Overview

Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study is carried out to see how Caucasian patients with lung cancer which has EGFR mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also be collected and analysed to confirm that treatment with gefitinib is safe and well tolerated.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Gefitinib
Criteria
Inclusion Criteria:

- Locally advanced or metastatic non-small cell lung cancer (i.e. cancer that has spread
from where it started) which is EGFR mutation positive

- Caucasian female or male patients aged 18 years or over

- Measurable disease, i.e. at least one lesion, not previously irradiated, as ≥ 10 mm in
the longest diameter (≥ 15 mm in short axis for lymph node )

Exclusion Criteria:

- Prior adjuvant chemotherapy or other systemic anti-cancer treatment less than 6 month,
or palliative radiotherapy less than 4 weeks prior to start of study treatment.

- Brain metastases or spinal cord compression, unless treated and stable without
steroids

- Any clinically significant illness, which will jeopardize the patients' safety and
their participation in the study.