Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01929200|
Recruitment Status : Unknown
Verified May 2015 by Betta Pharmaceuticals Co., Ltd..
Recruitment status was: Recruiting
First Posted : August 27, 2013
Last Update Posted : May 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Non-small-cell Lung Cancer||Drug: 1-year treatment with icotinib Drug: 2-year treatment with icotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Open-label, Multicenter Study of Icotinib as Adjuvant Therapy in Treating Stage II-IIIA Non-small-cell Lung Cancer Patients With Positive EGFR Mutation|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||August 2017|
Experimental: 1-year treatment with icotinib
Patients will receive 1-year treatment with icotinib after operation.
Drug: 1-year treatment with icotinib
Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 1 year.
Experimental: 2-year treatment with icotinib
Patients will receive 2-year treatment with icotinib after operation.
Drug: 2-year treatment with icotinib
Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 2 years.
- Recurrence-free Survival [ Time Frame: 6 months ]
- Overall survival [ Time Frame: 6 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): NCT01929200
|Contact: Yue Yang, MDemail@example.com|
|Beijing Cancer hospital||Recruiting|
|Beijing, China, 100142|
|Contact: Yue Yang, MD 86-10-88196568 firstname.lastname@example.org|
|Principal Investigator: Yue Yang, MD|
|Principal Investigator:||Yue Yang, MD||Beijing Cancer Hospital|