A Multicentre, Randomised, Open-Label, Parallel-Group, Phase III Post-Marketing Clinical Study to Compare the Overall Survival Between Gefitinib and Docetaxel in Patients With Advanced or Metastatic (Stage IIIB/IV), or Recurrent Non-Small Cell Lung Cancer, Who Have Failed One or Two Chemotherapy Regimens

AstraZeneca1 site in 1 country484 target enrollmentSeptember 2003

ConditionsNon-Small Cell Lung Cancer

DrugsGefitinib or Docetaxel

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Non-Small Cell Lung Cancer
Sponsor: AstraZeneca
Enrollment: 484
Locations: 1
Primary Endpoint: Determine the overall survival with these treatments as the primary outcome.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

November 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•You are "histologically" or "cytologically" confirmed to have recurrent or metastatic NSCLC
•You have been treated with chemotherapy including platinums for NSCLC.

Exclusion Criteria

•You have received treatment for non-small lung cancer within 4 weeks before your participation in this study (except for specific therapies)
•You have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, pulmonary pneumonia, or pneumoconiosis evident on the X-ray
•You have or had any disease of radiation pneumonia or drug-induced pneumonia, which requires treatment with corticosteroids

Outcomes

Primary Outcomes

Determine the overall survival with these treatments as the primary outcome.

Secondary Outcomes

- Biomarkers related to expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways
Determine the followings as the secondary outcome variables:
- Progression-free survival (PFS)
- Time to treatment failure (TTF)
- Objective tumour response (CR, PR) and the disease control rate (CR, PR, SD [≥12 weeks]) based on the RECIST guidelines
- Lung cancer subscale (LCS)
- QOL according to FACT-L questionnaire
- Frequency and severity of adverse events.
Determine the followings as the exploratory outcome variables:
- Biomarkers related to somatic (non-inheritable) mutation analyses of genes of the ErbB family, their signalling pathways and associated pathways which are thought to be influenced by gefitinib in tumour cells.