NCT03346811UnknownPhase 2
Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer：a Single Arm，Multi-center，Open-label Study
Betta Pharmaceuticals Co., Ltd.1 site in 1 country120 target enrollmentStarted: November 18, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- ORR
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Experimental: icotinib
Experimental
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
Intervention: Icotinib (Drug)
Outcomes
Primary Outcomes
ORR
Time Frame: 12 weeks
Objective Response Rate
Secondary Outcomes
- PFS(12 months)
- OS(20 months)
- DCR(12 months)
Investigators
Study Sites (1)
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