Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC
- Conditions
- EGFR Positive Non-small Cell Lung CancerAdenocarcinoma
- Interventions
- Drug: Sequential and maintenance icotinib
- Registration Number
- NCT02194556
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Brief Summary
This randomised, controlled, open-label, prospective trial is designed to assess the efficacy and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer patients with EGFR mutation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Stage IV or IIIB advanced non-small cell lung cancer patients
- Positive EGFR Mutation
- Non-progressive disease after first-line gemcitabine/cisplatin therapy
- Measurable lesion according to RECIST 1.1 with at least one measurable lesion
- Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on
- Patients with wild-type EGFR
- Evidence of interstitial lung diseases
- Severe hypersensitivity to icotinib or any of the excipients of this product.
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sequential and maintenance icotinib Sequential and maintenance icotinib Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity. Maintenance icotinib Maintenance icotinib Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib (125 mg three times per day) as maintenance treatment until disease progression or intolerable toxicity.
- Primary Outcome Measures
Name Time Method Progression Free Survival 15 months A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
- Secondary Outcome Measures
Name Time Method Overall survival 24 months Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.
Objective response rate 24 months Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Disease control rate (DCR) 24 months Disease control rate including complete response (CR) o，partial response (PR) , stable disease (SD)
Adverse events 24 months The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.
Trial Locations
- Locations (1)
First Affiliated Hospital of Guangxi Medical University
🇨🇳NanNing, Guangxi, China