Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

Icotinib With Concurrent Radiotherapy Versus Etoposide/Cisplatin With Concurrent Radiotherapy in Stage III Non-small Cell Lung Cancer With EGFR 19/21 Mutation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02215356
• Other study ID #: BD-IC-IV66
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 11, 2014
• Last updated: August 11, 2014
• Start date: August 2014
• Est. completion date: February 2019

Study information

• Verified date: August 2014
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent radiotherapy in stage III non-small cell lung cancer with EGFR 19/21 Mutation, the primary endpoint is progression-free survival

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: February 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Icotinib with concurrent radiotherapy
Icotinib: 125 mg is administered orally three times per day.
• Chemoradiotherapy
Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles

Locations

Country	Name	City	State
China	Beijing Union Medical College Hospital	Beijing	Beijing
China	Chinese Academy of Medical Sciences Cancer Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	People's Liberation Army 307 Hospital	Beijing	Beijing
China	Tumor Hospital of Jilin Province	Changchun	Jilin
China	Hunan Provincial Tumor Hospital	Changsha	Hunan
China	Sichuan Provincial Tumor Hospital	Chengdu	Sichuan
China	Dongguan City People's Hospital	Dongguan	Guangdong
China	Nanfang Hospital	Guangzhou	Guangdong
China	Sun Yat-sen Cancer Hospital	Guangzhou	Guangdong
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Cancer Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Tumor Hospital of Yunnan Province	Kunming	Yunnan
China	Jiangxi Provincial Cancer Hospital	Nanchang	Jiangxi
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Guangxi Zhuang Autonomous Region People's Hospital	Nanning	Guangxi
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Fudan University Cancer Hospital	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Liaoning Provincial Tumor Hospital	Shenyang	Liaoning
China	Shanxi Tumor Hospital	Taiyuan	Shanxi
China	Tianjin Cancer Hospital	Tianjin	Tianjin
China	Tongji Hospital	Wuhan	Hubei
China	First Affiliated Hospital of Xinjiang Medical University	Wulumuqi	Xinjiang
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		24 months	No
Secondary	Overall survival		36 months	No
Secondary	Objective response rate		8 weeks	No
Secondary	Adverse events		54 months	Yes