Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0303） (ALTER0303)

September 15, 2017 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Registered Randomized, Double-Blind, Placebo-Controlled (2:1), Multi-Centered Clinical Trial of Anlotinib as a Treatment for Advanced Non-Small Cell Lung Cancer

Evaluate the efficacy and safety of Anlotinib as the 3-line treatment of patients with advanced non-small lung cancer, with placebo control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anlotinib (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 VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.

Study Type

Interventional

Enrollment (Actual)

439

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China
        • Beijing Friendship Hospital, Capital Medical University
      • Beijing, Beijing, China
        • Capital Medical University, Beijing Chest Hospital
      • Beijing, Beijing, China
        • Chinese Academy of Medical Sciences Cancer Hospital
    • Chongqing
      • Chongqing, Chongqing, China
        • Chongqing Cancer Hospital
      • Chongqing, Chongqing, China
        • Xinqiao Hospital
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Province Tumor Hospital
    • Gansu
      • Lanzhou, Gansu, China
        • Gansu Province Tumor Hospital
      • Lanzhou, Gansu, China
        • Gansu Provincial People 's Hospital
      • Lanzhou, Gansu, China
        • Lanzhou Military General Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • First Affiliated Hospital of Guangzhou Medical University
      • Shantou, Guangdong, China
        • First Affiliated Hospital of Shantou University Medical College
    • Hebei
      • Shijiazhuang, Hebei, China
        • Fourth Hospital of Hebei Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Harbin medical university affiliated tumor hospita
    • Henan
      • Luoyan, Henan, China
        • Henan Province Tumor Hospital
    • Hunan
      • Changsha, Hunan, China
        • Hunan Province Tumor Hospital
      • Changsha, Hunan, China
        • Xiangya Hospital Central South University
    • Jiangsu
      • Lianyungang, Jiangsu, China
        • Lianyungang First People 's Hospital
      • Xuzhou, Jiangsu, China
        • Xuzhou Medical College Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • JiangXi Province Tumor Hospital
      • Nanchang, Jiangxi, China
        • Second Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China
        • Jilin Province Tumor Hospital
    • Liaoning
      • Shenyang, Liaoning, China
        • Liaoning Provincial Tumor Hospital
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital，Shandong University
      • Jinan, Shandong, China
        • Shandong Province Tumor Hospital
      • Linyi, Shandong, China
        • Linyi City Tumor Hospita
    • Shanghai
      • Shanghai, Shanghai, China
        • Xinhua Hospital Affiliated to Shanghai Jiaotong University
      • Shanghai, Shanghai, China, 200000
        • Chest hospital affiliated to Shanghai jiaotong university
      • Shanghai, Shanghai, China
        • Cancer Hospital of Fudan University
      • Shanghai, Shanghai, China
        • Shanghai Changhai Hospital
    • Shanxi
      • Xian, Shanxi, China
        • First Affiliated Hospital of Xi'an Jiaotong University
      • Xian, Shanxi, China
        • Tang Du Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital , Sichuan University
      • Chongqing, Sichuan, China
        • Sichuan Cancer Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300600
        • 20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .
      • Tianjin, Tianjin, China
        • Tianjin Medical University General Hospital
    • Yunnan
      • Kunming, Yunnan, China
        • Yunnan Province Tumor Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The Second Affiliated Hospital of Zhejiang University
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital of Zhejiang University
      • Hangzhou, Zhejiang, China
        • Zhejiang Province Tumor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed and dated informed consent
  2. Diagnosed with advanced NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
  3. at least two systematic chemotherapy with upwards of 3-line treatments or cannot suffer
  4. Patients must provide detectable specimen (from tumor tissue or hydrothorax) before participating, who negative in EGFR&ALK can participate or who positive in EGFR&ALK, have or have not drug tolerance after the treatment with relative targeted drugs
  5. ECOG PS：0-1,Expected Survival Time: Over 3 months
  6. main organs function is normal
  7. The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it

Exclusion Criteria:

  1. have used Anlotinib before
  2. Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
  3. examined as positive in EGFR&ALK mutation detection and never take the treatment of TKIs
  4. central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
  5. other kinds of malignancies within 5 years or for now
  6. plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping
  7. have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
  8. with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
  9. pleural effusion or ascites, resulting in respiratory syndrome (≥CTC AE level 2)
  10. symptoms of brain metastases cannot be controlled and treated within less than 2 months
  11. get any severe diseases or the ones that cannot be controlled
  12. take major surgical treatments, open biopsy, or get overt traumatic injury within 28 days before grouping
  13. have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding (≥CTCAE level 3)
  14. get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism
  15. ever abuse psychiatric drugs and cannot abstain or who are diagnosed with mental disorder
  16. have participated in other clinical trials of anti-tumor medicine within 4 weeks
  17. diagnosed with disease which will severely endanger the security of patients or influence the completion of this research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anlotinib
Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
Drug: Anlotinib
Basic dosage, take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.
Other Names:
  • AL3818
Placebo Comparator: Placebo
Placebo p.o, qd and it should be continued until disease progress or patients withdraw consent
Drug: Placebo
Basic dosage, take once when limosis in the morning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: From randomization until death (up to 24 months)
From randomization until death (up to 24 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Progress free survival (PFS)
Time Frame: each 42 days up to PD or death(up to 24 months)
each 42 days up to PD or death(up to 24 months)
Objective Response Rate (ORR)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Until 30 day safety follow-up visit
Until 30 day safety follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

  • Study Director: Baohui Han, professor, Chest hospital affiliated to Shanghai jiaotong university
  • Study Director: Kai Lee, professor, Tianjin Medical University Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2015

Primary Completion (Actual)

January 5, 2017

Study Completion (Actual)

January 6, 2017

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 15, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTN-03-IIB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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