Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients
Convince
Conmana Versus Pemetrexed-based First-line Induction and Maintenance Chemotherapy in Advanced Lung Adenocarcinoma With EGFR-mutation
1 other identifier
interventional
296
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2012
Typical duration for phase_3
21 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
October 29, 2012
CompletedFirst Posted
Study publicly available on registry
November 1, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2017
CompletedJuly 5, 2019
July 1, 2019
3.8 years
October 29, 2012
July 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
12 months
Secondary Outcomes (2)
Overall survival
20 months
Objective response rate
12 weeks
Study Arms (2)
Icotinib
EXPERIMENTALIcotinib 125mg is administered orally three times per day.
Chemotherapy
ACTIVE COMPARATORPatients in this arm will receive pemetrexed/cisplatin for 4 cycles, of who don't progress will receive maintenance treatment with pemetrexed.
Interventions
Icotinib: 125 mg is administered orally three times per day.
First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
The First Affiliated Hospital of Anhui Medical Univercity
Hefei, Anhui, 230022, China
Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, 100853, China
Beijing Hospital for Chest Tumors & Tuberculosis Diseases
Beijing, Beijing Municipality, 101149, China
Xinqiao Hospital, The Third Military Medical University
Chongqing, Chongqing Municipality, 400037, China
The First Affiliated Hospital Of Guangzhou Medical Collage
Guangzhou, Guangdong, 510120, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Hebei Provincal Tumor Hospital
Shijiazhuang, Hebei, 050011, China
Harbin Medical Univercity Cancer Hospital
Harbin, Heilongjiang, 110001, China
Henan Provincal Tumor Hospital
Zhengzhou, Henan, 450003, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Jiangsu Provincal Tumor Hospital
Nanjing, Jiangsu, 210029, China
The First Bethune Hospital of Jilin Univercity
Changchun, Jilin, 130021, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Shanghai Chest Hospital Affiliated to Shanghai Jiaotong Univercity
Shanghai, Shanghai Municipality, 200030, China
Zhongshan Hospital Affiliated to Fudan Univercity
Shanghai, Shanghai Municipality, 200032, China
Changhai Hospital, The Second Military Medical University
Shanghai, Shanghai Municipality, 200433, China
Xijing Hospital
Xian, Shanxi, 710032, China
Sichuan Provincal Tumor Hospital
Chengdu, Sichuan, 610041, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Related Publications (1)
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.
PMID: 28945850RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shi Yuankai, M.D.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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
October 29, 2012
First Posted
November 1, 2012
Study Start
December 1, 2012
Primary Completion
September 1, 2016
Study Completion
February 7, 2017
Last Updated
July 5, 2019
Record last verified: 2019-07