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

Phase 2

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT01714908
• Lead Sponsor: Jinming Yu

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-26
• Study Start: 2012-12-14
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-04
• Last Update Posted: 2017-02-07
• Primary Completion: 2018-08-20
• Study Completion: 2018-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progress Free Survival (PFS)	5 years	The time frame from the randomization to the first confirmed disease progression or any cause to death (dependent on which comes first)

Trial Locations

Locations (19)

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

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

The General Hospital of the People's Liberation Army; 🇨🇳 Beijing, Beijing, China

Fujian Province Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

Guizhou Cancer Hospital; 🇨🇳 Guiyang, Guizhou, China

Hebei Medical University Fourth Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

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