EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma
Conditions
Brief summary
The study was to evaluate the safety, PFS and ORR of icotinib/dihydroaremisinin (DHA)-based combination therapy in EGFR-mutated, advanced NSCLC patients who have gradually progressed disease after first-line icotinib treatment.
Interventions
DRUGIcotinib combined dihydroaremisinin
Icotinib should be taken by the patients continuously until disease progressed or intolerable toxicity. On day 1-3, oral dihydroaremisinin was given at 20mg per day, the dose of dihydroaremisinin is increased to 40mg daily on day 4 to 6, and 80mg twice daily until disease progressed or intolerable toxicity.
Sponsors
Betta Pharmaceuticals Co., Ltd.
Peking University Cancer Hospital & Institute
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
1. Patients confirmed with stage IV lung adenocarcinoma by pathologic histology or cytology who can't accept surgery and radiotherapy 2. Male or female patients aged ≥18 years, life expectancy ≥ 12 weeks 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 4. Sensitive EGFR gene mutation(19/21) 5. Failed with first-line icotinib and have gradually progressed disease More than 6-month duration of first-line icotinib (from the first dosing to the imaging-confirmed progression; and discontinuation of icotinib is less than 14 days) No significantly increased tumor size compared with the final imaging evaluation
Exclusion criteria
1. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease) 2. Female subjects should not be pregnant or breast-feeding 3. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol 4. Previous systemic anti-tumor therapy except for icotinib , including chemotherapy or targeted therapy ( including but not limited to monoclonal or antibodies, small molecule tyrosine kinase inhibitor, etc) 5. Tumor metastasis of the spinal cord, meninges or meningeal neoplasms confirmed by imaging or cerebrospinal fluid examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival | 18 months |
| Objective response rate | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | 24 months |
Countries
China
Contacts
Primary ContactZiping Wang, MD
Outcome results
None listed