Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy

Phase 3

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: icotinib

• Registration Number: NCT02486354
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-10
• Study Completion: 2012-04
• Status Verified: 2015-06
• Study First Submitted: 2015-06-28
• Study First Submitted QC: 2015-06-28
• Last Update Submitted: 2015-06-28
• Study First Posted: 2015-07-01
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
icotinib	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.

Primary Outcome Measures

Name	Time	Method
progression-free survival	6 months

Secondary Outcome Measures

Name	Time	Method
overall survival	12 months
objective response rate	2 months
number of patients suffered adverse events	15 months

Trial Locations

Locations (10)

307 Hospital of PLA; 🇨🇳 Beijing, Beijing, China

Jiangsu Cancer Hospital; 🇨🇳 Nanjing, Jiangsu, China

Third Affiliated Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

Cancer Hospital, Chinese Academy of Medical Science; 🇨🇳 Beijing, Beijing, China

Beijing Chest Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of College of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Sun yat-sen Univerisity Cancer Center; 🇨🇳 Guanzhou, Guangdong, China

Bejing Cancer Hospital; 🇨🇳 Beijing, Beijing, China