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

Phase 3

• Conditions: on-Small Cell Lung Cancer

• Registration Number: JPRN-jRCT1080220402
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Ages Eligible for Study: 20 Years and above,
Genders Eligible for Study: Both
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy Primary Outcomes: Determine the overall survival with these treatments as the primary outcome. Secondary Outcomes: 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 expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways; - 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.