This is an open-label, multi-center, single-arm trial, designed to provide early access to afatinib and to provide additional information on the safety and efficacy of afatinib in 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,
1200.45.116 Boehringer Ingelheim Investigational Site
Goodyear, Arizona,
1200.45.057 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas,
1200.45.078 Boehringer Ingelheim Investigational Site
Anaheim, California,
1200.45.114 Boehringer Ingelheim Investigational Site
Burbank, California,
1200.45.123 Boehringer Ingelheim Investigational Site
Glendale, California,
1200.45.115 Boehringer Ingelheim Investigational Site
Lakewood, California,
1200.45.117 Boehringer Ingelheim Investigational Site
Long Beach, California,
1200.45.102 Boehringer Ingelheim Investigational Site
Monterey, California,
1200.45.091 Boehringer Ingelheim Investigational Site
Pleasant Hill, California,
1200.45.098 Boehringer Ingelheim Investigational Site
Pleasant Hill, California,
1200.45.006 Boehringer Ingelheim Investigational Site
Ranco Cucamonga, California,
1200.45.003 Boehringer Ingelheim Investigational Site
Southington, Connecticut,
1200.45.007 Boehringer Ingelheim Investigational Site
Stamford, Connecticut,
1200.45.026 Boehringer Ingelheim Investigational Site
Hollywood, Florida,
1200.45.097 Boehringer Ingelheim Investigational Site
Hollywood, Florida,
1200.45.017 Boehringer Ingelheim Investigational Site
Jacksonville, Florida,
1200.45.058 Boehringer Ingelheim Investigational Site
Jacksonville, Florida,
1200.45.016 Boehringer Ingelheim Investigational Site
Lakeland, Florida,
1200.45.103 Boehringer Ingelheim Investigational Site
Miami Beach, Florida,
1200.45.037 Boehringer Ingelheim Investigational Site
Orlando, Florida,
1200.45.056 Boehringer Ingelheim Investigational Site
Port St. Lucie, Florida,
1200.45.119 Boehringer Ingelheim Investigational Site
Titusville, Florida,
1200.45.095 Boehringer Ingelheim Investigational Site
Alpharetta, Georgia,
1200.45.029 Boehringer Ingelheim Investigational Site
Athens, Georgia,
1200.45.042 Boehringer Ingelheim Investigational Site
Macon, Georgia,
1200.45.121 Boehringer Ingelheim Investigational Site
Valdosta, Georgia,
1200.45.024 Boehringer Ingelheim Investigational Site
Decatur, Illinois,
1200.45.009 Boehringer Ingelheim Investigational Site
Evanston, Illinois,
1200.45.099 Boehringer Ingelheim Investigational Site
Peoria, Illinois,
1200.45.040 Boehringer Ingelheim Investigational Site
Waterloo, Iowa,
1200.45.041 Boehringer Ingelheim Investigational Site
Wichita, Kansas,
1200.45.083 Boehringer Ingelheim Investigational Site
Marrero, Louisiana,
1200.45.087 Boehringer Ingelheim Investigational Site
Metairie, Louisiana,
1200.45.019 Boehringer Ingelheim Investigational Site
Columbia, Maryland,
1200.45.039 Boehringer Ingelheim Investigational Site
Rockville, Maryland,
1200.45.053 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan,
1200.45.046 Boehringer Ingelheim Investigational Site
Detroit, Michigan,
1200.45.100 Boehringer Ingelheim Investigational Site
Jackson, Mississippi,
1200.45.067 Boehringer Ingelheim Investigational Site
St. Louis, Missouri,
1200.45.071 Boehringer Ingelheim Investigational Site
Billings, Montana,
1200.45.021 Boehringer Ingelheim Investigational Site
Omaha, Nebraska,
1200.45.066 Boehringer Ingelheim Investigational Site
Freehold, New Jersey,
1200.45.105 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico,
1200.45.080 Boehringer Ingelheim Investigational Site
Brooklyn, New York,
1200.45.068 Boehringer Ingelheim Investigational Site
Fresh Meadows, New York,
1200.45.051 Boehringer Ingelheim Investigational Site
New York, New York,
1200.45.092 Boehringer Ingelheim Investigational Site
New York, New York,
1200.45.001 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina,
1200.45.086 Boehringer Ingelheim Investigational Site
Bismarck, North Dakota,
1200.45.048 Boehringer Ingelheim Investigational Site
Minot, North Dakota,
1200.45.090 Boehringer Ingelheim Investigational Site
Canton, Ohio,
1200.45.005 Boehringer Ingelheim Investigational Site
Columbus, Ohio,
1200.45.089 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma,
1200.45.094 Boehringer Ingelheim Investigational Site
Portland, Oregon,
1200.45.020 Boehringer Ingelheim Investigational Site
Hershey, Pennsylvania,
1200.45.096 Boehringer Ingelheim Investigational Site
Johnstown, Pennsylvania,
1200.45.060 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania,
1200.45.085 Boehringer Ingelheim Investigational Site
Pottstown, Pennsylvania,
1200.45.120 Boehringer Ingelheim Investigational Site
Rapid City, South Dakota,
1200.45.049 Boehringer Ingelheim Investigational Site
Cookeville, Tennessee,
1200.45.113 Boehringer Ingelheim Investigational Site
El Paso, Texas,
1200.45.045 Boehringer Ingelheim Investigational Site
Fairfax, Virginia,
1200.45.076 Boehringer Ingelheim Investigational Site
Seattle, Washington,
1200.45.093 Boehringer Ingelheim Investigational Site
Charleston, West Virginia,
1200.45.125 Boehringer Ingelheim Investigational Site
Wausau, Wisconsin,
Boehringer Ingelheim
Study Chair
Boehringer Ingelheim