Phase 4
N=107
Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Bottom Line
View on ClinicalTrials.gov: NCT01203917 ↗Enrolled (actual)
107
Serious AEs
19.6%
Results posted
Oct 2013
Primary outcome: Primary: Objective Response Rate (ORR) (Investigator) — 69.8; 30.2 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gefitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) (Investigator) |
69.8; 30.2 | — |
| SECONDARY Disease Control Rate (DCR) (Investigator) |
90.6; 9.4 | — |
| SECONDARY Progression - Free Survival (PFS) (Investigator) |
9.72 | — |
| SECONDARY Overall Survival (OS) |
19.22 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01203917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.