Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small Cell Lung Cancer | Drug: Anlotinib Hydrochloride | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Study of Anlotinib Single Drug as the Maintenance Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) |
Actual Study Start Date : | March 5, 2019 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: anlotinib |
Drug: Anlotinib Hydrochloride
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.
|
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Routine blood test ANC≥1.5 x 109/L; PLT≥100 x 109/L; Hb≥90g/L Blood biochemistry TBIL≤1.5 x ULN ALT and AST≤2 x ULN; for patients with liver metastases, ALT and AST ≤5 x ULN; BUN and Cr≤1.5 x ULN and creatinine clearance≥50 ml/min;LVEF≥50%; 12 lead electrocardiogram The Fridericia-corrected QTcF was < 450 ms for males and < 470 MS for females.
Exclusion Criteria:
Medical history and combined history
China, Jilin | |
First Hospital of Jilin University | Recruiting |
Chang chun, Jilin, China, 130013 | |
Contact: jiuwei cui, M.D. Ph.D. 043188783173 cuijiuwei@vip.qq.com |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | June 23, 2019 | ||||
First Posted Date ICMJE | June 25, 2019 | ||||
Last Update Posted Date | July 30, 2020 | ||||
Actual Study Start Date ICMJE | March 5, 2019 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
PFS [ Time Frame: 5 months ] Progression free survival
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
OS [ Time Frame: through study completion, an average of 18 months ] Overall survival
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Anlotinib Single Drug as the Maintenance Treatment for Advanced NSCLC | ||||
Official Title ICMJE | Study of Anlotinib Single Drug as the Maintenance Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) | ||||
Brief Summary | Based on the need of clinical practice of maintenance therapy for advanced NSCLC and the reliable data of third-line treatment for non-small cell lung cancer, the investigators designed a clinical study of anlotinib in maintenance therapy for advanced NSCLC to prospectively evaluate the efficacy of anlotinib in maintenance therapy for advanced NSCLC. Value, to provide a scientific basis for prolonging the survival time of patients with advanced NSCLC, improving the quality of life of patients in the course of treatment, and optimizing treatment strategies to a greater extent. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE | Non-Small Cell Lung Cancer | ||||
Intervention ICMJE | Drug: Anlotinib Hydrochloride
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.
|
||||
Study Arms ICMJE | Experimental: anlotinib
Intervention: Drug: Anlotinib Hydrochloride
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
40 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Routine blood test ANC≥1.5 x 109/L; PLT≥100 x 109/L; Hb≥90g/L Blood biochemistry TBIL≤1.5 x ULN ALT and AST≤2 x ULN; for patients with liver metastases, ALT and AST ≤5 x ULN; BUN and Cr≤1.5 x ULN and creatinine clearance≥50 ml/min;LVEF≥50%; 12 lead electrocardiogram The Fridericia-corrected QTcF was < 450 ms for males and < 470 MS for females.
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | |||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03998085 | ||||
Other Study ID Numbers ICMJE | K2018065 ALTER-L011 ( Other Identifier: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ) |
||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Responsible Party | The First Hospital of Jilin University | ||||
Study Sponsor ICMJE | The First Hospital of Jilin University | ||||
Collaborators ICMJE | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | The First Hospital of Jilin University | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |