Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation
EVIDENCE
2 other identifiers
interventional
320
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer
Started Jun 2015
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2015
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedStudy Start
First participant enrolled
June 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJuly 20, 2021
October 1, 2020
7.1 years
May 15, 2015
July 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
disease free survival
the time from the date of randomization to the first observation of tumor recurrence, metastasis (based on imaging ) or death
48 months
Secondary Outcomes (1)
overall survival
60 months
Study Arms (2)
icotinib
EXPERIMENTAL125 mg three times daily (375 mg per day) orally for two years.
standard chemotherapy
ACTIVE COMPARATORVinorelbine 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
125 mg three times daily (375 mg per day) orally for two years.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
307 Hospital of PLA
Beijing, Beijing Municipality, 100071, China
Fujian Provincal Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital Of Guangzhou Medical Collage
Guangzhou, Guangdong, 510120, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 150081, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, 310000, China
Related Publications (2)
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.
PMID: 40421698DERIVEDHe 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.
PMID: 34280355DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Caicun Zhou, MD
Shanghai Pulmonary Hospital, Shanghai, China
- STUDY CHAIR
Jianxing He, MD
The First Affiliated Hospital of Guangzhou Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2015
First Posted
May 19, 2015
Study Start
June 8, 2015
Primary Completion
June 30, 2022
Study Completion
December 1, 2023
Last Updated
July 20, 2021
Record last verified: 2020-10