CRC 12127: 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)
- Type of Study
- Cancer (Oncology) - Lung
- Location
- Swedish Cancer Institute
- Short Description
Purpose: 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.
- Status
- Open to Enrollment
- Principal Investigator
- Howard (Jack) West, M.D.
- Eligibility Notes
- Locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
- Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution's testing methodology
- ECOG score between 0 – 2
- No 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)
- No 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
- No active hepatitis B infection, active Hepatitis C (HEP C) infection and/or known Human Immunodeficiency Virus (HIV) carrier
- No meningeal carcinomatosis
- More Info Link
- Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
- Phone
- (206) 215-3086
- CancerResearch@swedish.org
