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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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ClinicalTrials.gov Identifier: NCT02448797
Recruitment Status : Recruiting
First Posted : May 19, 2015
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

Study Description
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Brief Summary:
Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage II-IIIA non-small cell lung cancer patients with EGFR mutation. The primary endpoint is disease-free survival.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Icotinib Drug: Chemotherapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 8, 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Vinorelbine

Arms and Interventions
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Arm Intervention/treatment
Experimental: icotinib
125 mg three times daily (375 mg per day) orally for two years.
 Drug: Icotinib
125 mg three times daily (375 mg per day) orally for two years.
Other Name: Conmana
Active Comparator: standard chemotherapy

Vinorelbine 25 mg/m^2, intravenously guttae, day 1 and day 8, 21 days/cycle, 4 cycles.

cisplatin 75 mg/m^2, intravenously guttae, day 1, 21 days/cycle, 4 cycles.

For adenocarcinoma: pemetrexed (500 mg/m^2, day 1)/cisplatin (75 mg/m^2, day 1) for 4 cycles.

 Drug: Chemotherapy
Vinorelbine 25 mg/m^2, intravenously guttae, day 1 and day 8, 21 days/cycle, 4 cycles, cisplatin 75 mg/m^2, intravenously guttae, day 1, 21 days/cycle, 4 cycles. For adenocarcinoma: pemetrexed (500 mg/m^2, day 1)/cisplatin (75 mg/m^2, day 1) for 4 cycles.
Other Names:
  • Navelbine
  • ALIMTA


Outcome Measures
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Primary Outcome Measures :
  1. disease free survival [ Time Frame: 48 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 60 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02448797


Contacts
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Contact: Caicun Zhou, MD 13301825532
Contact: Jianxing He, MD 13802777270

Locations
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China, Beijing
307 Hospital of PLA Recruiting
Beijing, Beijing, China, 100071
Principal Investigator: Xiao-qing Liu, M.D.         
China, Fujian
Fujian Provincal Cancer Hospital Recruiting
Fuzhou, Fujian, China, 350014
Contact: Huang Cheng, M.D.    0086-13905010397      
Principal Investigator: Huang Cheng, M.D.         
China, Guangdong
The First Affiliated Hospital Of Guangzhou Medical Collage Recruiting
Guangzhou, Guangdong, China, 510120
Contact: He Jianxing    0086-13802777270      
Principal Investigator: He Jianxing, M.D.         
Shenzhen People's Hospital Recruiting
Shenzhen, Guangdong, China, 518020
Contact: Zheng Wang, MD    13502886638      
Principal Investigator: Zheng Wang, MD         
China, Liaoning
The First Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110001
Contact: Liu Yunpeng, M.D.    0086-13898865122      
Principal Investigator: Liu Yunpeng, M.D.         
First Affiliated Hospital of China Medical University Active, not recruiting
Shenyang, Liaoning, China, 150081
China, Shanghai
Shanghai Pulmonary Hospital Recruiting
Shanghai, Shanghai, China, 200433
Principal Investigator: Cai-Cun Zhou         
China, Zhejiang
The First Affiliated Hospital of Medical School of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Zhou Jianying, M.D.    0086-13750881678    drzjy@163.com   
Principal Investigator: Zhou Jianying, M.D.         
Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.
Investigators
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Study Chair: Caicun Zhou, MD Shanghai Pulmonary Hospital, Shanghai, China
Study Chair: Jianxing He, MD The First Affiliated Hospital of Guangzhou Medical University
More Information
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Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02448797    
Other Study ID Numbers: BD-IC-IV-61
CCTC-1501 ( Other Identifier: China Clinical Trial Consortium )
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
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
Vinorelbine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action