Status:
UNKNOWN
Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Plasma EGFR Mutation-positive Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 10 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03346811
Start Date
November 18 2017
End Date
March 10 2020
Last Update
November 17 2017
Active Locations (1)
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1
National Cancer Center/Cancer Hospital
Beijing, Beijing Municipality, China, 100021