An Open Label Trial of Afatinib 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)
- 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. Left Ventricular Ejection Fraction (LVEF) >50% or within institution normal
2. 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).
3. Platelet count >75,000/mm3
4. Serum creatinine < 1.5 times of the upper limit of normal
5. 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
6. 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.
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
- 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)