Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy

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

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: icotinib

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100071
      • 307 Hospital of PLA
    • Beijing, Beijing, China, 101149
      • Beijing Chest Hospital
    • Beijing, Beijing, China, 100021
      • Cancer Hospital, Chinese Academy of Medical Science
    • Beijing, Beijing, China, 100036
      • Bejing Cancer Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Third Affiliated Hospital, Third Military Medical University
  • Guangdong
    • Guanzhou, Guangdong, China, 510060
      • Sun Yat-Sen Univerisity Cancer Center
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Shanghai Pulmonary Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • The First Affiliated Hospital of College of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Conmana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression-free survival	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	12 months
objective response rate	2 months
number of patients suffered adverse events	15 months

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Study Chair: Yan Sun, MD, Cancer Hospital, Chinese Academy of Medical Science

Publications and helpful links

General Publications

• 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. Icotinib versus gefitinib in previously treated advanced non-small-cell lung cancer (ICOGEN): a randomised, double-blind phase 3 non-inferiority trial. Lancet Oncol. 2013 Sep;14(10):953-61. doi: 10.1016/S1470-2045(13)70355-3. Epub 2013 Aug 13.
• Hu X, Zhang L, Shi Y, Zhou C, Liu X, Wang D, Song Y, Li Q, Feng J, Qin S, Xv N, Zhou J, Zhang L, Hu C, Zhang S, Luo R, Wang J, Tan F, Wang Y, Ding L, Sun Y. The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study. PLoS One. 2015 Nov 24;10(11):e0142500. doi: 10.1371/journal.pone.0142500. eCollection 2015.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: June 28, 2015
• First Submitted That Met QC Criteria: June 28, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Estimate): July 1, 2015
• Last Update Submitted That Met QC Criteria: June 28, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: BD-IC-III01-V2