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

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

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

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Chemoradiotherapy; Drug: Icotinib with concurrent radiotherapy

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100021
      • Chinese Academy of Medical Sciences Cancer Hospital
    • Beijing, Beijing, China, 100039
      • People's Liberation Army 307 Hospital
    • Beijing, Beijing, China, 100730
      • Beijing Union Medical College Hospital
  • Guangdong
    • Dongguan, Guangdong, China, 523059
      • Dongguan City People's Hospital
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen Cancer Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Guangxi Zhuang Autonomous Region People's Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Cancer Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China, 450052
      • First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Provincial Tumor Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
    • Nantong, Jiangsu, China, 226361
      • Nantong Tumor Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Provincial Cancer Hospital
  • Jilin
    • Changchun, Jilin, China, 130012
      • Tumor Hospital of Jilin Province
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Liaoning Provincial Tumor Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Cancer Hospital
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Shanxi Tumor Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Sichuan Provincial Tumor Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Cancer Hospital
  • Xinjiang
    • Wulumuqi, Xinjiang, China, 830000
      • First Affiliated Hospital of Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Tumor Hospital of Yunnan Province
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310006
      • Hangzhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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; Other Names: VP16; DDP
Experimental: 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.	Drug: Icotinib with concurrent radiotherapy; Icotinib: 125 mg is administered orally three times per day.; Other Names: BPI-2009; Icotinib; Comana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	36 months
Objective response rate	8 weeks
Adverse events	54 months

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Lvhua Wang, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: August 11, 2014
• First Submitted That Met QC Criteria: August 11, 2014
• First Posted (Estimate): August 13, 2014

Study Record Updates

• Last Update Posted (Estimate): August 13, 2014
• Last Update Submitted That Met QC Criteria: August 11, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: BD-IC-IV66