Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy

Non-small Cell Lung Cancer Clinical Trial

Official title:

Safety and Efficacy of Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy: a Single-arm, Phase 3 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486354
• Other study ID #: BD-IC-III01-V2
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2015
• Last updated: June 28, 2015
• Start date: March 2010
• Est. completion date: April 2012

Study information

• Verified date: June 2015
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after failure of at least one platinum-based chemotherapy regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced/metastatic (stage IIIB/stage IV, using the American Joint Committee on Cancer [AJCC] 6th edition of tumor-node-metastasis [TNM] staging system) NSCLC patients

• Progressed after at least one platinum-based chemotherapy regimen at entry

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

• At least one measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.0

• Adequate hematologic and biochemical values

Exclusion Criteria:

• Patients with symptomatic brain metastases

• Malignant tumor within the previous five years

• Severe infection; congestive heart failure

• Previous treatment with drugs targeting EGFR

• History of interstitial lung disease

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• icotinib
Patients were administered with oral icotinib (tablet form, 125 mg) three times daily within two days after enrollment until disease progression or unacceptable toxicity.

Locations

Country	Name	City	State
China	307 Hospital of PLA	Beijing	Beijing
China	Beijing Chest Hospital	Beijing	Beijing
China	Bejing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital, Chinese Academy of Medical Science	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Third Affiliated Hospital, Third Military Medical University	Chongqing	Chongqing
China	Sun yat-sen Univerisity Cancer Center	Guanzhou	Guangdong
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

Shi Y, Zhang L, Liu X, Zhou C, Zhang L, Zhang S, Wang D, Li Q, Qin S, Hu C, Zhang Y, Chen J, Cheng Y, Feng J, Zhang H, Song Y, Wu YL, Xu N, Zhou J, Luo R, Bai C, Jin Y, Liu W, Wei Z, Tan F, Wang Y, Ding L, Dai H, Jiao S, Wang J, Liang L, Zhang W, Sun Y. I — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		6 months	No
Secondary	overall survival		12 months	No
Secondary	objective response rate		2 months	No
Secondary	number of patients suffered adverse events		15 months	Yes