Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Drug: Chemoradiotherapy
- Registration Number
- NCT02215356
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemoradiotherapy 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. Icotinib with concurrent radiotherapy 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.
- Primary Outcome Measures
Name Time Method Progression-free survival 24 months
- Secondary Outcome Measures
Name Time Method Overall survival 36 months Objective response rate 8 weeks Adverse events 54 months
Trial Locations
- Locations (26)
Chinese Academy of Medical Sciences Cancer Hospital
🇨🇳Beijing, Beijing, China
People's Liberation Army 307 Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Dongguan City People's Hospital
🇨🇳Dongguan, Guangdong, China
Sun Yat-sen Cancer Hospital
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
Guangxi Zhuang Autonomous Region People's Hospital
🇨🇳Nanning, Guangxi, China
Cancer Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
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