Plasma EGFR Mutation-positive Lung Cancer
Conditions
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
Interventions
DRUGIcotinib
Patients 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
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 12 weeks | Objective Response Rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 12 months | Progression-free survival |
| DCR | 12 months | disease control rate |
| OS | 20 months | overall survival |
Countries
China
Contacts
Primary ContactJie Wang, MD
Backup ContactZhijie Wang, MD
Outcome results
None listed