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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00949650
Registration number
NCT00949650
Ethics application status
Date submitted
29/07/2009
Date registered
30/07/2009
Date last updated
6/04/2018
Titles & IDs
Public title
BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
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Scientific 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
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Secondary ID [1]
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2008-005615-18
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Secondary ID [2]
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1200.32
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung
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Adenocarcinoma
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pemetrexed
Treatment: Drugs - BIBW 2992
Treatment: Drugs - Cisplatin
Experimental: BIBW 2992 - BIBW 2992 tablet once daily until progression
Active Comparator: Cisplatin/Pemetrexed - Cisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles
Treatment: Drugs: Pemetrexed
Pemetrexed IV given once every 3 weeks for up to 6 cycles
Treatment: Drugs: BIBW 2992
BIBW 2992 once daily until progression
Treatment: Drugs: Cisplatin
Cisplatin IV given once every 3 weeks for up to 6 cycles
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS) Time
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Assessment method [1]
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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.
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Timepoint [1]
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Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
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Secondary outcome [1]
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Percentage of Patients With Objective Response (OR)
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Assessment method [1]
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OR was defined as Complete Response (CR) or Partial Response (PR). Assessed by central independent review according to RECIST 1.1.
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Timepoint [1]
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Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
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Secondary outcome [2]
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Percentage of Participants With Disease Control (DC)
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Assessment method [2]
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DC was defined as a patient with OR or Stable Disease (SD). Assessed by central independent review according to the RECIST 1.1.
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Timepoint [2]
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Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
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Secondary outcome [3]
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Overall Survival (OS) Time
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Assessment method [3]
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OS was defined as time from randomisation to death.
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Timepoint [3]
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From randomisation to cut-off date (17MAR2017).
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Secondary outcome [4]
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Tumour Shrinkage
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Assessment method [4]
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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.
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Timepoint [4]
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Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
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Secondary outcome [5]
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Change From Baseline in Body Weight
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and throughout the trial until progression (every 3 weeks), up to 28 months.
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Secondary outcome [6]
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Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
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Assessment method [6]
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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.
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Timepoint [6]
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Throughout the trial until progression (every 3 weeks), up to 28 months.
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Secondary outcome [7]
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Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing
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Assessment method [7]
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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.
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Timepoint [7]
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Throughout the trial until progression (every 3 weeks).
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Secondary outcome [8]
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HRQOL: Time to Deterioration in Dyspnoea
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Assessment method [8]
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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.
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Timepoint [8]
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Throughout the trial until progression (every 3 weeks).
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Secondary outcome [9]
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HRQOL: Time to Deterioration in Pain
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Assessment method [9]
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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.
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Timepoint [9]
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Throughout the trial until progression (every 3 weeks).
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Secondary outcome [10]
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Trough Plasma Concentrations of Afatinib at Day 22
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Assessment method [10]
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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.
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Timepoint [10]
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Day 22.
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Secondary outcome [11]
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Trough Plasma Concentrations of Afatinib at Day 29
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Assessment method [11]
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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.
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Timepoint [11]
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Day 29.
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Secondary outcome [12]
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Trough Plasma Concentrations of Afatinib at Day 43
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Assessment method [12]
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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.
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Timepoint [12]
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Day 43.
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Eligibility
Key inclusion 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/08/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/03/2017
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Sample size
Target
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Accrual to date
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Final
345
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Lifehouse - Camperdown
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Recruitment hospital [2]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [3]
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Calvary Mater Newcastle Hospital - Waratah
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Recruitment hospital [4]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [5]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [6]
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The Burnside War Memorial Hospital - Toorak Gardens
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Recruitment hospital [7]
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Box Hill Hospital - Box Hill
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Recruitment hospital [8]
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St. Vincents Hospital (MEL) - Fitzroy
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Recruitment hospital [9]
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Mount Medical Centre - Perth
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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2298 - Waratah
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Recruitment postcode(s) [4]
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4032 - Chermside
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Recruitment postcode(s) [5]
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5042 - Bedford Park
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Recruitment postcode(s) [6]
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5065 - Toorak Gardens
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Recruitment postcode(s) [7]
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3128 - Box Hill
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Recruitment postcode(s) [8]
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3065 - Fitzroy
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Recruitment postcode(s) [9]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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United States of America
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State/province [2]
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California
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United States of America
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State/province [3]
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Florida
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United States of America
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State/province [4]
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Louisiana
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United States of America
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State/province [5]
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New York
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United States of America
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State/province [6]
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Pennsylvania
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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Argentina
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State/province [8]
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Bahía Blanca
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Country [9]
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Argentina
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State/province [9]
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Capital Federal
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Country [10]
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Argentina
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State/province [10]
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Rosario
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Country [11]
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Austria
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State/province [11]
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Linz
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Country [12]
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Austria
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State/province [12]
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Wels
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Country [13]
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Austria
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State/province [13]
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Wien
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Country [14]
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Belgium
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State/province [14]
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Bruxelles
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Belgium
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Gent
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Belgium
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Jette
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Belgium
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Leuven
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Belgium
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State/province [18]
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Liège
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Brazil
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State/province [19]
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Belo Horizonte
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Brazil
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State/province [20]
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Cachoeiro de Itapemirim
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Brazil
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State/province [21]
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Curitiba
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Brazil
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Porto Alegre
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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Migration Data
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Chile
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Los Condes
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Chile
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Reñaca
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Chile
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Temuco
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France
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Angers
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France
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Caen Cedex 5
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France
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La Tronche
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France
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State/province [32]
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Lyon Cedex 4
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France
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State/province [33]
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Paris Cedex 05
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France
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State/province [34]
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Saint Herblain
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France
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State/province [35]
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Saint Pierre - La Réunion
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France
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Toulon
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France
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State/province [37]
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Villefranche Sur Saône
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Germany
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Berlin
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Germany
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Essen
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Germany
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Hannover
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Germany
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Hemer
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Germany
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Mainz
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Germany
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Münster
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Germany
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Oldenburg
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Germany
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Taipei
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin
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Hungary
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Szekesfehervar
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Hungary
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Szombathely
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Hungary
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Zalaegerszeg
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Ireland
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Dublin 8
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Italy
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Arezzo
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Italy
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Prato
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Italy
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Roma
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Italy
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Sant'Andrea Delle Fratte (PG)
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Japan
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Aichi, Nagoya
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Japan
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Chiba, Kashiwa
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Japan
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Ehime, Matsuyama
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Japan
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Fukuoka, Fukuoka
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Japan
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Hokkaido, Sapporo
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Japan
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Hyogo, Kobe
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Japan
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Ishikawa, Kanazawa
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Japan
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Kanagawa, Yokohama
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Japan
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Niigata, Niigata
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Japan
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Okayama, Kurashiki
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Japan
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Okayama, Okayama
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Japan
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Osaka, Osaka-Sayama
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Japan
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Osaka, Osaka
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Japan
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Sakai, Osaka
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Japan
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Shizuoka, Sunto-gun
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Korea, Republic of
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Cheongju
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Korea, Republic of
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Hwasun
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Korea, Republic of
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Ulsan
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Malaysia
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Palau Pinang
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Malaysia
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Wilayah Persekutuan
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Peru
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La Victoria
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Peru
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San Isidro
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Peru
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Surquillo
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Philippines
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Philippines
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Makati City
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Philippines
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Quezon
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Romania
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Cluj Napoca
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Romania
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Craiova
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Obninsk
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Russian Federation
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St. Petersburg
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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State/province [93]
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Taipei
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Country [94]
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Taiwan
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State/province [94]
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Taoyuan
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Country [95]
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Thailand
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State/province [95]
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Bangkok
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Country [96]
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Thailand
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State/province [96]
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Chiang Mai
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Thailand
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State/province [97]
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Khonkaen
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Thailand
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State/province [98]
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Songkla
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Country [99]
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Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Ukraine
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Lviv
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Country [103]
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United Kingdom
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State/province [103]
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Exeter
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Country [104]
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United Kingdom
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Guildford
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United Kingdom
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London
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United Kingdom
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State/province [106]
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Maidstone
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Country [107]
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United Kingdom
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State/province [107]
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Scunthorpe
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United Kingdom
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Sutton
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United Kingdom
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Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00949650
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Public notes
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Contacts
Principal investigator
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Boehringer Ingelheim
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Boehringer Ingelheim
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00949650
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