Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02215356|
Recruitment Status : Unknown
Verified August 2014 by Betta Pharmaceuticals Co., Ltd..
Recruitment status was: Active, not recruiting
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Icotinib with concurrent radiotherapy Drug: Chemoradiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Icotinib With Concurrent Radiotherapy Versus Etoposide/Cisplatin With Concurrent Radiotherapy in Stage III Non-small Cell Lung Cancer With EGFR 19/21 Mutation|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||February 2019|
Active Comparator: 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.
Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles
Experimental: 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.
Drug: Icotinib with concurrent radiotherapy
Icotinib: 125 mg is administered orally three times per day.
- Progression-free survival [ Time Frame: 24 months ]
- Overall survival [ Time Frame: 36 months ]
- Objective response rate [ Time Frame: 8 weeks ]
- Adverse events [ Time Frame: 54 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215356
|Principal Investigator:||Lvhua Wang, MD||Chinese Academy of Medical Sciences|
|Principal Investigator:||Xiaolong Fu, MD||Shanghai Chest Hospital|