A Study of Alimta/Cisplatin/Gefitinib for Asian Non-smoking Participants With Non Small Cell Lung Cancer

Launched by ELI LILLY AND COMPANY · Nov 19, 2009

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histological diagnosis of NSCLC with locally advanced or metastatic disease that is of non-squamous histology.
• • Participants must be "light ex-smokers" or "never-smokers".
• • "Light ex-smokers" defined as having ceased smoking for greater than or equal to 5 years and not to have exceeded 10 pack-years.
• • "Never-smokers" are defined as having smoked \<100 cigarettes or equivalent during his/her lifetime.
• • Participants must be of East Asian ethnicity.
• • No prior systemic therapy for lung cancer.
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Exclusion Criteria:
• • Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
• • Any evidence of clinically active interstitial lung disease. Asymptomatic participants with chronic, stable, radiographic changes are eligible.
• • Participants whose Epidermal Growth Factor Receptor (EGFR) mutation status is known prior to study entry will be excluded. Participants in which EGFR mutation testing has not been performed, or whose EGFR mutation status is unknown or inconclusive at study entry are eligible.