Phase 3
Completed N=399
Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients
Source: ClinicalTrials.gov NCT01040780 ↗Enrolled (actual)
399
Serious AEs
7.0%
Results posted
May 2012
Primary outcomePrimary: Progression Free Survival — 4.6; 3.4 months
Summary
The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
4.6; 3.4 | — |
| SECONDARY Overall Survival |
13.3; 13.9 | — |
| SECONDARY Best Tumor Response |
0.5; 0; 27.1; 27.2; 47.7; 47.7 | — |
| SECONDARY Time To Progression |
5.2; 3.7 | — |
| SECONDARY Safety and Tolerability |
166; 165; 121; 140; 13; 15 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).
- Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment; =.
Exclusion Criteria
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
Data sourced from ClinicalTrials.gov (NCT01040780). 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.