Clinical trial NCT01714908: Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21
Official title: A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Erlotinib Versus Etoposide Plus Cisplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of Epidermal Growth Factor Receptor (EGFR) in Exon 19 or 21
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
EGFR mutation
unresectable
erlotinib
concurrent radiotherapy
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2012-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin with concurrent radiotherapy.


Eligibility criteria: Inclusion Criteria:

* NSCLC confirmed by histopathology or cytology;
* Stage IIA or IIIB NSCLC according to Tumor Node Metastasis (TMN) staging of Lung Staging Standard version 7 2009, and be unresectable;
* Has active mutation of EGFR in exon 19 or 21;
* Has measurable lesion \[according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension \>= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and \>=15mm\];
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
* expectancy life \>= 12 weeks;

Exclusion Criteria:

* Had be treated by HER-targeting agents;
* Had systemic anit-NSCLC treatments;
* Had local radiotherapy for NSCLC;
* Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
* Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
* Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
* Known hypersensitivity to platinum, etoposide, EGFR-Tyrosine Kinase Inhibitor (TKI) agents or relevant components in the formulation;
* Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;

Primary outcomes:
measure: Progress Free Survival (PFS)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute & Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: The General Hospital of the People's Liberation Army
state: Beijing
city: Fuzhou
country: China
facility: Fujian Province Cancer Hospital
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guiyang
country: China
facility: Guizhou Cancer Hospital
state: Guizhou
city: Shijiazhuang
country: China
facility: Hebei Medical University Fourth Hospital
state: Hebei
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, West China School of Medicine, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First People's Hospital of Hangzhou
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Jinming Yu, PhD
role: STUDY_CHAIR
affiliation: The First People's Hospital of Hangzhou
name: Shenglin Ma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongnan Hospital
name: Conghua Xie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Cancer Hospital
name: Ming Chen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongji Medical College, Huazhong University of Science and Technology, Wuhan Union Hospital
name: Gang Wu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Cancer Hospital
name: Jianhua Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fujian Province Cancer Hospital
name: Jiancheng Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Zhengfei Zhu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital, West China School of Medicine, Sichuan University
name: You Lu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Lvhua Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: Guangying Zhu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital
name: Tingyi Xia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebei Medical University Fourth Hospital
name: Chun Han, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Hospital of China Medical University
name: Guang Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Zhiyong Yuan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Xiamen University
name: Qin Lin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Renmin Hospital of Wuhan University
name: Qibin Song, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Cancer Hospital
name: Yaping Xu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Hospital of Guizhou Province
name: Bing Lu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital
name: Baolin Qu, PhD
role: PRINCIPAL_INVESTIGATOR
References: