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)
Brief 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)

Approved for marketing
Treatment IND/Protocol
Carcinoma, Non-Small-Cell Lung

Drug: Afatinib

BIBW2992 low to medium dose once daily

Eligibility Criteria

Inclusion criteria:

1. locally advanced or metastatic Non-Small Cell Lung Cancer

2. Epidermal Growth Factor Receptor mutation positive result per the institution's
testing methodology. Any type of EGFR mutation allowed

3. Treatment naïve or patients who have received one line of chemotherapy, chemotherapy
include neo adjuvant and adjuvant chemotherapy within 1 year from enrolment

4. male or female patients age more than 18 years

5. Adequate organ function, defined as all of the following:

1. 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.

2. Platelet count more than 75,000 per mm3

3. Serum creatinine below 1.5 times of the upper limit of normal

4. 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.

5. Aspartate Amino Transferase or Alanine Amino Transferase below three times the
upper limit of normal, if related to liver metastases below five times ULN.

6. ECOG score between 0 - 2

7. 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.

Exclusion criteria:

1. prior treatment with an EGFR tyrosine kinase inhibitor

2. 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

3. 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.

4. major surgery within 4 weeks before starting trial treatment or scheduled for surgery
during the projected course of the trial

5. known hypersensitivity to afatinib or any of its excipients

6. 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.

7. 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.

8. childbearing potential who:

1. are nursing or

2. are pregnant or

3. 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

9. 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

10. 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.

11. requiring treatment with any of the prohibited concomitant medications that can not be
stopped for the duration of trial participation

12. known pre-existing interstitial lung disease

13. presence of poorly controlled gastrointestinal disorders that could affect the
absorption of the trial drug

14. active hepatitis B infection, active Hepatitis C infection

15. meningeal carcinomatosis

16. 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Korea, Republic of
Locations

The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon, Korea, Republic of

Gachon University Gil Medical Center
Incheon, Korea, Republic of

Chonnam National University Hwasun Hospital
Jeonnam, Korea, Republic of

Gyeongsang National University Hospital
Jinju, Korea, Republic of

The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, Korea, Republic of

Severance Hospital
Seoul, Korea, Republic of

Samsung Medical Center
Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of

Boehringer Ingelheim, Study Chair
Boehringer Ingelheim

Boehringer Ingelheim
NCT Number
MeSH Terms
Carcinoma, Non-Small-Cell Lung
Afatinib