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A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

NCT00087711 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1713

Last updated 2019-09-12

No results posted yet for this study

Summary

This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

Conditions

  • Non Small Cell Lung Carcinoma

Interventions

DRUG

pemetrexed

500 mg/m2, IV q 21 days x 6 cycles

DRUG

gemcitabine

1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles

DRUG

cisplatin

75 mg/m2, IV, q 21 days x 6 cycles

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 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
2004-07-31
Primary Completion
2007-01-31
Completion
2008-03-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Puerto Rico
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

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 NCT00087711 on ClinicalTrials.gov