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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/NCT01853826
Registration number
NCT01853826
Ethics application status
Date submitted
13/05/2013
Date registered
15/05/2013
Date last updated
26/03/2024
Titles & IDs
Public title
An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
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Scientific title
An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
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Secondary ID [1]
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2009-017661-34
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Secondary ID [2]
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1200.55
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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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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 - afatinib
Experimental: afatinib - Patients will receive afatinib once daily
Treatment: Drugs: afatinib
Patients will receive afatinib once daily
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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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Adverse Events according to Common Terminology Criteria (CTCAE Version 3)
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Assessment method [1]
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Timepoint [1]
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up to 24 months
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Eligibility
Key inclusion criteria
Inclusion criteria:
Patients with:
- locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
- Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution's
testing methodology.
- Adequate organ function, defined as all of the following:
1. Absolute Neutrophil Count (ANC) > 1500/mm3. (ANC >1000/mm3 may be considered in
special circumstances such as benign cyclical neutropenia as judged by the
investigator and in discussion with the sponsor).
2. Platelet count >75,000/mm3
3. Serum creatinine < 1.5 times of the upper limit of normal
4. Total Bilirubin < 1.5 times upper limit of (institutional) normal (Patients with
Gilbert's syndrome total bilirubin must be <4 times institutional upper limit of
normal).
5. Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) < three
times the upper limit of (institutional) normal (ULN) (if related to liver
metastases < five times ULN).
- Eastern Cooperative Oncology Group (ECOG) score between 0 - 2
- written informed consent by patient or guardian prior to admission into the trial that
is consistent with International Conference on Harmonisation (ICH)- Good Clinical
Practice (GCP) guidelines and local law.
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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:
Patients who or with:
- prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
- anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use
of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer
permitted)
- radiotherapy within 14 days prior to drug administration, except as follows:
1. Palliative radiation to organs other than chest may be allowed up to 2 weeks
prior to drug administration, and
2. Single dose palliative treatment for symptomatic metastasis outside above
allowance to be discussed with sponsor prior to enrolling.
- 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.
- known pre-existing interstitial lung disease
- meningeal carcinomatosis and symptomatic brain metastases (patients with asymptomatic
brain metastases, who were previously treated, are eligible provided they have had
Stable Disease (SD) for at least 4 weeks on stable doses of medication)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Single group
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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
17/07/2013
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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
6/03/2024
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Sample size
Target
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Accrual to date
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Final
481
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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The Prince of Wales Hospital - Randwick
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Sunshine Hospital - AT Albans
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St John of God Murdoch - Murdoch
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2031 - Randwick
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3021 - AT Albans
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Recruitment postcode(s) [3]
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6150 - Murdoch
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Austria
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Graz
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Austria
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Linz
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Zaragoza
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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
To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally
advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have
never been treated with an EGFR-TKI
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01853826
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Trial related presentations / publications
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Contacts
Principal investigator
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Boehringer Ingelheim
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Boehringer Ingelheim
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01853826
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