Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer

Summary

The current standard of care for unresectable locally advanced non-small-cell lung cancer (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the first self-developed small molecular drug in China for targeted therapy of lung cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in inoperable stage III non-small cell lung cancer with EGFR mutation, the primary endpoint is progression-free survival.

Conditions

• Non-small Cell Lung Cancer

Interventions

DRUG

Icotinib

Icotinib (125 mg ,Three times daily)

DRUG

Pemetrexed

Pemetrexed(500mg/m2)every 21 days

DRUG

Carboplatin

Carboplatin (AUC，5) every 21 days

RADIATION

Thoracic radiotherapy(TRT)

TRT (total dose 66Gy, 2Gy per time, once a day, five times a week, a total of 33 times)

Sponsors & Collaborators

• People's Hospital of Guangxi Zhuang Autonomous Region

  lead OTHER

Principal Investigators

• GuoSheng Feng, MD · The People's hospital of Guangxi Zhuang Autonomous

• Yuan Liang, MD · Guangxi Department of Public Health

• Lin Hui, MD · The People's hospital of Guangxi Zhuang Autonomous

• HeMing Lu, MD · The People's hospital of Guangxi Zhuang Autonomous

• ChangJie Huang, MD · Nanning Second People's Hospital

• GuiSheng LI, MD · Liuzhou Workers' Hospital

• HaiXin Huang, MD · Liuzhou Workers' Hospital

• HaoLin Yan, MD · First People's Hospital of Yulin

• Ping Liang, MD · Guangxi Ruikang Hospital

• BingQiang Ni, MD · The People's hospital of LiuZhou

• YanRong Hao, MD · The People's hospital of Guangxi Zhuang Autonomous

• XianBin Yuan, MD · The People's hospital of Guangxi Zhuang Autonomous

• Shan Gao, MD · The People's hospital of Guangxi Zhuang Autonomous

• Xia Wu, MD · The People's hospital of Guangxi Zhuang Autonomous

• XiangLi Lai, MD · The People's hospital of Guangxi Zhuang Autonomous

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2016-12-31

Completion

2017-12-31

Countries

• China

Study Locations