An Open-label Multi-center Study of Erlotinib (Tarceva®) as First Line Therapy Until and Beyond Disease Progression in NSCLC Patients Who Harbour EGFR Mutations
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
An Open-label Multi-center Study of Erlotinib (Tarceva®) as First Line Therapy Until and Beyond Disease Progression in NSCLC Patients Who Harbour EGFR Mutations
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Stage IV or recurrent non-small cell lung cancer (NSCLC)
- Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor
receptor (EGFR), (except T790M single mutation only)
- Measurable disease (at least one lesion >= 10 mm in longest diameter)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hematological, renal and liver function
Exclusion Criteria:
- Patients with T790M single mutation only
- Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g.
erlotinib, gefitinib, cetuximab, trastuzumab
- Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease
- Symptomatic or uncontrolled central nervous system (CNS) metastases
- Other malignancy within the last 5 years, except for carcinoma in situ of the cervix,
or basal or squamous cell carcinoma of the skin, or surgically treated localized
prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast
- Any significant ophthalmologic abnormality
- Pre-existing parenchymal lung disease such as pulmonary fibrosis
- Use of coumarins (for anti-coagulation therapy the use of low molecular weight
heparin is recommended instead)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival by RECIST (PFS1), defined as time from first dose until documented RECIST disease progression or death of any cause at any time, whichever occurs first
Outcome Time Frame:
42 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Korea: Korea FDA
Study ID:
ML25637
NCT ID:
NCT01310036
Start Date:
April 2011
Completion Date:
December 2013
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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