First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Pulmonary Cancer

Treatments: Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00344773

D7913L00056

Details and patient eligibility

About

The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.

Enrollment: 46 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis
• WHO Performance Status 0-2
• No prior chemotherapy, biological or immunological therapy/surgery

Exclusion criteria

• Any evidence of clinically active interstitial lung disease
• Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation
• Patients with previously diagnosed and treated CNS metastases or spinal cord compression

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Gefitinib

Experimental group

Description:

Gefitinib 250mg tablet once daily

Treatment:

Drug: Gefitinib