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

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Chemoradiotherapy; Drug: Icotinib with concurrent radiotherapy

• Registration Number: NCT02215356
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

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

Detailed 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

Study Timeline

• Status Verified: 2014-08
• Study Start: 2014-08
• Study First Submitted: 2014-08-11
• Study First Submitted QC: 2014-08-11
• Last Update Submitted: 2014-08-11
• Study First Posted: 2014-08-13
• Last Update Posted: 2014-08-13
• Primary Completion: 2018-08
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemoradiotherapy	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.
Icotinib with concurrent radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	24 months

Secondary Outcome Measures

Name	Time	Method
Objective response rate	8 weeks
Overall survival	36 months
Adverse events	54 months

Trial Locations

Locations (26)

Beijing Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Dongguan City People's Hospital; 🇨🇳 Dongguan, Guangdong, China

Guangxi Zhuang Autonomous Region People's Hospital; 🇨🇳 Nanning, Guangxi, China

Cancer Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Sun Yat-sen Cancer Hospital; 🇨🇳 Guangzhou, Guangdong, China

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Hunan Provincial Tumor Hospital; 🇨🇳 Changsha, Hunan, China

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China

Jiangxi Provincial Cancer Hospital; 🇨🇳 Nanchang, Jiangxi, China

Nantong Tumor Hospital; 🇨🇳 Nantong, Jiangsu, China

Jiangsu Cancer Hospital; 🇨🇳 Nanjing, Jiangsu, China

Chinese Academy of Medical Sciences Cancer Hospital; 🇨🇳 Beijing, Beijing, China

People's Liberation Army 307 Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Tumor Hospital of Jilin Province; 🇨🇳 Changchun, Jilin, China

First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Wulumuqi, Xinjiang, China

Liaoning Provincial Tumor Hospital; 🇨🇳 Shenyang, Liaoning, China

Sichuan Provincial Tumor Hospital; 🇨🇳 Chengdu, Sichuan, China

Shanxi Tumor Hospital; 🇨🇳 Taiyuan, Shanxi, China

Tianjin Cancer Hospital; 🇨🇳 Tianjin, Tianjin, China

Tumor Hospital of Yunnan Province; 🇨🇳 Kunming, Yunnan, China