Clinical Study of Anlotinib in Maintenance Treatment of Advanced NSCLC (CSOAIMTOAN)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03769805|
Recruitment Status : Unknown
Verified October 2019 by The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was: Recruiting
First Posted : December 10, 2018
Last Update Posted : October 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nonsmall Cell Lung Cancer||Drug: Anlotinib||Not Applicable|
This study is planned to be carried out in Jiangsu regional multi-center. 83 cases are preliminarily expected to be included. The study started in December 2018 and ended in December 2019. It is expected that the trial will end in December 2020.
In the absence of such situations as withdrawal of informed consent, intolerance of drug toxicity and side effects, or inappropriateness for further trials, each participant's expected time for research and treatment will continue until radiographically confirmed tumor progression occurs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||83 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Anlotinib in Maintenance Treatment of Advanced NSCLC|
|Actual Study Start Date :||June 15, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Anlotinib Arm
Anlotinib hydrochloride capsule 12 mg, orally, once a day, oral before breakfast, according to the research program for 2 weeks, discontinued for 1 week. Patients with complete remission (CR), partial remission (PR) and stable disease (SD) continued to administer drugs until the disease progressed, intolerable toxicity or withdrawal was required. Patients with progression of illness (PD) discontinued their medication.
Anlotinib hydrochloride capsule 12 mg, orally, once a day, oral before breakfast, according to the research program for 2 weeks, discontinued for 1 week.
- PFS [ Time Frame: 5 month ]Progression free survival
- OS [ Time Frame: through study completion, an average of 18 month ]Overall survival
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): NCT03769805
|Contact: Yongqian Shu, PhDfirstname.lastname@example.org|
|Contact: Yiqian Liu, PhD||008613813804568|
|The First Affiliated Hospital with Nanjing Medical University||Recruiting|
|Nanjing, Jangsu, China|
|Contact: Yongqian Shu, Doctor|
|Contact: Yiqian Liu|
|Study Chair:||Yongqian Shu, professor||JANGSU PROVINCE HOSPITAL|