Osimertinib Combined With Anlotinib in EGFR T790M Mutated NSCLC Patients With Progression on Osimertinib Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04438902|
Recruitment Status : Not yet recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: osimertinib mesylate tablets and anlotinib hydrochloride capsules||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a multi-center, open, single-arm, exploratory phase 2 trial.|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multi-center, Interventional Study of Osimertinib Combined With Anlotinib in Acquired EGFR T790M Mutated NSCLC Patients With Gradual Progression on Osimertinib Treatment|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
|Experimental: osimertinib combined with anlotinib||
Drug: osimertinib mesylate tablets and anlotinib hydrochloride capsules
osimertinib mesylate tablets 80mg qd and anlotinib hydrochloride capsules 10mg qd day 1-14 of a 21-day cycle
Other Name: TAGRISSO and FOCUS V
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04438902
|Contact: Yuehong Wangfirstname.lastname@example.org|
|Contact: Shan Lu||137 5822 2639|
|The First Affiliated Hospital, College of Medicine, Zhejiang University|
|Hangzhou, Zhejiang, China, 310003|
|Contact: Yuehong Wang, MD 13989826233 email@example.com|
|Zhejiang Provincial People's Hospital|
|Hangzhou, Zhejiang, China, 310014|
|Contact: Liqin Lu 13858039628|
|The First Affiliated Hospital of Jiaxing College|
|Jiaxing, Zhejiang, China, 314001|
|Contact: Qi Zhang 13957382862|
|Principal Investigator:||Yuehong Wang||First Affiliated Hospital of Zhejiang University|