Icotinib With Concurrent Radiotherapy Versus Etoposide/Cisplatin With Concurrent Radiotherapy in Stage III Non-small Cell Lung Cancer With EGFR 19/21 Mutation
Overview
- Phase
- Phase 2
- Intervention
- Chemoradiotherapy
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Enrollment
- 120
- Locations
- 26
- Primary Endpoint
- Progression-free survival
- Last Updated
- 11 years ago
Overview
Brief Summary
This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cell lung cancer
Detailed Description
This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent radiotherapy in stage III non-small cell lung cancer with EGFR 19/21 Mutation, the primary endpoint is progression-free survival
Investigators
Eligibility Criteria
Inclusion Criteria
- •Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation
- •No previous systemic anticancer therapy
- •Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
- •ECOG Performance Status of 0 to 1
Exclusion Criteria
- •Prior treatment with anti-EGFR (the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as gefitinib, erlotinib or cetuximab
- •Evidence of clinically active Interstitial Lung Diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- •Known severe hypersensitivity to icotinib or any of the excipients of this product
Arms & Interventions
Chemoradiotherapy
Etoposide 50mg/m2, ivgtt, d1-d5, cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles, while chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times). Progressive patients will be administered oral icotinib 125 mg three times daily.
Intervention: Chemoradiotherapy
Icotinib with concurrent radiotherapy
Chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times), while icotinib 125mg three times daily (375 mg per day) by mouth. Maintenance icotinib will be administered after radiotherapy. Progressive patients will receive chemotherapy, using the platinum-based two-drug chemotherapy regimen.
Intervention: Icotinib with concurrent radiotherapy
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 24 months
Secondary Outcomes
- Overall survival(36 months)
- Objective response rate(8 weeks)
- Adverse events(54 months)