Trial Information
A Phase 2 Trial of Pemetrexed and Cisplatin Followed Sequentially by Gefitinib Versus Pemetrexed and Cisplatin in Asian "Never Smoker" Patients With Advanced Non-Small Cell Lung Cancer
Inclusion Criteria:
- Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or
IV)
- Have not received any prior chemotherapy, molecular therapy, immunotherapy,
biological therapy, or radiotherapy. Exception: palliative radiotherapy that is
completed at least 4 weeks prior to study enrolment.
- Have 'never smoked' (defined as having smoked <100 cigarettes during his/her
lifetime)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Exclusion Criteria:
- Concurrent administration of any other tumor therapy
- Other co-existing malignancies
- Pregnancy or breast feeding
- Serious concomitant disorders
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
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 (PFS)
Outcome Description:
Defined as the time from randomization to the first observation of disease progression, or death due to any cause.
Outcome Time Frame:
Baseline to first observation of disease progression or death, 12 weeks up to 31 months
Safety Issue:
No
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
China: Food and Drug Administration
Study ID:
10918
NCT ID:
NCT00409006
Start Date:
February 2007
Completion Date:
May 2010
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms