Description:
The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and
placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
Title
- Brief Title: Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma
- Official Title: Icotinib as an Adjuvant Therapy for Stage II-IIIA Adenocarcinoma With EGFR Mutation: A Placebo-controlled, Randomized, Double-blind, Phase III Study
Clinical Trial IDs
- ORG STUDY ID:
BD-IC-IV-59
- NCT ID:
NCT02125240
Conditions
- EGFR Positive Non-small Cell Lung Cancer
- Adenocarcinoma
Interventions
| Drug | Synonyms | Arms |
|---|
| Icotinib | BPI-2009, Conmana | Icotinib |
| Placebo | | Placebo |
Purpose
The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and
placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
Detailed Description
This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and
placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
Primary Outcome Measure:
Disease-free survival between Icotinib group and placebo group.
Secondary Outcome Measures:
Overall survival between Icotinib group and placebo group. Lung cancer symptoms and
health-related quality of life (HRQoL) . Number of participants with adverse events.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Icotinib | Experimental | 125 mg three times daily (375 mg per day) by mouth | |
| Placebo | Active Comparator | 1 tablet three times daily by mouth | |
Eligibility Criteria
Inclusion Criteria:
- Pathologically confirmed lung adenocarcinoma after surgical resection
- Stage II-IIIA disease according to 7th edition of TNM staging
- Patients must harbor sensitive EGFR gene mutation (19/21)
- Received four cycles of platinum-based adjuvant chemotherapy.There are many different
kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel,
paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy
with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the
dose of chemotherapy
Exclusion Criteria:
- Previous systemic anti-tumor therapy, including chemotherapy or targeted
therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine
kinase inhibitor, etc
- Presence of metastatic disease
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with
the exception of basal cell carcinoma or cervical cancer in situ
- Any unresolved chronic toxicity from previous anticancer therapy
- Received antitumor radiation therapy (except for the stage IIIA N2 patients who
received adjuvant radiotherapy after surgery)
| 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: | 36 months |
| Safety Issue: | |
| Description: | DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression. |
Secondary Outcome Measures
| Measure: | Overall survival |
| Time Frame: | 60 months |
| Safety Issue: | |
| Description: | OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive. |
| Measure: | Lung cancer symptoms and health-related quality of life (HRQoL) differences |
| Time Frame: | 60 months |
| Safety Issue: | |
| Description: | |
| Measure: | Number of participants with adverse events |
| Time Frame: | 36 months |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Betta Pharmaceuticals Co., Ltd. |
Last Updated
July 16, 2018
