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History of Changes for Study: NCT03589950
Anlotinib Plus Chemotherapy for Patients With Advanced Non-small Cell Lung Cancer
Latest version (submitted July 16, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 16, 2018 None (earliest Version on record)
Comparison Format:

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Study NCT03589950
Submitted Date:  July 16, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: Anlo01
Brief Title: Anlotinib Plus Chemotherapy for Patients With Advanced Non-small Cell Lung Cancer
Official Title: A Parallel Control, Exploratory Trial to Compare Anlotinib Plus Chemotherapy Versus Chemotherapy as Second-line Treatment in Subjects With Advanced Non-small Cell Lung Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2018
Overall Status: Unknown status [Previously: Not yet recruiting]
Study Start: August 1, 2018
Primary Completion: August 1, 2020 [Anticipated]
Study Completion: August 1, 2021 [Anticipated]
First Submitted: June 22, 2018
First Submitted that
Met QC Criteria:
July 16, 2018
First Posted: July 18, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
July 16, 2018
Last Update Posted: July 18, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: The First People's Hospital of Lianyungang
Responsible Party: Sponsor
Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration(SFDA:2011L00661) which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore Anlotinib for the effectiveness and safety of advanced non-small cell lung cancer who failed first lines of chemotherapy
Detailed Description:
Open or close this module Conditions
Conditions: Lung Neoplasms
Docetaxel
Pemetrexed
S-1
Anlotinib
Keywords: anlotinib
docetaxel
pemetrexed
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 60 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Anlotinib plus chemotherapy
Anlotinib (12mg QD PO d1-14, 21 days per cycle) + Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d/S-1 (80-120mg/day,depending on body surface area; days 1-28 in a 6-week cycle)
Drug: anlotinib plus chemotherapy
Anlotinib (12mg QD PO d1-14, 21 days per cycle), Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d/S-1 (80-120mg/day,depending on body surface area; days 1-28 in a 6-week cycle)
Active Comparator: Chemotherapy
Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d/S-1 (80-120mg/day,depending on body surface area; days 1-28 in a 6-week cycle)
Drug: chemotherapy
Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d/S-1 (80-120mg/day,depending on body surface area; days 1-28 in a 6-week cycle)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. PFS
[ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months ]

progression-free survival
2. DCR
[ Time Frame: Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]

Disease Control Rate
Secondary Outcome Measures:
1. OS
[ Time Frame: From randomization until death (up to 24 months) ]

Overall survival
2. ORR
[ Time Frame: each 21 days up to the toxicity or PD (up to 24 months) ]

Objective Response Rate
3. Quality of life score
[ Time Frame: each 21 days up to the toxicity or PD (up to 24 months) ]

Quality of life score
4. Safety
[ Time Frame: each 21 days up to the toxicity or PD (up to 24 months) ]

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Age:18~75 years;
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2
  3. Subjects with histologically or cytologically confirmed locally advanced or advanced NSCLC who have previously received one lines chemotherapy, EGFR TKI or ALK inhibitor (whom with EGFR or ALK mutation but not with T790 M positive) treatment before participating;
  4. Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which is confirmed by computed tomography (CT) scan or MRI .
  5. Subjects without brain metastases or asymptomatic brain metastases, and not needing for dehydrating agents or corticosteroids to control intracranial symptoms;
  6. Survival expectation ≥ 3 months;
  7. The main organ function is normal;
  8. Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative.
  9. Subjects provided written informed consent before participating, willing and able to comply with all aspects of the protocol

Exclusion Criteria:

1. Small Cell Lung Cancer; 2. Subjects with symptomatic brain metastases; 3. Survival expectation < 3 months; 4. examined as positive in EGFR&ALK mutation detection and never take the treatment of TKIs 5. Blood transfusion is required in the first dose of drug treatment within 14 days ; 6. The interval of subjects had received chemotherapy, biotherapy, radiotherapy or other anticancer therapies in the first dose of drug treatment within 21 days(excluding palliative radiotherapy); 7. The risk of active bleeding; 8. Subjects with uncontrolled blood pressure with medication (140/90 mmHg) 9. Laboratory values and organ functions : (1)Hematologic insufficiency:

  1. Hemoglobin (Hb)<8.5 g/dL,
  2. Absolute neutrophil count (ANC)≤1.5×109/L,
  3. Platelet count (PLT)< 100×109/L; (2)Insufficient liver function:
  4. Bilirubin > 1.5×the upper limit of normal (ULN)
  5. Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) >3.0×(ULN), When liver metastases,Bilirubin > 1.5×ULN, ALT or AST >5.0×(ULN.
  6. serum creatinine ≤1.0×(ULN), or creatinine clearance > 50 mL/min( calculated per the Cockcroft and Gault formula) (3) Subjects with positive for HBV surface antigen ( HBsAg)or anti-hcv (4)Subjects with Interstitial lung disease (5)Insufficient renal function: serum creatinine≥ 1.5×(ULN), or creatinine clearance <60 mL/min

10. impairment of heart function: (1)Left ventricular ejection fraction (LVEF) <45% (LVEF evaluation is not required for subjects have no history of congestive heart failure), (2)Unstable angina, (3)Severe arrhythmia, (4)NYHA III or IVgrade of congestive heart failure, (5) Subjects with myocardial infarction within the last 12 months before entering the trial, (6)Pericardial effusion, 11. Subjects with liver fibrosis or hepatic cirrhosis 12. (1)Subjects with other active malignancy (except for definitively treated non melanoma skin cancer,carcinoma in-situ of the cervix,or other cancers that are treated with curative treatment and have no signs of recurrence for at least 5 years ) , (2)Subjects with dysphagia,malabsorption,chronic gastrointestinal diseases,or other medical history may hinder compliance and / or experimental drug absorption, 13. Subjects with major surgery in the first dose of drug treatment within 28 days, 14. Subjects with positive unknown human immunodeficiency virus.

Open or close this module Contacts/Locations
Locations: China, Jiangsu
The Affiliated Lianyungang Hospital of Xuzhou Medical University
Lianyungang, Jiangsu, China, 222002
Contact:Contact: xiaodong jiang, MD 18961326201 jxdysy1970@163.com
Contact:Sub-Investigator: lijun liang, MM
Contact:Sub-Investigator: yixuan wen, MM
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Xie C, Wan X, Quan H, Zheng M, Fu L, Li Y, Lou L. Preclinical characterization of anlotinib, a highly potent and selective vascular endothelial growth factor receptor-2 inhibitor. Cancer Sci. 2018 Apr;109(4):1207-1219. doi: 10.1111/cas.13536. Epub 2018 Mar 25. PubMed 29446853
Sun Y, Niu W, Du F, Du C, Li S, Wang J, Li L, Wang F, Hao Y, Li C, Chi Y. Safety, pharmacokinetics, and antitumor properties of anlotinib, an oral multi-target tyrosine kinase inhibitor, in patients with advanced refractory solid tumors. J Hematol Oncol. 2016 Oct 4;9(1):105. PubMed 27716285
Han B, Li K, Zhao Y, Li B, Cheng Y, Zhou J, Lu Y, Shi Y, Wang Z, Jiang L, Luo Y, Zhang Y, Huang C, Li Q, Wu G. Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302). Br J Cancer. 2018 Mar 6;118(5):654-661. doi: 10.1038/bjc.2017.478. Epub 2018 Feb 13. PubMed 29438373
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