Description:
Adjuvant therapy has been proved effective in treating earlier stage or less advanced
non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as
adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The
primary endpoint is disease-free survival.
Title
- Brief Title: Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation
- Official Title: Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation: a Prospective, Exploratory Study
Clinical Trial IDs
- ORG STUDY ID:
BD-IC-IV57
- NCT ID:
NCT02044328
Conditions
- Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Icotinib | Commana, BPI-2009 | Icotinib |
Purpose
Adjuvant therapy has been proved effective in treating earlier stage or less advanced
non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as
adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The
primary endpoint is disease-free survival.
Trial Arms
Name | Type | Description | Interventions |
---|
Icotinib | Experimental | Patients receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery. | |
Eligibility Criteria
Inclusion Criteria:
- The patients present with operable stage IIA-IIIA (N0-1) lung adenocarcinoma with 19
or 21 exon mutation
- The patients have no history of anti-cancer therapies including chemotherapy,
radiation therapy
- The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1
- The patients signed the written informed consent
Exclusion Criteria:
- Patients with unresected tumor
- Wild EGFR type
- Allergic to the study drug
- Patients have severe non-cancerous diseases
- Patients are undergoing current administration of anti-cancer therapies, or are
attending some other clinical trials
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Disease-free survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | 1-year Survival Rates |
Time Frame: | 1 year |
Safety Issue: | |
Description: | |
Measure: | 3-year Survival Rates |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Measure: | Number of patients suffered adverse events |
Time Frame: | 42 months |
Safety Issue: | |
Description: | Adverse events are evaluated and coded by Common Terminology Criteria for Adverse Events version 4.0 |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Betta Pharmaceuticals Co., Ltd. |
Last Updated
July 4, 2016