Trial record 1 of 1 for:
Afatinib Expanded Access Program
This treatment has been approved for sale to the public.
Information provided by (Responsible Party):
First received: July 23, 2012
Last updated: November 29, 2016
Last verified: March 2015
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.
Carcinoma, Non-Small-Cell Lung
What is Expanded Access?
||LUX-Lung EAP US; An Open Label Expanded Access Program of Afatinib (BIBW 2992) for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
40, 30, and 20 mg film-coated tablets
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
- Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution's testing methodology.
- male or female patients age >=18 years
Adequate organ function, defined as all of the following:
- Left Ventricular Ejection Fraction (LVEF) >50% or within institution normal values
- Absolute Neutrophil Count (ANC) > 1500/mm3.
- Platelet count >75,000/mm3
- Serum creatinine < 1.5 times of the upper limit of normal
- Total Bilirubin < 1.5 times upper limit of (institutional) normal.
- Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) < three times the upper limit of (institutional) normal (ULN).
- 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:
- 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)
Radiotherapy within 14 days prior to drug administration, except as follows:
- Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
- Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
- major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial
- known hypersensitivity to afatinib or any of its excipients
- 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.
- 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.
- 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
- 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
- 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.
- 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
- known pre-existing interstitial lung disease
- presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug based on treating physician assessment.
- active hepatitis B infection, active Hepatitis C (HEP C) infection and/or known Human Immunodeficiency Virus (HIV) carrier.
- meningeal carcinomatosis
- 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649284
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 23, 2012
||November 29, 2016
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 07, 2016
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases