Single-arm Trial of BIBW 2992 (Afatinib) in Demographically and Genotypically Selected NSCLC Patients
A Phase II Single-arm Trial of BIBW 2992 in Demographically and Genotypically Selected NSCLC
2 other identifiers
interventional
41
2 countries
7
Brief Summary
The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria, in patients with advanced NSCLC Stage IIIB or IV whose tumours harbour activating mutations within exon 18 to exon 21 of the EGFR receptor, in patients with mutations in the HER2/neu receptor and in patients with EGFR FISH positive tumours with no EGFR mutations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 30, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedResults Posted
Study results publicly available
October 23, 2013
CompletedMarch 26, 2014
February 1, 2014
3.6 years
June 30, 2008
August 9, 2013
February 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Best Objective Response
Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.
Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.
Secondary Outcomes (3)
Percentage of Participants With Disease Control (DC)
Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.
Progression Free Survival (PFS) Time
Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.
Summary of Pre-dose Concentrations of Afatnib in Plasma
Day 15, 29 and 57
Study Arms (2)
BIBW 2992
EXPERIMENTALpatient to receive tablets of BIBW 2992 once a day, starting at high dose until progression of the disease
BIBW 2992 + paclitaxel
EXPERIMENTALpatient whose disease progressed on treatment with BIBW 2992 monotherapy to receive tablet of BIBW 2992 once a day in combination with i.v. paclitaxel 3 weekly
Interventions
tablet BIBW 2992 in combination with i.v. paclitaxel 3 weekly
Eligibility Criteria
You may qualify if:
- patients with pathologically confirmed diagnosis of NSCLC stage IIIB/IV adeno- or bronchoalveolar carcinoma (BAC)
- non smokers patients or patients having smoked less than 15 pack years and who stopped smoking for at least one year before diagnosis (except for patients with her2-neu mutation)
- presence of activating mutation(s) in exon 18 to exon 21 of the EGFR or HER2-neu-receptor confirmed by direct DNA sequencing of NSCLC tumor tissue or increased copy number of the EGFR gene as determined by FISH analysis
- prior treatment up to 3 lines of chemotherapy except for HER2-neu patients (no restrictions) no prior EGFR TKI therapy for EGFR mutation negative and FISCH positive patients
- patients with at least one tumor lesion that can accurately be measured by CTscan or MRI in at least one dimension with long diameter to be recorded as \> or equal to 20 mm using conventional techniques or \> or equal to 10 mm with spiral CT scan
- male or female patient aged above or equal to 18 years
- life expectancy of at least 3 months
- written informed consents that is consistent with ICH-GCP guidelines
- ECOG performance score 0, 1 or 2
You may not qualify if:
- more than 3 prior cytotoxic chemotherapy treatment regimen for relapsed or metastatic NSCLC, except for patients with HER2-neu mutations who may have received any prior therapy
- Any chemo-, hormone- or immunotherapy within the past 4 weeks or within less than 4 half-lives of the previous drug prior to treatment with the trial drug and/or persistence of toxicities of prior anticancer therapies which are deemed to be clinically relevant
- brain metastases which are symptomatic; patients with treated asymptomatic brain metastases are eligible with stable brain disease for at least 4 weeks without requirement for steroids or anti-epileptic therapy
- significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g. Crohn's disease, malabsorption or CTCAE Grade \> 2 diarrhea of any etiology at baseline
- patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
- other malignancies diagnosed within the past 5 years (other than non melanomatous skin cancer and in situ cervical cancer)
- radiotherapy within the past 2 weeks prior to treatment with the trial drug
- patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents)
- patients with known HIV, active hepatitis B or active hepatitis C
- known or suspected active drug or alcohol abuse
- women of childbearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
- pregnancy or breast feeding
- patient unable to comply with the protocol
- history of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3
- Cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or Echocardiogram.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
1200.41.32003 Boehringer Ingelheim Investigational Site
Antwerp, Belgium
1200.41.32007 Boehringer Ingelheim Investigational Site
Charleroi, Belgium
1200.41.32001 Boehringer Ingelheim Investigational Site
Jette, Belgium
1200.41.32011 Boehringer Ingelheim Investigational Site
Leuven, Belgium
1200.41.32008 Boehringer Ingelheim Investigational Site
Liège, Belgium
1200.41.32006 Boehringer Ingelheim Investigational Site
Namur, Belgium
1200.41.34001 Boehringer Ingelheim Investigational Site
Badalona (Barcelona), Spain
Related Publications (1)
De Greve J, Teugels E, Geers C, Decoster L, Galdermans D, De Mey J, Everaert H, Umelo I, In't Veld P, Schallier D. Clinical activity of afatinib (BIBW 2992) in patients with lung adenocarcinoma with mutations in the kinase domain of HER2/neu. Lung Cancer. 2012 Apr;76(1):123-7. doi: 10.1016/j.lungcan.2012.01.008. Epub 2012 Feb 10.
PMID: 22325357DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2008
First Posted
August 8, 2008
Study Start
June 1, 2008
Primary Completion
January 1, 2012
Last Updated
March 26, 2014
Results First Posted
October 23, 2013
Record last verified: 2014-02