Clinical trial NCT01649284: Afatinib Expanded Access Program
Official title: 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 type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-07-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: 1200.45.004 Boehringer Ingelheim Investigational Site
state: Alabama
city: Goodyear
country: United States
facility: 1200.45.116 Boehringer Ingelheim Investigational Site
state: Arizona
city: Hot Springs
country: United States
facility: 1200.45.057 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: 1200.45.078 Boehringer Ingelheim Investigational Site
state: California
city: Burbank
country: United States
facility: 1200.45.114 Boehringer Ingelheim Investigational Site
state: California
city: Glendale
country: United States
facility: 1200.45.123 Boehringer Ingelheim Investigational Site
state: California
city: Lakewood
country: United States
facility: 1200.45.115 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 1200.45.117 Boehringer Ingelheim Investigational Site
state: California
city: Monterey
country: United States
facility: 1200.45.102 Boehringer Ingelheim Investigational Site
state: California
city: Pleasant Hill
country: United States
facility: 1200.45.091 Boehringer Ingelheim Investigational Site
state: California
city: Pleasant Hill
country: United States
facility: 1200.45.098 Boehringer Ingelheim Investigational Site
state: California
city: Ranco Cucamonga
country: United States
facility: 1200.45.006 Boehringer Ingelheim Investigational Site
state: California
city: Southington
country: United States
facility: 1200.45.003 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Stamford
country: United States
facility: 1200.45.007 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Hollywood
country: United States
facility: 1200.45.026 Boehringer Ingelheim Investigational Site
state: Florida
city: Hollywood
country: United States
facility: 1200.45.097 Boehringer Ingelheim Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: 1200.45.017 Boehringer Ingelheim Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: 1200.45.058 Boehringer Ingelheim Investigational Site
state: Florida
city: Lakeland
country: United States
facility: 1200.45.016 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: 1200.45.103 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 1200.45.037 Boehringer Ingelheim Investigational Site
state: Florida
city: Port St. Lucie
country: United States
facility: 1200.45.056 Boehringer Ingelheim Investigational Site
state: Florida
city: Titusville
country: United States
facility: 1200.45.119 Boehringer Ingelheim Investigational Site
state: Florida
city: Alpharetta
country: United States
facility: 1200.45.095 Boehringer Ingelheim Investigational Site
state: Georgia
city: Athens
country: United States
facility: 1200.45.029 Boehringer Ingelheim Investigational Site
state: Georgia
city: Macon
country: United States
facility: 1200.45.042 Boehringer Ingelheim Investigational Site
state: Georgia
city: Valdosta
country: United States
facility: 1200.45.121 Boehringer Ingelheim Investigational Site
state: Georgia
city: Decatur
country: United States
facility: 1200.45.024 Boehringer Ingelheim Investigational Site
state: Illinois
city: Evanston
country: United States
facility: 1200.45.009 Boehringer Ingelheim Investigational Site
state: Illinois
city: Peoria
country: United States
facility: 1200.45.099 Boehringer Ingelheim Investigational Site
state: Illinois
city: Waterloo
country: United States
facility: 1200.45.040 Boehringer Ingelheim Investigational Site
state: Iowa
city: Wichita
country: United States
facility: 1200.45.041 Boehringer Ingelheim Investigational Site
state: Kansas
city: Marrero
country: United States
facility: 1200.45.083 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: 1200.45.087 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Columbia
country: United States
facility: 1200.45.019 Boehringer Ingelheim Investigational Site
state: Maryland
city: Rockville
country: United States
facility: 1200.45.039 Boehringer Ingelheim Investigational Site
state: Maryland
city: Ann Arbor
country: United States
facility: 1200.45.053 Boehringer Ingelheim Investigational Site
state: Michigan
city: Detroit
country: United States
facility: 1200.45.046 Boehringer Ingelheim Investigational Site
state: Michigan
city: Jackson
country: United States
facility: 1200.45.100 Boehringer Ingelheim Investigational Site
state: Mississippi
city: St. Louis
country: United States
facility: 1200.45.067 Boehringer Ingelheim Investigational Site
state: Missouri
city: Billings
country: United States
facility: 1200.45.071 Boehringer Ingelheim Investigational Site
state: Montana
city: Omaha
country: United States
facility: 1200.45.021 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Freehold
country: United States
facility: 1200.45.066 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: 1200.45.105 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Brooklyn
country: United States
facility: 1200.45.080 Boehringer Ingelheim Investigational Site
state: New York
city: Fresh Meadows
country: United States
facility: 1200.45.068 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1200.45.051 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1200.45.092 Boehringer Ingelheim Investigational Site
state: New York
city: Charlotte
country: United States
facility: 1200.45.001 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: 1200.45.086 Boehringer Ingelheim Investigational Site
state: North Dakota
city: Minot
country: United States
facility: 1200.45.048 Boehringer Ingelheim Investigational Site
state: North Dakota
city: Canton
country: United States
facility: 1200.45.090 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 1200.45.005 Boehringer Ingelheim Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: 1200.45.089 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: 1200.45.094 Boehringer Ingelheim Investigational Site
state: Oregon
city: Hershey
country: United States
facility: 1200.45.020 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Johnstown
country: United States
facility: 1200.45.096 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: 1200.45.060 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Pottstown
country: United States
facility: 1200.45.085 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Rapid City
country: United States
facility: 1200.45.120 Boehringer Ingelheim Investigational Site
state: South Dakota
city: Cookeville
country: United States
facility: 1200.45.049 Boehringer Ingelheim Investigational Site
state: Tennessee
city: El Paso
country: United States
facility: 1200.45.113 Boehringer Ingelheim Investigational Site
state: Texas
city: Fairfax
country: United States
facility: 1200.45.045 Boehringer Ingelheim Investigational Site
state: Virginia
city: Seattle
country: United States
facility: 1200.45.076 Boehringer Ingelheim Investigational Site
state: Washington
city: Charleston
country: United States
facility: 1200.45.093 Boehringer Ingelheim Investigational Site
state: West Virginia
city: Wausau
country: United States
facility: 1200.45.125 Boehringer Ingelheim Investigational Site
state: Wisconsin
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Kim ES, Halmos B, Kohut IF, Patel T, Rostorfer RD, Spira AI, Cseh A, McKay J, Wallenstein G, Mileham KF. Efficacy and Safety Results of the Afatinib Expanded Access Program. Oncol Ther. 2017;5(1):103-110. doi: 10.1007/s40487-017-0043-5. Epub 2017 Apr 10.