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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 July 2021 |
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Main ID: |
NCT02448797 |
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Date of registration:
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15/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation
EVIDENCE |
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Scientific title:
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Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA Non-small Cell Lung Cancer With EGFR-mutation: a Randomized, Positive-controlled, Phase 3 Study (EVIDENCE, CCTC-1501) |
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Date of first enrolment:
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June 8, 2015 |
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Target sample size:
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320 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02448797 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Jianxing He, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Affiliated Hospital of Guangzhou Medical University |
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Name:
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Caicun Zhou, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shanghai Pulmonary Hospital, Shanghai, China |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pathologically confirmed non-small cell lung cancer after surgical resection
- Stage II-IIIA disease according to 7th edition of TNM staging
- Positive EGFR gene mutation (19/21)
- ECOG 0-1
- At least 1-year life expectancy
- Adequate organ function
Exclusion Criteria:
- Previous systemic anti-tumor therapy, including chemotherapy or targeted
therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine
kinase inhibitor, etc
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with
the exception of basal cell carcinoma or cervical cancer in situ
- Pneumonectomy of right lung
- Any unresolved chronic toxicity from previous anticancer therapy
- Allergic to study drug
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non-small Cell Lung Cancer
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Intervention(s)
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Drug: Icotinib
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Drug: Chemotherapy
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Primary Outcome(s)
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disease free survival
[Time Frame: 48 months]
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Secondary Outcome(s)
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overall survival
[Time Frame: 60 months]
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Secondary ID(s)
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BD-IC-IV-61
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CCTC-1501
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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