Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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Icotinib With Concurrent Radiotherapy Versus Etoposide/Cisplatin With Concurrent Radiotherapy in Stage III Non-small Cell Lung Cancer With EGFR 19/21 Mutation

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Icotinib with concurrent radiotherapy
* Drug: Chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chemoradiotherapy<br>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. | Drug: Chemoradiotherapy<br>* Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles<br>* Other names: DDP;|
| Experimental: Icotinib with concurrent radiotherapy<br>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. | Drug: Icotinib with concurrent radiotherapy<br>* Icotinib: 125 mg is administered orally three times per day.<br>* Other names: BPI-2009;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 36 months | 
| Objective response rate |  | 8 weeks | 
| Adverse events |  | 54 months |