Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation
NCT ID: NCT02448797
Last Updated: 2021-07-20
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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UNKNOWN
PHASE3
320 participants
INTERVENTIONAL
2015-06-08
2023-12-31
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
125 mg three times daily (375 mg per day) orally for two years.
Icotinib
125 mg three times daily (375 mg per day) orally for two years.
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.
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.
Interventions
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Icotinib
125 mg three times daily (375 mg per day) orally for two years.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 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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Caicun Zhou, MD
Role: STUDY_CHAIR
Shanghai Pulmonary Hospital, Shanghai, China
Jianxing He, MD
Role: STUDY_CHAIR
The First Affiliated Hospital of Guangzhou Medical University
Locations
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307 Hospital of PLA
Beijing, Beijing Municipality, China
Fujian Provincal Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital Of Guangzhou Medical Collage
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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References
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Occhipinti M, Imbimbo M, Ferrara R, Simeon V, Fiscon G, Marchal C, Skoetz N, Viscardi G. Adjuvant epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) for the treatment of people with resected stage I to III non-small-cell lung cancer and EGFR mutation. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015140. doi: 10.1002/14651858.CD015140.pub2.
He J, Su C, Liang W, Xu S, Wu L, Fu X, Zhang X, Ge D, Chen Q, Mao W, Xu L, Chen C, Hu B, Shao G, Hu J, Zhao J, Liu X, Liu Z, Wang Z, Xiao Z, Gong T, Lin W, Li X, Ye F, Liu Y, Ma H, Huang Y, Zhou J, Wang Z, Fu J, Ding L, Mao L, Zhou C. Icotinib versus chemotherapy as adjuvant treatment for stage II-IIIA EGFR-mutant non-small-cell lung cancer (EVIDENCE): a randomised, open-label, phase 3 trial. Lancet Respir Med. 2021 Sep;9(9):1021-1029. doi: 10.1016/S2213-2600(21)00134-X. Epub 2021 Jul 21.
Other Identifiers
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CCTC-1501
Identifier Type: OTHER
Identifier Source: secondary_id
BD-IC-IV-61
Identifier Type: -
Identifier Source: org_study_id
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