Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21

Non-small Cell Lung Cancer Clinical Trial

— RECEL  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01714908
• Other study ID #: ML28545
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 23, 2012
• Last updated: February 4, 2017
• Start date: December 14, 2012
• Est. completion date: October 20, 2018

Study information

• Verified date: February 2017
• Source: Shandong Cancer Hospital and Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 20, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Other:
• Erlotinib w Concurrent Radiotherapy

• etoposide/cis-platin (EP) w Concurrent Radiotherapy
Etoposide / Cis-platin w Concurrent Radiotherapy

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Institute & Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	The General Hospital of the People's Liberation Army	Beijing	Beijing
China	West China Hospital, West China School of Medicine, Sichuan University	Chengdu	Sichuan
China	Fujian Province Cancer Hospital	Fuzhou	Fujian
China	Guizhou Cancer Hospital	Guiyang	Guizhou
China	The First People's Hospital of Hangzhou	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Shandong Cancer Hospital and Institute	Jinan	Shandong
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Hebei Medical University Fourth Hospital	Shijiazhuang	Hebei
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Jinming Yu	Roche Pharma AG

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress Free Survival (PFS)	The time frame from the randomization to the first confirmed disease progression or any cause to death (dependent on which comes first)	5 years