Anlotinib Plus Chemotherapy for Patients With Advanced Non-small Cell Lung Cancer

NCT03589950 | Unknown Phase 2 DMC

• 1 other identifier: Anlo01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Neoplasms; Docetaxel; Pemetrexed; S-1; Anlotinib

Keywords

anlotinib; docetaxel; pemetrexed

Outcome Measures

Primary Outcomes (2)

• PFS

  progression-free survival

  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

• DCR

  Disease Control Rate

  Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)

Secondary Outcomes (4)

• OS

  From randomization until death (up to 24 months)

• ORR

  each 21 days up to the toxicity or PD (up to 24 months)

• Quality of life score

  each 21 days up to the toxicity or PD (up to 24 months)

• Safety

  each 21 days up to the toxicity or PD (up to 24 months)

Study Arms (2)

Anlotinib plus chemotherapy

EXPERIMENTAL

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

Chemotherapy

ACTIVE COMPARATOR

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

Interventions

anlotinib plus chemotherapy DRUG

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)

Anlotinib plus chemotherapy

chemotherapy DRUG

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)

Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age：18\~75 years;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2
• 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；
• Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which is confirmed by computed tomography (CT) scan or MRI .
• Subjects without brain metastases or asymptomatic brain metastases, and not needing for dehydrating agents or corticosteroids to control intracranial symptoms;
• Survival expectation ≥ 3 months;
• The main organ function is normal;
• Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative.
• Subjects provided written informed consent before participating, willing and able to comply with all aspects of the protocol

You may not qualify if:

• \. 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:
• Hemoglobin (Hb)\<8.5 g/dL，
• Absolute neutrophil count (ANC)≤1.5×109/L，
• Platelet count (PLT)\< 100×109/L； （2）Insufficient liver function:
• Bilirubin \> 1.5×the upper limit of normal (ULN)
• Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) \>3.0×(ULN), When liver metastases,Bilirubin \> 1.5×ULN, ALT or AST \>5.0×(ULN.
• 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
• \. 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.

Sponsors & Collaborators

• The First People's Hospital of Lianyungang: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

The Affiliated Lianyungang Hospital of Xuzhou Medical University

Lianyungang, Jiangsu, 222002, China

Location

Related Publications (3)

• 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.

  PMID: 29446853 BACKGROUND

• 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. doi: 10.1186/s13045-016-0332-8.

  PMID: 27716285 BACKGROUND

• 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.

  PMID: 29438373 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

anlotinib; Drug Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

xiaodong jiang, MD

CONTACT

18961326201; jxdysy1970@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 18, 2018
• Study Start: August 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2021
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

CN (1)