MedTrace Logo

Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC

NCT00254904 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 839

Last updated 2015-03-30

No results posted yet for this study

Summary

To assess the efficacy and safety of PF-3512676 administered in combination with gemcitabine/cisplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of gemcitabine/cisplatin alone.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Cisplatin

Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles

DRUG

Gemcitabine

Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles

DRUG

PF-3512676

PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity

DRUG

Cisplatin

Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles

DRUG

Gemcitabine + Cisplatin

Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Singapore
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • 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 NCT00254904 on ClinicalTrials.gov