Status:
TERMINATED
Osimertinib Combined With Anlotinib in EGFR T790M Mutated NSCLC Patients With Progression on Osimertinib Treatment
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
EGFR T790M gatekeeper mutation accounts for approximately 60% of acquired resistance to the first- or second-generation EGFR-TKI treatment. Osimertinib, a third-generation EGFR TKI, has become the sta...
Detailed Description
In current clinical practice, acquired resistance to osimertinib can be divided into three clinical modes: dramatic progression, gradual progression and local progression. For patients with gradual pr...
Eligibility Criteria
Inclusion
- Ability to provide informed consent, complete all study assessments and have complete medical record.
- Age:18-75 years.
- Histologically or cytologically confirmed diagnosis of local advanced or metastatic NSCLC.
- Patients should be confirmed acquired EGFR T790M mutation and received osimertinib as the second line treatment, and they should have the following: (1) benefit from treatment with osimertinib initially ;(2) gradual progression on osimertinib treatment as defined by minor increment of tumor burden (≥10% but \<20% in the sum of target lesions).
- At least one measurable lesion as defined by lesions ≥10mm in long axis according to RECIST 1.1.
Exclusion
- Patients who will be or were involved in any other interventional antitumour clinical studies for locally advanced/metastatic NSCLC currently or previously.
- Small cell lung cancer (including small lung cancer mixed with non-small cell lung cancer).
- Patients at risk of bleeding.
- Patients with renal dysfunction.
- Uncontrolled severe hypertension.
- Any concomitant condition evaluated by physicians which is not suitable for osimertinib or anlotinib treatment.
Key Trial Info
Start Date :
December 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04438902
Start Date
December 12 2020
End Date
February 16 2023
Last Update
February 21 2023
Active Locations (2)
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1
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
2
The First Affiliated Hospital of Jiaxing College
Jiaxing, Zhejiang, China, 314001