- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04438902
Osimertinib Combined With Anlotinib in EGFR T790M Mutated NSCLC Patients With Progression on Osimertinib Treatment
A Prospective, Multi-center, Interventional Study of Osimertinib Combined With Anlotinib in Acquired EGFR T790M Mutated NSCLC Patients With Gradual Progression on Osimertinib Treatment
Study Overview
Status
Conditions
Intervention / Treatment
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 progression,there are various clinical explorations,including the continuation of osimertinib with chemotherapy or radiotherapy, osimertinib combined with antiangiogenic agents. In preclinical studies, an overactive vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) pathway and tumour angiogenesis plays a crucial role in the resistance to EGFR-TKIs, and the dual targeting of both the VEGF and EGFR pathways may prevent resistance.
Anlotinib (AL3818) is an inhibitor targeting multiple receptor tyrosine kinases involved in tumour progression, especially VEGFR 2/3, PDGFRα/β and c-Kit. We suppose that the combination treatment of osimertinib and anlotinib may ameliorate acquired resistance to osimertinib.This is a multi-center, open, single-arm, exploratory phase 2 trial evaluating osimertinib combined with anlotinib in acquired EGFR T790M mutated NSCLC patients with gradual progression on osimertinib treatment.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Yuehong Wang
- Phone Number: 13989826233
- Email: yuehongw@zju.edu.cn
Study Contact Backup
- Name: Shan Lu
- Phone Number: 137 5822 2639
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310003
- The First Affiliated Hospital, College of Medicine, Zhejiang University
-
Contact:
- Yuehong Wang, MD
- Phone Number: 13989826233
- Email: yuehongw@zju.edu.cn
-
Jiaxing, Zhejiang, China, 314001
- The First Affiliated Hospital of Jiaxing College
-
Contact:
- Qi Zhang
- Phone Number: 13957382862
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: osimertinib combined with anlotinib
|
osimertinib mesylate tablets 80mg qd and anlotinib hydrochloride capsules 10mg qd day 1-14 of a 21-day cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression-free survival (PFS)
Time Frame: from the date of first dose of osimertinib until the date of disease progression,assessed up to 12 months.
|
PFS is defined as the time from beginning of osimertinib to disease progression on combination treatment of osimertinib and anlotinib.
|
from the date of first dose of osimertinib until the date of disease progression,assessed up to 12 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: from the date of combination of osimertinib and anlotinib, assessed up to 6 weeks.
|
Objective Response Rate (ORR), is defined as the percentage of patients with complete response or partial response by investigator assessment as recorded in the CRF, which usually refer to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 in clinical practice.
|
from the date of combination of osimertinib and anlotinib, assessed up to 6 weeks.
|
Disease Control Rate (DCR)
Time Frame: from the date of combination of osimertinib and anlotinib, assessed up to 6 weeks.
|
Disease Control Rate (DCR), is defined as the percentage of patients with complete response or partial response or stable disease by investigator assessment as recorded in the CRF, which usually refer to RECIST v1.1 in clinical practice.
|
from the date of combination of osimertinib and anlotinib, assessed up to 6 weeks.
|
Adverse events/Serious adverse events
Time Frame: From signing ICF to 30 days after the end of treatment.
|
Incidence of Adverse Events (AEs): Incidence, severity and seriousness of adverse events, incidence of serious adverse events (SAEs), which usually be graded by CTCAE v5.0 based on current clinical practice.
|
From signing ICF to 30 days after the end of treatment.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yuehong Wang, First affiliated Hospital of Zhejiang University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Osimertinib
Other Study ID Numbers
- TRAIN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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