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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
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

Brief Summary:
This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.

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

Detailed Description:
Adjuvant therapy has been proved effective in treating stage II-IIIA non-small-cell lung cancer. However, few data on the treating time of adjuvant therapy is available. Here we conduct a randomized, prospective study to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib in EGFR-mutated non-small cell lung cancer patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • Commana
  • BPI-2009

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.
Other Names:
  • Commana
  • BPI-2009




Primary Outcome Measures :
  1. Recurrence-free Survival [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients signed the written informed consent
  • The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation
  • The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
  • The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2

Exclusion Criteria:

  • Patients with unresected tumor
  • Wild EGFR type
  • Allergic to the study drug
  • Patients have severe non-cancerous diseases
  • Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials

Information from the National Library of Medicine

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


Contacts
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Contact: Yue Yang, MD 86-10-88196568 zlyangyue@bjmu.edu.cn

Locations
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China
Beijing Cancer hospital Recruiting
Beijing, China, 100142
Contact: Yue Yang, MD    86-10-88196568    zlyangyue@bjmu.edu.cn   
Principal Investigator: Yue Yang, MD         
Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.
Investigators
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Principal Investigator: Yue Yang, MD Beijing Cancer Hospital
Publications:
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Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01929200    
Other Study ID Numbers: BD-IC-IV50
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms