Afatinib Expanded Access Program

November 29, 2016 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States
        • 1200.45.004 Boehringer Ingelheim Investigational Site
    • Arizona
      • Goodyear, Arizona, United States
        • 1200.45.116 Boehringer Ingelheim Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, United States
        • 1200.45.057 Boehringer Ingelheim Investigational Site
    • California
      • Anaheim, California, United States
        • 1200.45.078 Boehringer Ingelheim Investigational Site
      • Burbank, California, United States
        • 1200.45.114 Boehringer Ingelheim Investigational Site
      • Glendale, California, United States
        • 1200.45.123 Boehringer Ingelheim Investigational Site
      • Lakewood, California, United States
        • 1200.45.115 Boehringer Ingelheim Investigational Site
      • Long Beach, California, United States
        • 1200.45.117 Boehringer Ingelheim Investigational Site
      • Monterey, California, United States
        • 1200.45.102 Boehringer Ingelheim Investigational Site
      • Pleasant Hill, California, United States
        • 1200.45.091 Boehringer Ingelheim Investigational Site
      • Pleasant Hill, California, United States
        • 1200.45.098 Boehringer Ingelheim Investigational Site
      • Ranco Cucamonga, California, United States
        • 1200.45.006 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Southington, Connecticut, United States
        • 1200.45.003 Boehringer Ingelheim Investigational Site
      • Stamford, Connecticut, United States
        • 1200.45.007 Boehringer Ingelheim Investigational Site
    • Florida
      • Hollywood, Florida, United States
        • 1200.45.026 Boehringer Ingelheim Investigational Site
      • Hollywood, Florida, United States
        • 1200.45.097 Boehringer Ingelheim Investigational Site
      • Jacksonville, Florida, United States
        • 1200.45.017 Boehringer Ingelheim Investigational Site
      • Jacksonville, Florida, United States
        • 1200.45.058 Boehringer Ingelheim Investigational Site
      • Lakeland, Florida, United States
        • 1200.45.016 Boehringer Ingelheim Investigational Site
      • Miami Beach, Florida, United States
        • 1200.45.103 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, United States
        • 1200.45.037 Boehringer Ingelheim Investigational Site
      • Port St. Lucie, Florida, United States
        • 1200.45.056 Boehringer Ingelheim Investigational Site
      • Titusville, Florida, United States
        • 1200.45.119 Boehringer Ingelheim Investigational Site
    • Georgia
      • Alpharetta, Georgia, United States
        • 1200.45.095 Boehringer Ingelheim Investigational Site
      • Athens, Georgia, United States
        • 1200.45.029 Boehringer Ingelheim Investigational Site
      • Macon, Georgia, United States
        • 1200.45.042 Boehringer Ingelheim Investigational Site
      • Valdosta, Georgia, United States
        • 1200.45.121 Boehringer Ingelheim Investigational Site
    • Illinois
      • Decatur, Illinois, United States
        • 1200.45.024 Boehringer Ingelheim Investigational Site
      • Evanston, Illinois, United States
        • 1200.45.009 Boehringer Ingelheim Investigational Site
      • Peoria, Illinois, United States
        • 1200.45.099 Boehringer Ingelheim Investigational Site
    • Iowa
      • Waterloo, Iowa, United States
        • 1200.45.040 Boehringer Ingelheim Investigational Site
    • Kansas
      • Wichita, Kansas, United States
        • 1200.45.041 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Marrero, Louisiana, United States
        • 1200.45.083 Boehringer Ingelheim Investigational Site
      • Metairie, Louisiana, United States
        • 1200.45.087 Boehringer Ingelheim Investigational Site
    • Maryland
      • Columbia, Maryland, United States
        • 1200.45.019 Boehringer Ingelheim Investigational Site
      • Rockville, Maryland, United States
        • 1200.45.039 Boehringer Ingelheim Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • 1200.45.053 Boehringer Ingelheim Investigational Site
      • Detroit, Michigan, United States
        • 1200.45.046 Boehringer Ingelheim Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States
        • 1200.45.100 Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, United States
        • 1200.45.067 Boehringer Ingelheim Investigational Site
    • Montana
      • Billings, Montana, United States
        • 1200.45.071 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 1200.45.021 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Freehold, New Jersey, United States
        • 1200.45.066 Boehringer Ingelheim Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • 1200.45.105 Boehringer Ingelheim Investigational Site
    • New York
      • Brooklyn, New York, United States
        • 1200.45.080 Boehringer Ingelheim Investigational Site
      • Fresh Meadows, New York, United States
        • 1200.45.068 Boehringer Ingelheim Investigational Site
      • New York, New York, United States
        • 1200.45.051 Boehringer Ingelheim Investigational Site
      • New York, New York, United States
        • 1200.45.092 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • 1200.45.001 Boehringer Ingelheim Investigational Site
    • North Dakota
      • Bismarck, North Dakota, United States
        • 1200.45.086 Boehringer Ingelheim Investigational Site
      • Minot, North Dakota, United States
        • 1200.45.048 Boehringer Ingelheim Investigational Site
    • Ohio
      • Canton, Ohio, United States
        • 1200.45.090 Boehringer Ingelheim Investigational Site
      • Columbus, Ohio, United States
        • 1200.45.005 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • 1200.45.089 Boehringer Ingelheim Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • 1200.45.094 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • 1200.45.020 Boehringer Ingelheim Investigational Site
      • Johnstown, Pennsylvania, United States
        • 1200.45.096 Boehringer Ingelheim Investigational Site
      • Philadelphia, Pennsylvania, United States
        • 1200.45.060 Boehringer Ingelheim Investigational Site
      • Pottstown, Pennsylvania, United States
        • 1200.45.085 Boehringer Ingelheim Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • 1200.45.120 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Cookeville, Tennessee, United States
        • 1200.45.049 Boehringer Ingelheim Investigational Site
    • Texas
      • El Paso, Texas, United States
        • 1200.45.113 Boehringer Ingelheim Investigational Site
    • Virginia
      • Fairfax, Virginia, United States
        • 1200.45.045 Boehringer Ingelheim Investigational Site
    • Washington
      • Seattle, Washington, United States
        • 1200.45.076 Boehringer Ingelheim Investigational Site
    • West Virginia
      • Charleston, West Virginia, United States
        • 1200.45.093 Boehringer Ingelheim Investigational Site
    • Wisconsin
      • Wausau, Wisconsin, United States
        • 1200.45.125 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (Estimate)

July 25, 2012

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1200.45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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