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

NCT01017874 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2015-07-08

Study results available
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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).

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Pemetrexed

500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles.

DRUG

Cisplatin

75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles

DRUG

Gefitinib

250 milligrams (mg) administered orally once a day, every day of 21-day cycle, for maintenance in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy

DRUG

Gefitinib

250 milligrams (mg) administered orally once a day, every day of 21-day cycles administered as a monotherapy

Sponsors & Collaborators

Principal Investigators

  • 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) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-04-30
Completion
2014-10-31

Countries

  • Hong Kong
  • Singapore
  • South Korea
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01017874 on ClinicalTrials.gov