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

Lilly

Status and phase: Completed; Phase 3

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Cisplatin; Drug: Pemetrexed; Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01017874

13021

H3E-CR-S131 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 236 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

Pemetrexed + Cisplatin + Gefitinib

Experimental group

Treatment:

Drug: Gefitinib

Drug: Pemetrexed

Drug: Cisplatin

Drug: Gefitinib

Gefitinib

Active Comparator group

Treatment:

Drug: Gefitinib

Drug: Gefitinib