Carcinoma, Non-Small-Cell LungNCT01649284

Afatinib Expanded Access Program

A study testing afatinib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 66 sites in United States.

Approved For Marketing

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
What is being tested?: afatinib
Type of treatment: Pill or oral medicine
How many people: Not given
Where: 66 sitesUnited States
Study dates: Jul 2012to Mar 2014
Phase: Expanded access
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with:
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

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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.

Who cannot join

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

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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)

Trial locations and contacts

66 sites in 1 country.

City, postcode or hospital

66 sites in 1 country

United States66 sites

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

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About this study

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)

Conditions: Carcinoma, Non-Small-Cell Lung
Being tested: afatinib
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

afatinibDrug
40, 30, and 20 mg film-coated tablets

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Mar 2014

First posted25 Jul 2012 (estimated)
Study startJul 2012
Primary completionMar 2014
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Expanded access

IDs, dates and publications

ClinicalTrials.gov ID: NCT01649284
Sponsor's protocol ID: 1200.45
Status last verified: Mar 2015
First submitted: 23 Jul 2012
Last updated: 30 Nov 2016
Results posted: No

Publications

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.
PubMed 28680960

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01649284
Acronym / sponsor ID: 1200.45
Conditions: Carcinoma, Non-Small-Cell Lung
Study type: Expanded access
Recruitment status: Approved For Marketing
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 25 Jul 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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:
ECOG score between 0 - 2

Key exclusion criteria (18 listed)

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:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
afatinib40, 30, and 20 mg film-coated tablets	Drug	–

Primary outcome

Not reported in the source record.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
Derived from this study: PubMed 28680960Kim 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

66 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing afatinib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 66 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01649284, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.