High Dose Versus Routine Dose Icotinib in Advanced Non-small Cell Lung Cancer Patients With Stable Disease

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Routine dose icotinib; Drug: Higher dose icotinib

• Registration Number: NCT02027090
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief Summary

We hypothesize that higher dose icotinib is related with better efficacy. The primary objective is to compare the progression-free survival of higher dose and routine dose of icotinib in treating pretreated advanced non-small cell lung cancer patients with stable disease after 8-week routine dose icotinib treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-01
• Study First Submitted QC: 2014-01-01
• Study First Posted: 2014-01-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology);
• Pretreated with at least 1 platinum-based chemotherapy;
• No previous targeted treatment such as gefitinib, erlotinib;
• With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria;
• WHO performance status(PS)<= 2;
• Adequate organ functions;
• Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria

• Allergic to icotinib;
• Patients with metastatic brain tumors with symptoms;
• Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab;
• Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine dose icotinib	Routine dose icotinib	Patients with stable disease after 8-week routine dose icotinib treatment, are administered with icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity.
Higher dose icotinib	Higher dose icotinib	Patients with stable disease after 8-week routine dose icotinib treatment, are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 375 mg three times per day, till progressive disease or unaccepted toxicity.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	5 months

Secondary Outcome Measures

Name	Time	Method
Response rate assessed using the RECIST criteria	2 months
Overall survival	18 months
The number of patients who suffered adverse events	30 months	Adverse events are assessed by Common Terminology Criteria for Adverse Events v4.0

Trial Locations

Locations (1)

Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China