This is an open-label, multi-center, single-arm trial, designed to provide early accessto afatinib and to provide additional information on the safety and efficacy of afatinibin advanced NSCLC patients who harbor an EGFR mutation.
Drug: afatinib
40, 30, and 20 mg film-coated tablets
Inclusion criteria:
Patients with:
1. locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
2. Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the
institution's testing methodology.
3. male or female patients age >=18 years
4. Adequate organ function, defined as all of the following:
1. Left Ventricular Ejection Fraction (LVEF) >50% or within institution normal
values
2. Absolute Neutrophil Count (ANC) > 1500/mm3.
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.
6. Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) < three
times the upper limit of (institutional) normal (ULN).
5. ECOG score between 0 - 2
6. 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.
Exclusion criteria:
Patients who or with:
1. hormonal 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)
2. 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.
3. major surgery within 4 weeks before starting trial treatment or scheduled for
surgery during the projected course of the trial
4. known hypersensitivity to afatinib or any of its excipients
5. history or presence of clinically relevant cardiovascular abnormalities such as
uncontrolled hypertension, congestive heart failure New York Heart Association
(NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as
determined by the treating physician. Myocardial infarction within 6 months prior to
starting trial treatment.
6. are 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 trial entry, for
the duration of trial participation and for at least 2 weeks after treatment has
ended.
7. childbearing potential who are: a) are nursing or b) are pregnant or c) are not
using an acceptable method of birth control, or do not plan to continue using this
method throughout the trial and/or do not agree to submit to pregnancy testing
required by this protocol
8. any history of or concomitant condition that, in the opinion of the treating
physician, would compromise the patient's ability to comply with the trial or
interfere with the evaluation of safety for the trial drug
9. 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.
10. requiring treatment with any of the prohibited concomitant medications listed in
Section 4.2.2 of the protocol that can not be stopped for the duration of trial
participation
11. known pre-existing interstitial lung disease
12. presence of poorly controlled gastrointestinal disorders that could affect the
absorption of the trial drug based on treating physician assessment.
13. active hepatitis B infection, active Hepatitis C (HEP C) infection and/or known
Human Immunodeficiency Virus (HIV) carrier.
14. meningeal carcinomatosis
15. 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)
1200.45.004 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
1200.45.116 Boehringer Ingelheim Investigational Site
Goodyear, Arizona, United States
1200.45.057 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas, United States
1200.45.078 Boehringer Ingelheim Investigational Site
Anaheim, California, United States
1200.45.114 Boehringer Ingelheim Investigational Site
Burbank, California, United States
1200.45.123 Boehringer Ingelheim Investigational Site
Glendale, California, United States
1200.45.115 Boehringer Ingelheim Investigational Site
Lakewood, California, United States
1200.45.117 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
1200.45.102 Boehringer Ingelheim Investigational Site
Monterey, California, United States
1200.45.091 Boehringer Ingelheim Investigational Site
Pleasant Hill, California, United States
1200.45.098 Boehringer Ingelheim Investigational Site
Pleasant Hill, California, United States
1200.45.006 Boehringer Ingelheim Investigational Site
Ranco Cucamonga, California, United States
1200.45.003 Boehringer Ingelheim Investigational Site
Southington, Connecticut, United States
1200.45.007 Boehringer Ingelheim Investigational Site
Stamford, Connecticut, United States
1200.45.026 Boehringer Ingelheim Investigational Site
Hollywood, Florida, United States
1200.45.097 Boehringer Ingelheim Investigational Site
Hollywood, Florida, United States
1200.45.017 Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
1200.45.058 Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
1200.45.016 Boehringer Ingelheim Investigational Site
Lakeland, Florida, United States
1200.45.103 Boehringer Ingelheim Investigational Site
Miami Beach, Florida, United States
1200.45.037 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
1200.45.056 Boehringer Ingelheim Investigational Site
Port St. Lucie, Florida, United States
1200.45.119 Boehringer Ingelheim Investigational Site
Titusville, Florida, United States
1200.45.095 Boehringer Ingelheim Investigational Site
Alpharetta, Georgia, United States
1200.45.029 Boehringer Ingelheim Investigational Site
Athens, Georgia, United States
1200.45.042 Boehringer Ingelheim Investigational Site
Macon, Georgia, United States
1200.45.121 Boehringer Ingelheim Investigational Site
Valdosta, Georgia, United States
1200.45.024 Boehringer Ingelheim Investigational Site
Decatur, Illinois, United States
1200.45.009 Boehringer Ingelheim Investigational Site
Evanston, Illinois, United States
1200.45.099 Boehringer Ingelheim Investigational Site
Peoria, Illinois, United States
1200.45.040 Boehringer Ingelheim Investigational Site
Waterloo, Iowa, United States
1200.45.041 Boehringer Ingelheim Investigational Site
Wichita, Kansas, United States
1200.45.083 Boehringer Ingelheim Investigational Site
Marrero, Louisiana, United States
1200.45.087 Boehringer Ingelheim Investigational Site
Metairie, Louisiana, United States
1200.45.019 Boehringer Ingelheim Investigational Site
Columbia, Maryland, United States
1200.45.039 Boehringer Ingelheim Investigational Site
Rockville, Maryland, United States
1200.45.053 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan, United States
1200.45.046 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
1200.45.100 Boehringer Ingelheim Investigational Site
Jackson, Mississippi, United States
1200.45.067 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
1200.45.071 Boehringer Ingelheim Investigational Site
Billings, Montana, United States
1200.45.021 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
1200.45.066 Boehringer Ingelheim Investigational Site
Freehold, New Jersey, United States
1200.45.105 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico, United States
1200.45.080 Boehringer Ingelheim Investigational Site
Brooklyn, New York, United States
1200.45.068 Boehringer Ingelheim Investigational Site
Fresh Meadows, New York, United States
1200.45.051 Boehringer Ingelheim Investigational Site
New York, New York, United States
1200.45.092 Boehringer Ingelheim Investigational Site
New York, New York, United States
1200.45.001 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
1200.45.086 Boehringer Ingelheim Investigational Site
Bismarck, North Dakota, United States
1200.45.048 Boehringer Ingelheim Investigational Site
Minot, North Dakota, United States
1200.45.090 Boehringer Ingelheim Investigational Site
Canton, Ohio, United States
1200.45.005 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
1200.45.089 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma, United States
1200.45.094 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
1200.45.020 Boehringer Ingelheim Investigational Site
Hershey, Pennsylvania, United States
1200.45.096 Boehringer Ingelheim Investigational Site
Johnstown, Pennsylvania, United States
1200.45.060 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1200.45.085 Boehringer Ingelheim Investigational Site
Pottstown, Pennsylvania, United States
1200.45.120 Boehringer Ingelheim Investigational Site
Rapid City, South Dakota, United States
1200.45.049 Boehringer Ingelheim Investigational Site
Cookeville, Tennessee, United States
1200.45.113 Boehringer Ingelheim Investigational Site
El Paso, Texas, United States
1200.45.045 Boehringer Ingelheim Investigational Site
Fairfax, Virginia, United States
1200.45.076 Boehringer Ingelheim Investigational Site
Seattle, Washington, United States
1200.45.093 Boehringer Ingelheim Investigational Site
Charleston, West Virginia, United States
1200.45.125 Boehringer Ingelheim Investigational Site
Wausau, Wisconsin, United States
Boehringer Ingelheim, Study Chair
Boehringer Ingelheim