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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
439

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 6, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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