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

NCT ID: NCT02215356

Last Updated: 2014-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2019-02-28

Brief Summary

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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

Detailed Description

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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

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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, 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.

Group Type ACTIVE_COMPARATOR

Chemoradiotherapy

Intervention Type DRUG

Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles

Icotinib with concurrent radiotherapy

Chest 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.

Group Type EXPERIMENTAL

Icotinib with concurrent radiotherapy

Intervention Type DRUG

Icotinib: 125 mg is administered orally three times per day.

Interventions

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Icotinib with concurrent radiotherapy

Icotinib: 125 mg is administered orally three times per day.

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Icotinib Comana BPI-2009 VP16 DDP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lvhua Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Xiaolong Fu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

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Chinese Academy of Medical Sciences Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

People's Liberation Army 307 Hospital

Beijing, Beijing Municipality, China

Site Status

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Dongguan City People's Hospital

Dongguan, Guangdong, China

Site Status

Sun Yat-sen Cancer Hospital

Guangzhou, Guangdong, China

Site Status

Nanfang Hospital

Guangzhou, Guangdong, China

Site Status

Guangxi Zhuang Autonomous Region People's Hospital

Nanning, Guangxi, China

Site Status

Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Tongji Hospital

Wuhan, Hubei, China

Site Status

Hunan Provincial Tumor Hospital

Changsha, Hunan, China

Site Status

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Site Status

Nantong Tumor Hospital

Nantong, Jiangsu, China

Site Status

Jiangxi Provincial Cancer Hospital

Nanchang, Jiangxi, China

Site Status

Tumor Hospital of Jilin Province

Changchun, Jilin, China

Site Status

Liaoning Provincial Tumor Hospital

Shenyang, Liaoning, China

Site Status

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status

Shanxi Tumor Hospital

Taiyuan, Shanxi, China

Site Status

Sichuan Provincial Tumor Hospital

Chengdu, Sichuan, China

Site Status

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

Tumor Hospital of Yunnan Province

Kunming, Yunnan, China

Site Status

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Site Status

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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BD-IC-IV66

Identifier Type: -

Identifier Source: org_study_id

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