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Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma (ICWIP)

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: NCT02125240
Recruitment Status : Unknown
Verified July 2018 by Betta Pharmaceuticals Co., Ltd..
Recruitment status was:  Recruiting
First Posted : April 29, 2014
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

Brief Summary:
The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Condition or disease Intervention/treatment Phase
EGFR Positive Non-small Cell Lung Cancer Adenocarcinoma Drug: Icotinib Drug: Placebo Phase 3

Detailed Description:

This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Primary Outcome Measure:

Disease-free survival between Icotinib group and placebo group.

Secondary Outcome Measures:

Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Icotinib as an Adjuvant Therapy for Stage II-IIIA Adenocarcinoma With EGFR Mutation: A Placebo-controlled, Randomized, Double-blind, Phase III Study
Study Start Date : September 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Icotinib
125 mg three times daily (375 mg per day) by mouth
Drug: Icotinib
125 mg three times daily (375 mg per day) by mouth
Other Names:
  • BPI-2009
  • Conmana

Active Comparator: Placebo
1 tablet three times daily by mouth
Drug: Placebo
1 tablet three times daily by mouth




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 36 months ]
    DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 60 months ]
    OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.

  2. Lung cancer symptoms and health-related quality of life (HRQoL) differences [ Time Frame: 60 months ]
  3. Number of participants with adverse events [ Time Frame: 36 months ]


Information from the National Library of Medicine

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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:

  • Pathologically confirmed lung adenocarcinoma after surgical resection
  • Stage II-IIIA disease according to 7th edition of TNM staging
  • Patients must harbor sensitive EGFR gene mutation (19/21)
  • Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy

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
  • Presence of metastatic disease
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Any unresolved chronic toxicity from previous anticancer therapy
  • Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)

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): NCT02125240


Contacts
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Contact: Yuan-Kai Shi, MD 010-87788293

Locations
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China, Beijing
Beijing Chaoyang Hospital Recruiting
Beijing, Beijing, China, 100000
Principal Investigator: Hui Li, MD         
Beijing Hospital Recruiting
Beijing, Beijing, China, 100005
Principal Investigator: Gang Cheng, MD         
Beijing Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100005
Principal Investigator: Li Zhang, MD         
Cancer Hospital, Chinese Academy of Medical Science Recruiting
Beijing, Beijing, China, 100021
Principal Investigator: Yuan-Kai Shi, MD         
China-japan friendship hospital in Beijing Recruiting
Beijing, Beijing, China, 100029
Principal Investigator: De-Ruo Liu, MD         
Peking University First Hospital Not yet recruiting
Beijing, Beijing, China, 100034
Principal Investigator: Jian Li, MD         
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Principal Investigator: Jun Wang, MD         
304 Hospital of PLA Recruiting
Beijing, Beijing, China, 100048
Principal Investigator: Wen-Hua Xiao, MD         
Xuanwu Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100053
Principal Investigator: Xiu-Yi Zhi, MD         
People's Liberation Army General Hospital (301 Hospital) Not yet recruiting
Beijing, Beijing, China, 100853
Principal Investigator: Yi Hu, MD         
Capital Medical University, Beijing Chest Hospital Recruiting
Beijing, Beijing, China, 101149
Principal Investigator: Shu-Cai Zhang, MD         
Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.
Investigators
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Principal Investigator: Yuan-Kai Shi, MD Cancer Hospital, Chinese Academy of Medical Science
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02125240    
Other Study ID Numbers: BD-IC-IV-59
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type