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

Status

Indicates the current recruitment status or the expanded access status.
Approved for marketing

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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