Description:
This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in
non-small cell lung cancer patients harboring uncommon EGFR mutation
Title
- Brief Title: Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation
- Official Title: Clinical Activity of Icotinib in Patients With Advanced Non-small-cell Lung Cancer Harbouring Uncommon EGFR Mutations: a Single-arm, Prospective, Phase 2 Study
Clinical Trial IDs
- ORG STUDY ID:
CAMS-ZH-001
- NCT ID:
NCT02961270
Conditions
- Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Icotinib | | icotinib |
Purpose
This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in
non-small cell lung cancer patients harboring uncommon EGFR mutation
Trial Arms
Name | Type | Description | Interventions |
---|
icotinib | Experimental | patients will be administered study drug (icotinib) until disease progression or unacceptable toxicity | |
Eligibility Criteria
Inclusion Criteria:
- Patients with stage IIIB/IV non-small cell lung cancer
- Patients with uncommon epidermal growth factor receptor (EGFR) mutation
- Targeted-therapy-naive patients
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Evaluable target lesions according to RECIST 1.1 for tumour response assessment
Exclusion Criteria:
- Wild-type EGFR
- Positive 19 del and/or 21 L858R mutation
- Previous treatment with EGFR TKIs such as gefitinib, erlotinib, and afatinib
- Patients who have documented history of interstitial lung disease
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | progression-free survival |
Time Frame: | 10 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | tumor response rate |
Time Frame: | 2 months |
Safety Issue: | |
Description: | |
Measure: | overall survival |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Chinese Academy of Medical Sciences |
Last Updated
November 11, 2016