Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma
- Conditions
- AdenocarcinomaEGFR Positive Non-small Cell Lung Cancer
- Interventions
- Drug: Placebo
- Registration Number
- NCT02125240
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Brief Summary
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 124
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 1 tablet three times daily by mouth Icotinib Icotinib 125 mg three times daily (375 mg per day) by mouth
- Primary Outcome Measures
Name Time Method Disease-free survival 36 months 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
Name Time Method Overall survival 60 months 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.
Lung cancer symptoms and health-related quality of life (HRQoL) differences 60 months Number of participants with adverse events 36 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (11)
304 Hospital of PLA
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Cancer Hospital, Chinese Academy of Medical Science
🇨🇳Beijing, Beijing, China
People's Liberation Army General Hospital (301 Hospital)
🇨🇳Beijing, Beijing, China
Capital Medical University, Beijing Chest Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Beijing Chaoyang Hospital
🇨🇳Beijing, Beijing, China
Beijing Union Medical College Hospital
🇨🇳Beijing, Beijing, China
China-japan friendship hospital in Beijing
🇨🇳Beijing, Beijing, China
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China