Phase II Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) as Third Line Treatment in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）

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 andvanced non-small cell lung cancer who failed two lines of chemotherapy

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Anlotinib; Drug: Placebo capsule

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    • Beijing, Beijing, China, 101149
      • Beijing Chest Hospital,Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China, 400037
      • Xinqiao Hospital, Third Military Medical University
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Province Tumor Hospital
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The first affiliated hospital of suzhou University
  • Jilin
    • Changchun, Jilin, China, 130000
      • Jilin Province Tumor Hospital
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Province Tumor Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Shanghai Changhai Hospital
    • Shanghai, Shanghai, China, 200000
      • Chest hospital affiliated to Shanghai jiaotong university
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital,Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital,Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. pathology diagnosed with advanced NSCL with measurable lesions;
2. Have failed for 2 lines of chemotherapy;
3. 18-70years,ECOG PS:0-2,Life expectancy of more than 3 months;
4. Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks;
5. main organs function is normal;
6. must be agreed to take contraceptive measures during the study and within 6 months after end.

Exclusion Criteria:

1. SCLC(including mixed with NSCLC);
2. the central cavity of Squamous cell carcinoma and hemoptysis with NSCLC;
3. patients failed to use the anti-tumor angiogenesis therapy;
4. patients has many influence factors toward oral medications ;
5. Brain metastases patients accompanied by symptoms or symptom control for less than two months;
6. patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)>10mmol/L);urine protein≥++,etc.
7. patients failed to heal wounds or fractures for Long-term;
8. 4 weeks before enrollment, patients appeared NCI CTC AE grading >1 pulmonary hemorrhage; 4 weeks before enrollment, patients who appeared NCI CTC AE grade> 2 have other parts of the bleeding; patients has a tendency to bleed (eg active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues;
9. patients occurred venous thromboembolic events within 6 months;
10. patients has HIV-positive or organ transplantation;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anlotinib; Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent	Drug: Anlotinib; Anlotinib QD po.
Placebo Comparator: Placebo Capsule; Placebo capsule QD po and it should be continued until disease progression or patients withdrawal of consent	Drug: Placebo capsule; Placebo QD po.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
enhanced CT/MRI scan	To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Refer to recist 1.1.	each 42 days up to disease progression

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	contain Serious Adverse Event To evaluate the safety of Anlotinib by CTC AE 4.0	each 21 days up to intolerance the toxicity(or PD)

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Investigators: Principal Investigator: Bao hui Han, doctor, Chest hospital affiliated to Shanghai jiaotong university

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 12, 2013
• First Submitted That Met QC Criteria: August 14, 2013
• First Posted (Estimate): August 16, 2013

Study Record Updates

• Last Update Posted (Estimate): October 28, 2015
• Last Update Submitted That Met QC Criteria: October 27, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Cancer; lung; NSCLC; Anlotinib; AL3818
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ALTN-03-II