Dose Escalation Of Icotinib In Previously Treated Patients With Routine Dose

Phase 4

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Icotinib

• Registration Number: NCT01465243
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief Summary

To determine whether dose escalation can provide a better survival to patients who failed with icotinib at routine dose.

Detailed Description

Lung cancer is a major cause of morbidity and mortality, which is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years. Tyrosine kinase inhibitors (TKIs) of the epidermal growth factor receptor (EGFR) have been widely used for the treatment of patients with non-small cell lung cancer(NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. Icotinib appears to be non-inferior to Gefitinib in terms of efficacy, better in terms of safety, and larger of therapeutic window in phase I-III trials. In this study, an open , single-center, single arm phase IV trial was designed to evaluate the safety and efficacy of dose escalation of icotinib in the treatment of advanced NSCLC patients after failure with routine dose. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-03
• Study First Posted: 2011-11-04
• Primary Completion: 2013-10
• Status Verified: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-13
• Last Update Posted: 2014-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).
2. 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.
3. Measurable, evaluable disease outside of a radiation port.

Exclusion Criteria

1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
2. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Icotinib	Icotinib	This is a single arm study.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	6-12 months

Secondary Outcome Measures

Name	Time	Method
Objective response rate	3-6 months
Time to progression	3-6 months
Health-Related Quality of Life (HR QOL)	1 year
Overall survival	6 months -1 year
Number of Participants with adverse events and serious adverse events (SAEs)	1 year

Trial Locations

Locations (1)

307 Hospital of People's Liberation Army（PLA）; 🇨🇳 Beijing, Beijing, China