Status:
UNKNOWN
Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced NSCLC
Lead Sponsor:
Peking University Cancer Hospital & Institute
Collaborating Sponsors:
Betta Pharmaceuticals Co., Ltd.
Conditions:
EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 fir...
Eligibility Criteria
Inclusion
- Patients confirmed with stage IV lung adenocarcinoma by pathologic histology or cytology who can't accept surgery and radiotherapy
- Male or female patients aged ≥18 years, life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Sensitive EGFR gene mutation(19/21)
- 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
- 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)
- Female subjects should not be pregnant or breast-feeding
- Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- 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)
- Tumor metastasis of the spinal cord, meninges or meningeal neoplasms confirmed by imaging or cerebrospinal fluid examination
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 20 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03402464
Start Date
January 1 2018
End Date
September 20 2020
Last Update
January 18 2018
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, China, 100142