Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Untreated Advanced Non-small-cell Lung Cancer: a Randomized, Open-label Study
Overview
- Phase
- Phase 4
- Intervention
- Sequential and maintenance icotinib
- Conditions
- EGFR Positive Non-small Cell Lung Cancer
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Progression Free Survival
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Sequential and 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.
Intervention: Maintenance icotinib
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: 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 Outcomes
- Overall survival(24 months)
- Objective response rate(24 months)
- Disease control rate (DCR)(24 months)
- Adverse events(24 months)