ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Study summary

The purpose of the run-in phase of this study is to determine the appropriate and tolerable dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment. The purpose of the randomized phase of this study is to determine the efficacy of ZD6474 alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedZD6474 and Paclitaxel

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 25, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?34 U.S. locations

Locations may change over time.

Who runs it?Genzyme, a Sanofi Company

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Genzyme, a Sanofi Company
Interventions being studied: Drug: ZD6474; Drug: Paclitaxel; Drug: Carboplatin

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Locally advanced→Metastatic or stage IV→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Signed informed consent
18 years or older
Histologically or cytologically confirmed locally advanced or metastatic NSCLC
No prior chemotherapy/biological therapy/radiation therapy
One or more measurable lesions
Life expectancy more than 12 weeks

Reasons someone may not be able to joinExclusion criteria

Brain metastases or spinal cord compression
Currently active skin disease
History of significant hemoptysis
Abnormal blood chemistry
Cardiac abnormalities
Recent significant cardiac event
Coexisting malignancies

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Research SiteConcord, California
Research SiteLos Angeles, California
Research SiteChicago, Illinois
Research SiteBoston, Massachusetts
Research SiteSt Louis, Missouri
Research SiteProvidence, Rhode Island
Research SiteNashville, Tennessee
Research SiteAustin, Texas
Research SiteHouston, Texas
Research SiteLubbock, Texas
Research SiteNorfolk, Virginia
Research SiteSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 25, 2016. Always confirm current availability with the study team.

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