Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer
1 other identifier
interventional
120
1 country
26
Brief Summary
This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cell lung cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Aug 2014
Typical duration for phase_2 nonsmall-cell-lung-cancer
26 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
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 11, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedAugust 13, 2014
August 1, 2014
4 years
August 11, 2014
August 11, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival
24 months
Secondary Outcomes (3)
Overall survival
36 months
Objective response rate
8 weeks
Adverse events
54 months
Study Arms (2)
Chemoradiotherapy
ACTIVE COMPARATOREtoposide 50mg/m2, ivgtt, d1-d5, cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles, while chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times). Progressive patients will be administered oral icotinib 125 mg three times daily.
Icotinib with concurrent radiotherapy
EXPERIMENTALChest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times), while icotinib 125mg three times daily (375 mg per day) by mouth. Maintenance icotinib will be administered after radiotherapy. Progressive patients will receive chemotherapy, using the platinum-based two-drug chemotherapy regimen.
Interventions
Icotinib: 125 mg is administered orally three times per day.
Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles
Eligibility Criteria
You may qualify if:
- Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 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
- ECOG Performance Status of 0 to 1
You may not qualify if:
- Prior treatment with 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, 100021, China
People's Liberation Army 307 Hospital
Beijing, Beijing Municipality, 100039, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Dongguan City People's Hospital
Dongguan, Guangdong, 523059, China
Sun Yat-sen Cancer Hospital
Guangzhou, Guangdong, 510060, China
Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, 530021, China
Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Tongji Hospital
Wuhan, Hubei, 430030, China
Hunan Provincial Tumor Hospital
Changsha, Hunan, 410013, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Nantong Tumor Hospital
Nantong, Jiangsu, 226361, China
Jiangxi Provincial Cancer Hospital
Nanchang, Jiangxi, 330029, China
Tumor Hospital of Jilin Province
Changchun, Jilin, 130012, China
Liaoning Provincial Tumor Hospital
Shenyang, Liaoning, 110042, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032, China
Shanxi Tumor Hospital
Taiyuan, Shanxi, 030013, China
Sichuan Provincial Tumor Hospital
Chengdu, Sichuan, 610041, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Tumor Hospital of Yunnan Province
Kunming, Yunnan, 650118, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lvhua Wang, MD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- PRINCIPAL INVESTIGATOR
Xiaolong Fu, MD
Shanghai Chest Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2014
First Posted
August 13, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2018
Study Completion
February 1, 2019
Last Updated
August 13, 2014
Record last verified: 2014-08