Clinical trial NCT02448797: Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-19
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: disease free survival
timeFrame: 48 months
Secondary outcomes:
measure: overall survival
timeFrame: 60 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: 307 Hospital of PLA
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincal Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital Of Guangzhou Medical Collage
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: First Affiliated Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Medical School of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Caicun Zhou, MD
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Jianxing He, MD
role: STUDY_CHAIR
References:
citation: 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.