska US, Göteborg
🇸🇪Göteborg, Sweden
Skånes universitetssjukhus, Lund
🇸🇪Lund, Sweden
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Zhongshan Hospital Fudan University
🇨🇳Shanghai, China
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Universitetssjukhuset, Linköping
🇸🇪Linköping, Sweden
Karolinska Univ. sjukhuset
🇸🇪Stockholm, Sweden
National Cancer Centre
🇸🇬Singapore, Singapore
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
NCKUH
🇨🇳Tainan, Taiwan
HOP Intercommunal
🇫🇷Créteil, France
Chungbuk National University Hospital
🇰🇷Cheongju, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
St George Hospital
🇦🇺Kogarah, New South Wales, Australia
Cross Cancer Institute (University of Alberta)
🇨🇦Edmonton, Alberta, Canada
Chris Obrien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Lakeridge Health Oshawa
🇨🇦Oshawa, Ontario, Canada
Montreal General Hospital - McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, China
HOP Michallon
🇫🇷La Tronche, France
Shanghai Chest Hospital
🇨🇳Shanghai, China
CTR Oncologie du Pays Basque, Onco, Bayonne
🇫🇷Bayonne, France
The Affiliated Cancer Hospital, Guangxi Medical University
🇨🇳Nan Ning, China
CTR François Baclesse
🇫🇷Caen, France
HOP Dupuytren 1
🇫🇷Limoges Cedex, France
The First Hospital of Chinese Medical University
🇨🇳Shenyang, China
HOP Sud-Réunion, Pneumo, Saint Pierre
🇫🇷St-Pierre - La Réunion, France
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
🇩🇪Essen, Germany
CTR René Gauducheau
🇫🇷Saint Herblain, France
Beaumont Hospital
🇮🇪Dublin 9, Ireland
St James's Hospital
🇮🇪Dublin, Ireland
Klinikum Esslingen GmbH
🇩🇪Esslingen, Germany
Johns Hopkins Singapore International Medical Center
🇸🇬Singapore, Singapore
Oslo Universitetssykehus HF, Radiumhospitalet
🇳🇴Oslo, Norway
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Regional Universitario de Málaga
🇪🇸Malaga, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Velindre Cancer Centre
🇬🇧Cardiff, United Kingdom
Birmingham City Hospital
🇬🇧Birmingham, United Kingdom
Taipe Veterans General Hospital
🇨🇳Taipei, Taiwan
British Columbia Cancer Agency (BCCA) - Fraser Valley Cancer
🇨🇦Surrey, British Columbia, Canada
Chang Gung Memorial Hospital(Linkou)
🇨🇳Tao-Yuan, Taiwan
Haematology & Oncology Clinics of Australasia (HOCA)
🇦🇺South Brisbane, Queensland, Australia
Queen Mary Hospital
🇭🇰Hongkong, Hong Kong
Prince of Wales Hospital
🇭🇰Shatin, Hong Kong