A Multiple Center, Open-label, Randomized Phase III Study to Evaluate the Efficacy and Safety of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as the First-line Treatment for Stage IIIB/IV NSCLC Patients With Mutations in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor (EGFR) in Their Tumor
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
A Multiple Center, Open-label, Randomized Phase III Study to Evaluate the Efficacy and Safety of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as the First-line Treatment for Stage IIIB/IV NSCLC Patients With Mutations in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor (EGFR) in Their Tumor
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell
lung cancer
- Presence of Epidermal Growth Factor Receptor (EGFR) mutations in tumours
- Measurable disease according to RECIST criteria
- European Cooperative Oncology Group (ECOG) performance status
Exclusion Criteria:
- Prior exposure to agents directed at the human epidermal receptor (HER) axis (e.g.
but not limited to erlotinib, gefitinib, cetuximab, trastuzumab)
- Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption
syndrome, or inability to take oral medication, or active gastroduodenal ulcer
disease
- Any inflammatory changes of the surface of the eye
- >/= grade 2 peripheral neuropathy
- History of any other malignancies within 5 years, except for adequately treated
carcinoma in situ of the cervix or basal or squamous cell skin cancer
- Brain metastasis or spinal cord compression that has not yet been definitely treated
with surgery and/or radiation, or treated but without evidence of stable disease for
at least 2 months
- HIV infection
- Pregnant, nursing or lactating women
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival (tumor assessments according to RECIST criteria)
Outcome Time Frame:
approximately 21 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
China: Ministry of Health
Study ID:
YO25121
NCT ID:
NCT01342965
Start Date:
March 2011
Completion Date:
December 2013
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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