Clinical trial NCT01719536: Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients
Official title: Conmana Versus Pemetrexed-based First-line Induction and Maintenance Chemotherapy in Advanced Lung Adenocarcinoma With EGFR-mutation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: NSCLC
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-11-01
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.

Detailed description: This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall survival, time to progression, and so on.

Eligibility criteria: Inclusion Criteria:

* Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
* 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:

* Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
* 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 12 months
Secondary outcomes:
measure: Overall survival
timeFrame: 20 months
measure: Objective response rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical Univercity
state: Anhui
city: Beijing
country: China
facility: Chinese People's Liberation Army (PLA) General Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital for Chest Tumors & Tuberculosis Diseases
state: Beijing
city: Chongqing
country: China
facility: Xinqiao Hospital, The Third Military Medical University
state: Chongqing
city: Guangzhou
country: China
facility: The First Affiliated Hospital Of Guangzhou Medical Collage
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei Provincal Tumor Hospital
state: Hebei
city: Harbin
country: China
facility: Harbin Medical Univercity Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincal Tumor Hospital
state: Henan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Provincal Tumor Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin Univercity
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Chest Hospital Affiliated to Shanghai Jiaotong Univercity
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan Univercity
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital, The Second Military Medical University
state: Shanghai
city: Xian
country: China
facility: Xijing Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincal Tumor Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Shi Yuankai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.