Carcinoma, Non-Small-Cell LungNCT01931306
Expanded Access Study of Afatinib in Treatment-naive or Chemotherapy Pre-treated Patients With Non-small Cell Lung Cancer (NSCLC)
A study testing Afatinib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 8 sites in South Korea.
Trial summary
To provide expanded access and to evaluate the safety, tolerability and efficacy of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring Epidermal Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an EGFR tyrosine kinase inhibitor (TKI) 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
- How many people
- Not given
- Where
- 8 sitesSouth Korea
- Study dates
- Start not givento not given
- 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
- locally advanced or metastatic Non-Small Cell Lung Cancer
- Epidermal Growth Factor Receptor mutation positive result per the institution's testing methodology. Any type of EGFR mutation allowed
- Treatment naïve or patients who have received one line of chemotherapy, chemotherapy include neo adjuvant and adjuvant chemotherapy within 1 year from enrolment
- male or female patients age more than 18 years
- Adequate organ function, defined as all of the following:
- Absolute Neutrophil Count over 1500 per mm3. ANC over 1000 per mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor.
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- Platelet count more than 75,000 per mm3
- Serum creatinine below 1.5 times of the upper limit of normal
- Total Bilirubin below 1.5 times upper limit of institutional normal. Patients with Gilbert's syndrome total bilirubin must be below 4 times institutional upper limit of normal.
- Aspartate Amino Transferase or Alanine Amino Transferase below three times the upper limit of normal, if related to liver metastases below five times 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 - Good Clinical Practice guidelines and local law.
Who cannot join
- prior treatment with an EGFR tyrosine kinase inhibitor
- 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 classification of over 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to starting trial treatment.
- Women of Child-Bearing Potential and men who are able to father a child, unwilling to 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 nursing or
- are pregnant or
- 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 investigator, 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 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
- active hepatitis B infection, active Hepatitis C infection
- meningeal carcinomatosis
- symptomatic brain metastases, patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had Stable Disease for at least 4 weeks on stable doses of medication
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, 14647
Gachon University Gil Medical Center
Incheon, 405-760
Chonnam National University Hwasun Hospital
Jeonnam, 519-763
Gyeongsang National University Hospital
Jinju, 660-702
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, 06591
Severance Hospital
Seoul, 120-752
Samsung Medical Center
Seoul, 135-710
SMG-SNU Boramae Medical Center
Seoul, 156-707
About this study
Official title: An Open Label Expanded Access Program of Afatinib (BIBW 2992) in Treatment-naive or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
To provide expanded access and to evaluate the safety, tolerability and efficacy of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring Epidermal Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an EGFR tyrosine kinase inhibitor (TKI)
- 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
BIBW2992 low to medium dose once daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
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
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931306
- Sponsor's protocol ID
- 1200.193
- Status last verified
- Nov 2018
- First submitted
- 20 Aug 2013
- Last updated
- 14 Nov 2018
- Results posted
- No
Publications
Park K, Kim JS, Kim JH, Kim YC, Kim HG, Cho EK, Jin JY, Kim M, Marten A, Kang JH. An open-label expanded access program of afatinib in EGFR tyrosine kinase inhibitor-naive patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR mutations. BMC Cancer. 2021 Jul 12;21(1):802. doi: 10.1186/s12885-021-08445-9.
PubMed 34253172
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Expanded Access Program of Afatinib (BIBW 2992) in Treatment-naive or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
- ClinicalTrials.gov ID
- NCT01931306
- Acronym / sponsor ID
- 1200.193
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- First posted
- 29 Aug 2013 (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.
To provide expanded access and to evaluate the safety, tolerability and efficacy of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring Epidermal Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an EGFR tyrosine kinase inhibitor (TKI)
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- locally advanced or metastatic Non-Small Cell Lung Cancer
- Epidermal Growth Factor Receptor mutation positive result per the institution's testing methodology. Any type of EGFR mutation allowed
- Treatment naïve or patients who have received one line of chemotherapy, chemotherapy include neo adjuvant and adjuvant chemotherapy within 1 year from enrolment
- male or female patients age more than 18 years
- Adequate organ function, defined as all of the following:
Key exclusion criteria (21 listed)
- prior treatment with an EGFR tyrosine kinase inhibitor
- 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
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 |
|---|---|---|
| AfatinibBIBW2992 low to medium dose once daily | 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 14 Nov 2018.
- Derived from this study: PubMed 34253172Park K, Kim JS, Kim JH, Kim YC, Kim HG, Cho EK, Jin JY, Kim M, Marten A, Kang JH. An open-label expanded access program of afatinib in EGFR tyrosine kinase inhibitor-naive patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR mutations. BMC Cancer. 2021 Jul 12;21(1):802. doi: 10.1186/s12885-021-08445-9.
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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
8 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 8 sites in South Korea.
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 12 inclusion and 21 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. 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 NCT01931306, 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 14 Nov 2018.