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Iressa 2nd Line Phase III Study in Japan

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Gefitinib or Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00252707
D791AL00001
V-15-32

Details and patient eligibility

About

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.

Enrollment

484 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

40

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Data sourced from clinicaltrials.gov

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