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Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)

NCT00102804 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 663

Last updated 2014-12-29

Study results available
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Summary

This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care in NSCLC. Participants must have received 1 of 6 induction regimens for 4 cycles and did not have progressive disease prior to randomization (enrollment) into this trial.

Conditions

Interventions

DRUG

Pemetrexed

500 milligrams per square meter (mg/m\^2), intravenous (IV) administration, every (q) 21 days, until disease progression

DRUG

Placebo

IV administration, q 21 days

OTHER

Best Supportive Care

Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.

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
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2007-08-31
Completion
2013-12-31

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Bulgaria
  • China
  • Croatia
  • Czechia
  • Germany
  • Greece
  • Hungary
  • India
  • Italy
  • Netherlands
  • Poland
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00102804 on ClinicalTrials.gov