Afatinib Expanded Access Program

Carcinoma, Non-Small-Cell Lung Clinical Trial

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)

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT01649284
• Other study ID #: 1200.45
• Status: Approved for marketing
• Phase: N/A
• First received: July 23, 2012
• Last updated: November 29, 2016
• Start date: July 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

N/A

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• afatinib
40, 30, and 20 mg film-coated tablets

Locations

Country	Name	City	State
United States	1200.45.105 Boehringer Ingelheim Investigational Site	Albuquerque	New Mexico
United States	1200.45.095 Boehringer Ingelheim Investigational Site	Alpharetta	Georgia
United States	1200.45.078 Boehringer Ingelheim Investigational Site	Anaheim	California
United States	1200.45.053 Boehringer Ingelheim Investigational Site	Ann Arbor	Michigan
United States	1200.45.029 Boehringer Ingelheim Investigational Site	Athens	Georgia
United States	1200.45.071 Boehringer Ingelheim Investigational Site	Billings	Montana
United States	1200.45.086 Boehringer Ingelheim Investigational Site	Bismarck	North Dakota
United States	1200.45.080 Boehringer Ingelheim Investigational Site	Brooklyn	New York
United States	1200.45.114 Boehringer Ingelheim Investigational Site	Burbank	California
United States	1200.45.090 Boehringer Ingelheim Investigational Site	Canton	Ohio
United States	1200.45.093 Boehringer Ingelheim Investigational Site	Charleston	West Virginia
United States	1200.45.001 Boehringer Ingelheim Investigational Site	Charlotte	North Carolina
United States	1200.45.019 Boehringer Ingelheim Investigational Site	Columbia	Maryland
United States	1200.45.005 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	1200.45.049 Boehringer Ingelheim Investigational Site	Cookeville	Tennessee
United States	1200.45.024 Boehringer Ingelheim Investigational Site	Decatur	Illinois
United States	1200.45.046 Boehringer Ingelheim Investigational Site	Detroit	Michigan
United States	1200.45.113 Boehringer Ingelheim Investigational Site	El Paso	Texas
United States	1200.45.009 Boehringer Ingelheim Investigational Site	Evanston	Illinois
United States	1200.45.045 Boehringer Ingelheim Investigational Site	Fairfax	Virginia
United States	1200.45.066 Boehringer Ingelheim Investigational Site	Freehold	New Jersey
United States	1200.45.068 Boehringer Ingelheim Investigational Site	Fresh Meadows	New York
United States	1200.45.123 Boehringer Ingelheim Investigational Site	Glendale	California
United States	1200.45.116 Boehringer Ingelheim Investigational Site	Goodyear	Arizona
United States	1200.45.020 Boehringer Ingelheim Investigational Site	Hershey	Pennsylvania
United States	1200.45.026 Boehringer Ingelheim Investigational Site	Hollywood	Florida
United States	1200.45.097 Boehringer Ingelheim Investigational Site	Hollywood	Florida
United States	1200.45.057 Boehringer Ingelheim Investigational Site	Hot Springs	Arkansas
United States	1200.45.100 Boehringer Ingelheim Investigational Site	Jackson	Mississippi
United States	1200.45.017 Boehringer Ingelheim Investigational Site	Jacksonville	Florida
United States	1200.45.058 Boehringer Ingelheim Investigational Site	Jacksonville	Florida
United States	1200.45.096 Boehringer Ingelheim Investigational Site	Johnstown	Pennsylvania
United States	1200.45.016 Boehringer Ingelheim Investigational Site	Lakeland	Florida
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	1200.45.042 Boehringer Ingelheim Investigational Site	Macon	Georgia
United States	1200.45.083 Boehringer Ingelheim Investigational Site	Marrero	Louisiana
United States	1200.45.087 Boehringer Ingelheim Investigational Site	Metairie	Louisiana
United States	1200.45.103 Boehringer Ingelheim Investigational Site	Miami Beach	Florida
United States	1200.45.048 Boehringer Ingelheim Investigational Site	Minot	North Dakota
United States	1200.45.004 Boehringer Ingelheim Investigational Site	Mobile	Alabama
United States	1200.45.102 Boehringer Ingelheim Investigational Site	Monterey	California
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	1200.45.021 Boehringer Ingelheim Investigational Site	Omaha	Nebraska
United States	1200.45.037 Boehringer Ingelheim Investigational Site	Orlando	Florida
United States	1200.45.099 Boehringer Ingelheim Investigational Site	Peoria	Illinois
United States	1200.45.060 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania
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	1200.45.056 Boehringer Ingelheim Investigational Site	Port St. Lucie	Florida
United States	1200.45.094 Boehringer Ingelheim Investigational Site	Portland	Oregon
United States	1200.45.085 Boehringer Ingelheim Investigational Site	Pottstown	Pennsylvania
United States	1200.45.006 Boehringer Ingelheim Investigational Site	Ranco Cucamonga	California
United States	1200.45.120 Boehringer Ingelheim Investigational Site	Rapid City	South Dakota
United States	1200.45.039 Boehringer Ingelheim Investigational Site	Rockville	Maryland
United States	1200.45.076 Boehringer Ingelheim Investigational Site	Seattle	Washington
United States	1200.45.003 Boehringer Ingelheim Investigational Site	Southington	Connecticut
United States	1200.45.067 Boehringer Ingelheim Investigational Site	St. Louis	Missouri
United States	1200.45.007 Boehringer Ingelheim Investigational Site	Stamford	Connecticut
United States	1200.45.119 Boehringer Ingelheim Investigational Site	Titusville	Florida
United States	1200.45.089 Boehringer Ingelheim Investigational Site	Tulsa	Oklahoma
United States	1200.45.121 Boehringer Ingelheim Investigational Site	Valdosta	Georgia
United States	1200.45.040 Boehringer Ingelheim Investigational Site	Waterloo	Iowa
United States	1200.45.125 Boehringer Ingelheim Investigational Site	Wausau	Wisconsin
United States	1200.45.041 Boehringer Ingelheim Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States,