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

A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00071188

Enrollment

Unknown

Registered

2003-10-16

Start date

2004-02-29

Completion date

2007-10-31

Last updated

2016-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-Small-Cell Lung Carcinoma

Brief 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.

Interventions

DRUGZD6474

DRUGPaclitaxel

DRUGCarboplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Exclusion 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

Countries

Finland, France, Germany, India, Italy, South Africa, Spain, Thailand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026