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Completed

NCT Number: NCT00252707

Iressa 2nd Line Phase III Study in Japan

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gefitinib or Docetaxel

Drug

Primary outcomes

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

Secondary outcomes

  1. Determine the followings as the secondary outcome variables:

  2. - Progression-free survival (PFS)

  3. - Time to treatment failure (TTF)

  4. - Objective tumour response (CR, PR) and the disease control rate (CR, PR, SD [≥12 weeks]) based on the RECIST guidelines

  5. - Lung cancer subscale (LCS)

  6. - QOL according to FACT-L questionnaire

  7. - Frequency and severity of adverse events.

  8. Determine the followings as the exploratory outcome variables:

  9. - Biomarkers related to expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways

  10. - 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Nov 15, 2005
Registry last updated
Dec 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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