Overview

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

Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare two different approaches to treating non-small cell lung cancer (NSCLC) in East Asian never-smoker participants. Half of the participants will receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti-cancer agent (gefitinib) and the other half of the participants will receive only the oral anti-cancer agent (gefitinib).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Cisplatin
Gefitinib
Pemetrexed
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.