Iressa 2nd Line Phase III study in Japan

Study identifier:D791AL00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official 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

Medical condition

Non-small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Gefitinib or Docetaxel

Sex

All

Actual Enrollment

484

Study type

Interventional

Age

20 Years +

Date

Study Start Date: 01 Sept 2003
Primary Completion Date: -
Study Completion Date: 01 Nov 2006

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria