Phase 4
Completed 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
Source: ClinicalTrials.gov NCT01203917 ↗
Enrolled (actual)
107
Serious AEs
19.6%
Results posted
Oct 2013
Primary outcomePrimary: Objective Response Rate (ORR) (Investigator) — 69.8; 30.2 Percentage of Participants
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.
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 | — |
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. Informational only — not medical advice.