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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01466660




Registration number
NCT01466660
Ethics application status
Date submitted
4/11/2011
Date registered
8/11/2011
Date last updated
7/04/2020

Titles & IDs
Public title
LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung
Scientific title
LUX-Lung 7: A Randomised, Open-label Phase IIb Trial of Afatinib Versus Gefitinib as First-line Treatment of Patients With EGFR Mutation Positive Advanced Adenocarcinoma of the Lung
Secondary ID [1] 0 0
2011-001814-33
Secondary ID [2] 0 0
1200.123
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Afatinib
Treatment: Drugs - gefitinib

Experimental: afatinib - afatinib once daily.

Active comparator: gefitinib - gefitinib once daily


Treatment: Drugs: Afatinib
afatinib once daily

Treatment: Drugs: gefitinib
Gefitinib once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
Time to Treatment Failure (TTF) (Main Overall Survival Analysis Cut-off Date, 08 April 2016)
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
From first drug administration until last drug administration, up to 1482 days
Primary outcome [3] 0 0
Overall Survival
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
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 [1] 0 0
Objective Response Rate
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Time to Objective Response
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Duration of Objective Response
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Disease Control
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
Duration of Disease Control
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
Tumour Shrinkage (Main Overall Survival Analysis Cut-off Date, 08 April 2016)
Assessment method [6] 0 0
Tumour shrinkage assessed by minimum sum of post-baseline target lesion diameters recorded after randomisation. A positive value shows a decrease in tumour size.
Timepoint [6] 0 0
From first drug administration until last drug administration, up to 1482 days
Secondary outcome [7] 0 0
Health-related Quality of Life (Primary Analysis Cut-off Date, 21 August 2015)
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
Every 8 weeks, up to 56 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.
2. Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.
3. At least one measurable lesion according to response evaluation criteria in solid tumours version 1.1
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
5. Age >= 18 years.
6. Adequate organ function as defined by the following criteria:

Serum aspartate transaminase(AST) and serum alanine transaminase(ALT) =< 3 x upper limit of normal (ULN), or AST and ALT =<5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin =<1.5 x ULN Absolute neutrophil count (ANC) >=1.5 x 109/L Creatinine clearance > 45ml / min Platelets >= 75 x 109/L
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Prior systemic chemotherapy for stage IIIB or IV non-small cell lung cancer. Neo-/adjuvant chemotherapy, chemoradiation or radiotherapy is permitted if at least 12 months has elapsed prior to disease progression.
2. Prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.
3. Major surgery within 4 weeks of study randomisation.
4. Active brain metastases
5. Meningeal carcinomatosis.
6. Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured in the opinion of investigator.
7. Known pre-existing interstitial lung disease.
8. Clinically relevant cardiovascular abnormalities as judged by the investigator.
9. Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal.
10. Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.
11. Pregnancy or breast-feeding.
12. Active hepatitis and/or known HIV carrier
13. Any prohibited concomitant medications for therapy with afatinib or gefitinib

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/04/2019
Sample size
Target
Accrual to date
Final
319
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Chris Obrien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 0 0
Haematology & Oncology Clinics of Australasia (HOCA) - South Brisbane
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
Austin Health - Heidelberg
Recruitment hospital [7] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Guangzhou
Country [7] 0 0
China
State/province [7] 0 0
Nan Ning
Country [8] 0 0
China
State/province [8] 0 0
Shanghai
Country [9] 0 0
China
State/province [9] 0 0
Shenyang
Country [10] 0 0
France
State/province [10] 0 0
Bayonne
Country [11] 0 0
France
State/province [11] 0 0
Caen
Country [12] 0 0
France
State/province [12] 0 0
Créteil
Country [13] 0 0
France
State/province [13] 0 0
La Tronche
Country [14] 0 0
France
State/province [14] 0 0
Limoges Cedex
Country [15] 0 0
France
State/province [15] 0 0
Lyon
Country [16] 0 0
France
State/province [16] 0 0
Saint Herblain
Country [17] 0 0
France
State/province [17] 0 0
St-Pierre - La Réunion
Country [18] 0 0
Germany
State/province [18] 0 0
Essen
Country [19] 0 0
Germany
State/province [19] 0 0
Esslingen
Country [20] 0 0
Germany
State/province [20] 0 0
Mainz
Country [21] 0 0
Hong Kong
State/province [21] 0 0
Hongkong
Country [22] 0 0
Hong Kong
State/province [22] 0 0
Shatin
Country [23] 0 0
Ireland
State/province [23] 0 0
Dublin 9
Country [24] 0 0
Ireland
State/province [24] 0 0
Dublin
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Cheongju
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Incheon
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul
Country [28] 0 0
Norway
State/province [28] 0 0
Oslo
Country [29] 0 0
Singapore
State/province [29] 0 0
Singapore
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Spain
State/province [31] 0 0
Malaga
Country [32] 0 0
Spain
State/province [32] 0 0
Oviedo
Country [33] 0 0
Spain
State/province [33] 0 0
Santander
Country [34] 0 0
Spain
State/province [34] 0 0
Sevilla
Country [35] 0 0
Sweden
State/province [35] 0 0
Göteborg
Country [36] 0 0
Sweden
State/province [36] 0 0
Linköping
Country [37] 0 0
Sweden
State/province [37] 0 0
Lund
Country [38] 0 0
Sweden
State/province [38] 0 0
Stockholm
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taichung
Country [40] 0 0
Taiwan
State/province [40] 0 0
Tainan
Country [41] 0 0
Taiwan
State/province [41] 0 0
Taipei
Country [42] 0 0
Taiwan
State/province [42] 0 0
Tao-Yuan
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Aberdeen
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Birmingham
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Cardiff
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Edinburgh
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Guildford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01466660