Phase 2
Completed N=46
First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
Pulmonary Cancer
Source: ClinicalTrials.gov NCT00344773 ↗
Enrolled (actual)
46
Serious AEs
—
Results posted
Jun 2010
Primary outcomePrimary: Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria. — 0 Percent of Participants
Summary
The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria. |
— | — |
| SECONDARY Progression Free Survival (PFS) |
86.25 | — |
| SECONDARY Overall Survival (OS) |
82.26 | — |
| SECONDARY Safety Profile: Participants With Adverse Events |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00344773). 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.