Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer

Phase 2

• Conditions: Plasma EGFR Mutation-positive Lung Cancer
• Interventions: Drug: Icotinib

• Registration Number: NCT03346811
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief Summary

this single arm，open-label，multi-center study is aimed to evaluate the efficiency of icotinib in plasma ctDNA EGFR mutation-positive patients diagnosed with lung cancer

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-15
• Study First Submitted QC: 2017-11-15
• Last Update Submitted: 2017-11-15
• Study First Posted: 2017-11-17
• Last Update Posted: 2017-11-17
• Study Start: 2017-11-18
• Primary Completion: 2019-05-10
• Study Completion: 2020-03-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Clinical diagnosis of peripheral lung cancer, but the pathological diagnosis is not yet clear.
• Plasma EGFR mutations (EGFR 19del and/or 21L858R) positive (simultaneously detected by Super-ARMS, ddPCR and NGS，any positive).
• unavailable of radical surgery or radical radiotherapy.
• not previously received anticancer therapy like surgery, chemotherapy, radiation therapy, and biotherapy etc.
• Palliative radiotherapy for bone metastases is permitted, but there is no continuous toxicity associated with radiation therapy.
• Age 18-75 years old with performance status of 0 to 3.
• With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)) according to RECIST Criteria.None of the lesions treated with radiotherapy could be used as target lesions.
• 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
• Other situations researchers think not appropriate to enter the group

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: icotinib	Icotinib	Patients diagnosed with lung cancer with plasma EGFR mutation-positive are arranged 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
ORR	12 weeks	Objective Response Rate

Secondary Outcome Measures

Name	Time	Method
PFS	12 months	Progression-free survival
OS	20 months	overall survival
DCR	12 months	disease control rate

Trial Locations

Locations (1)

National Cancer Center/Cancer Hospital; 🇨🇳 Beijing, Beijing, China