Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients
NCT ID: NCT01719536
Last Updated: 2019-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
296 participants
INTERVENTIONAL
2012-12-31
2017-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Icotinib
Icotinib 125mg is administered orally three times per day.
Icotinib
Icotinib: 125 mg is administered orally three times per day.
Chemotherapy
Patients in this arm will receive pemetrexed/cisplatin for 4 cycles, of who don't progress will receive maintenance treatment with pemetrexed.
Chemotherapy
First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.
Interventions
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Icotinib
Icotinib: 125 mg is administered orally three times per day.
Chemotherapy
First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive EGFR Mutation.
* No previous systemic anticancer therapy.
* Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
* Provision of written informed consent.
Exclusion Criteria
* Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
* Known severe hypersensitivity to icotinib or any of the excipients of this product.
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
18 Years
75 Years
ALL
No
Sponsors
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Betta Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Shi Yuankai, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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The First Affiliated Hospital of Anhui Medical Univercity
Hefei, Anhui, China
Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, China
Beijing Hospital for Chest Tumors & Tuberculosis Diseases
Beijing, Beijing Municipality, China
Xinqiao Hospital, The Third Military Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital Of Guangzhou Medical Collage
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Hebei Provincal Tumor Hospital
Shijiazhuang, Hebei, China
Harbin Medical Univercity Cancer Hospital
Harbin, Heilongjiang, China
Henan Provincal Tumor Hospital
Zhengzhou, Henan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Provincal Tumor Hospital
Nanjing, Jiangsu, China
The First Bethune Hospital of Jilin Univercity
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shanghai Chest Hospital Affiliated to Shanghai Jiaotong Univercity
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Affiliated to Fudan Univercity
Shanghai, Shanghai Municipality, China
Changhai Hospital, The Second Military Medical University
Shanghai, Shanghai Municipality, China
Xijing Hospital
Xian, Shanxi, China
Sichuan Provincal Tumor Hospital
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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References
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Shi YK, Wang L, Han BH, Li W, Yu P, Liu YP, Ding CM, Song X, Ma ZY, Ren XL, Feng JF, Zhang HL, Chen GY, Han XH, Wu N, Yao C, Song Y, Zhang SC, Song W, Liu XQ, Zhao SJ, Lin YC, Ye XQ, Li K, Shu YQ, Ding LM, Tan FL, Sun Y. First-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma (CONVINCE): a phase 3, open-label, randomized study. Ann Oncol. 2017 Oct 1;28(10):2443-2450. doi: 10.1093/annonc/mdx359.
Other Identifiers
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BD-IC-IV36
Identifier Type: -
Identifier Source: org_study_id
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