High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation

Phase 4

• Conditions: NSCLC
• Interventions: Drug: icotinib

• Registration Number: NCT02404675
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief Summary

This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-31
• Study Start: 2015-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-28
• Primary Completion: 2017-12
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
• Positive EGFR 21 exon mutation or 19 exon deletion
• Age 18-75 years old with performance status of 0 to 2
• With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria
• Adequate hematological, biochemical and organ functions.

Exclusion Criteria

• Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
• Evidence of interstitial lung diseases
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
21 icotinib (125mg)	icotinib	Patients with EGFR 21 exon positive are randomly assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity
21 icotinib (250mg)	icotinib	Patients with EGFR 21 exon positive are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 250 mg three times per day, till progressive disease or unaccepted toxicity.
19 icotinib (125mg)	icotinib	Patients with EGFR del 19 exon positive are assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity

Primary Outcome Measures

Name	Time	Method
Progression-free survival	12 months

Secondary Outcome Measures

Name	Time	Method
Objective response rates	12 weeks
Overall survival	20 months

Trial Locations

Locations (1)

Beijing Chest Hospital, Capital Medical University; 🇨🇳 Beijing, China