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A Efficacy and Safety Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-line Treatment in Subjects With Advanced Non-squamous Cell Non-small Cell Lung Cancer

Primary Purpose

Advanced Non-squamous Cell Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Anlotinib hydrochloride capsule
Carboplatin injection
Pemetrexed disodium f Injection
Placebo
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-squamous Cell Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Local advanced (stage IIIB / ⅢC), metastatic or recurrent (stage IV) non-squamous cell non-small cell lung cancer, has at least one measurable lesion.

    2. EGFR, ALK, and ROS1 test results are negative. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.

    4. Has not received systemic anti-tumor treatment for advanced disease. 5.Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.

    7. Understood and signed an informed consent form.

Exclusion Criteria:

  • 1.Other histopathological types of non-small cell lung cancer. 2.Has received VEGF pathway targeted therapy including anlotinib and bevacizumab.

    3. Has multiple factors affecting oral medication. 4. Has symptomatic brain metastases. 5. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.

    6. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.

    7. Has any severe and / or uncontrolled diseases. 8. Has any bleeding symptoms or treated with anticoagulants or vitamin K antagonists.

    9.Has received surgery, or unhealed wounds within 4 weeks before the first administration.

    10. Has hemoptysis within 28 days before randomization. 11. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.

    12. Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis and pulmonary embolism.

    13. Has psychotropic substances abuse or a mental disorder. 14. Have a history of immunodeficiency. 15. Has received allogeneic organ transplantation, hematopoietic stem cell transplantation or bone marrow transplantation.

    16. Has other malignancy. 17.Has participated in other anticancer drug clinical trials within 4 weeks. 18.According to the judgement of the researchers, there are other factors that may lead to the termination of the study.

Sites / Locations

  • The Second Affiliated Hospital of Anhui Medical UniversityRecruiting
  • Anhui Chest HospitalRecruiting
  • Yijishan Hospital of Wannan Medical CollegeRecruiting
  • Beijing Chest Hospital, Capital Medical UniversityRecruiting
  • Peking University Third HospitalRecruiting
  • The Sixth Medical Center of Chinese PLA General HospitalRecruiting
  • Xuanwu Hospital of Capital Medical UniversityRecruiting
  • Chinese Academy of Medical Sciences, Peking Union Medical College HospitalRecruiting
  • The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • The Second Affiliated Hospital of Chinese PLA Army Medical UniversityRecruiting
  • Fujian Cancer HospitalRecruiting
  • The First Hospital of Lanzhou UniversityRecruiting
  • Gansu Wuwei Tumor HospitalRecruiting
  • The Fifth Affiliated Hospital of Sun Yat-sen UniversityRecruiting
  • The First Affiliated Hospital of Guangdong Pharmaceutical UniversityRecruiting
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityRecruiting
  • Meizhou People's HospitalRecruiting
  • Guangxi Medical University Affiliated Tumor HospitalRecruiting
  • The Fourth Hospital of Hebei Medical UniversityRecruiting
  • Xingtai People's HospitalRecruiting
  • Harbin Medical University Cancer HospitalRecruiting
  • First Affiliated Hospital of Henan University of Science and TechnologyRecruiting
  • The First Affiliated Hospital of Xinxiang Medical CollegeRecruiting
  • Henan Cancer HospitalRecruiting
  • Huazhong University of Science Tongji Hospital, Tongji Medical CollegeRecruiting
  • Xiangya Hospital Central South UniversityRecruiting
  • Hunan Cancer HospitalRecruiting
  • Changzhou Second People's HospitalRecruiting
  • Lianyungang First People's HospitalRecruiting
  • Affiliated Hospital of Nantong UniversityRecruiting
  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
  • Subei People's HospitalRecruiting
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • The Second Hospital of Jilin UniversityRecruiting
  • The Second Affiliated Hospital of Dalian Medical UniversityRecruiting
  • The First Affiliated Hospital of China Medical UniversityRecruiting
  • Liaoning Cancer HospitalRecruiting
  • The Affiliated Hospital of Inner Mongolia Medical UniversityRecruiting
  • Ningxia Medical University General HospitalRecruiting
  • Qilu Hospital of Shandong UniversityRecruiting
  • Affiliated Hospital of Jining Medical UniversityRecruiting
  • Linyi Cancer HospitalRecruiting
  • Tengzhou Central People's HospitalRecruiting
  • Fudan University Cancer HospitalRecruiting
  • Shanghai Chest HospitalRecruiting
  • Linfen Central HospitalRecruiting
  • The First Hospital of Shanxi Medical UniversityRecruiting
  • Tangdu Hospital, The Fourth Military Medical University of PLARecruiting
  • First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Dazhou Central HospitalRecruiting
  • Tianjin Chest HospitalRecruiting
  • Tianjin Medical University General HospitalRecruiting
  • Tianjin Cancer HospitalRecruiting
  • Affiliated Tumor Hospital of Xinjiang Medical UniversityRecruiting
  • Yunnan Cancer HospitalRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • The First Affiliated Hospital, College of Medicine, Zhejiang UniversityRecruiting
  • The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
  • Ruian People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anlotinib hydrochloride capsule + chemotherapy

Placebo + chemotherapy

Arm Description

Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) + Carboplatin injection (AUC 5mg/mL/min, intravenous drip, on Day 1) + Pemetrexed disodium f Injection (500mg / m2, intravenous drip, on Day 1).

Placebo given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) + Carboplatin injection (AUC 5mg/mL/min, intravenous drip, on Day 1) + Pemetrexed disodium f Injection (500mg / m2, intravenous drip, on Day 1).

Outcomes

Primary Outcome Measures

Progression free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

Secondary Outcome Measures

Overall response rate (ORR) assessed by Independent Review Committee (IRC)
Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Disease control rate（DCR）
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Disease of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

Full Information

First Posted
June 18, 2020
Last Updated
June 18, 2020
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04439890
Brief Title
A Efficacy and Safety Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-line Treatment in Subjects With Advanced Non-squamous Cell Non-small Cell Lung Cancer
Official Title
A Randomized, Double-blind, Multicenter Phase III Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-line Treatment in Subjects With Advanced Non-squamous Cell Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 8, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a randomized, double-blind, multicenter phase III clinical study to evaluate efficacy and safety of anlotinib hydrochloride capsule combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in subjects with advanced non-squamous cell non-small cell lung cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-squamous Cell Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
369 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anlotinib hydrochloride capsule + chemotherapy
Arm Type
Experimental
Arm Description
Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) + Carboplatin injection (AUC 5mg/mL/min, intravenous drip, on Day 1) + Pemetrexed disodium f Injection (500mg / m2, intravenous drip, on Day 1).
Arm Title
Placebo + chemotherapy
Arm Type
Placebo Comparator
Arm Description
Placebo given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) + Carboplatin injection (AUC 5mg/mL/min, intravenous drip, on Day 1) + Pemetrexed disodium f Injection (500mg / m2, intravenous drip, on Day 1).
Intervention Type
Drug
Intervention Name(s)
Anlotinib hydrochloride capsule
Intervention Description
Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
Intervention Type
Drug
Intervention Name(s)
Carboplatin injection
Intervention Description
Carboplatin injection AUC 5mg/mL/min, intravenous drip, on Day 1 in 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed disodium f Injection
Intervention Description
Pemetrexed disodium f Injection 500mg / m2, intravenous drip, on Day 1 in 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time Frame
up to 48 weeks
Secondary Outcome Measure Information:
Title
Overall response rate (ORR) assessed by Independent Review Committee (IRC)
Description
Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
Time Frame
up to 48 weeks
Title
Overall survival (OS)
Description
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Time Frame
up to 48 weeks
Title
Disease control rate（DCR）
Description
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time Frame
up to 48 weeks
Title
Disease of Response (DOR)
Description
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Time Frame
up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Local advanced (stage IIIB / ⅢC), metastatic or recurrent (stage IV) non-squamous cell non-small cell lung cancer, has at least one measurable lesion. 2. EGFR, ALK, and ROS1 test results are negative. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks. 4. Has not received systemic anti-tumor treatment for advanced disease. 5.Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization. 7. Understood and signed an informed consent form. Exclusion Criteria: 1.Other histopathological types of non-small cell lung cancer. 2.Has received VEGF pathway targeted therapy including anlotinib and bevacizumab. 3. Has multiple factors affecting oral medication. 4. Has symptomatic brain metastases. 5. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. 6. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1. 7. Has any severe and / or uncontrolled diseases. 8. Has any bleeding symptoms or treated with anticoagulants or vitamin K antagonists. 9.Has received surgery, or unhealed wounds within 4 weeks before the first administration. 10. Has hemoptysis within 28 days before randomization. 11. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear. 12. Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis and pulmonary embolism. 13. Has psychotropic substances abuse or a mental disorder. 14. Have a history of immunodeficiency. 15. Has received allogeneic organ transplantation, hematopoietic stem cell transplantation or bone marrow transplantation. 16. Has other malignancy. 17.Has participated in other anticancer drug clinical trials within 4 weeks. 18.According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
Facility Information:
Facility Name
The Second Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Zhao, Doctor
Email
dy61321157@163.com
First Name & Middle Initial & Last Name & Degree
Hui Zhao, Doctor
Facility Name
Anhui Chest Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuhong Min, Doctor
Email
13855179548‬@163.com
First Name & Middle Initial & Last Name & Degree
Xuhong Min, Doctor
Facility Name
Yijishan Hospital of Wannan Medical College
City
Wuhu
State/Province
Anhui
ZIP/Postal Code
242400
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiwei Lu, Doctor
Email
sduzhiwei@sina.com
First Name & Middle Initial & Last Name & Degree
Zhiwei Lu, Doctor
Facility Name
Beijing Chest Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baolan Li, Doctor
Email
libaolan1109@163.com
First Name & Middle Initial & Last Name & Degree
Baolan Li, Doctor
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baoshan Cao, Doctor
Email
caobaoshan0711@aliyun.com
First Name & Middle Initial & Last Name & Degree
Baoshan Cao, Doctor
Facility Name
The Sixth Medical Center of Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihai Han, Doctor
Email
hanzhihai@souhu.com
First Name & Middle Initial & Last Name & Degree
Zhihai Han, Doctor
Facility Name
Xuanwu Hospital of Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Zhang, Doctor
Email
steven9130@sina.com
First Name & Middle Initial & Last Name & Degree
Yi Zhang, Doctor
Facility Name
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhang, Doctor
Email
zhanglipumch@aliyun.com
First Name & Middle Initial & Last Name & Degree
Li Zhang, Doctor
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
431338
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Chen, Doctor
Email
417335669@qq.com
First Name & Middle Initial & Last Name & Degree
Hong Chen, Doctor
Facility Name
The Second Affiliated Hospital of Chinese PLA Army Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
431338
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi Xu, Doctor
Email
xu_zhi999@163.com
First Name & Middle Initial & Last Name & Degree
Zhi Xu, Doctor
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Zhuang, Doctor
Email
zhuangwu2008@126.com
First Name & Middle Initial & Last Name & Degree
Wu Zhuang, Doctor
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongmei Yue, Doctor
Email
13893265368@163.com
First Name & Middle Initial & Last Name & Degree
Hongmei Yue, Doctor
Facility Name
Gansu Wuwei Tumor Hospital
City
Wuwei
State/Province
Gansu
ZIP/Postal Code
733000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengguo Li, Doctor
Email
lizhengguo190@sina.com
First Name & Middle Initial & Last Name & Degree
Zhengguo Li, Doctor
Facility Name
The Fifth Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhong Lin, Doctor
Email
linzhong123@163.com
First Name & Middle Initial & Last Name & Degree
Zhong Lin, Doctor
Facility Name
The First Affiliated Hospital of Guangdong Pharmaceutical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Ding, Doctor
Email
dy61321157@163.com
First Name & Middle Initial & Last Name & Degree
Ying Ding, Doctor
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510289
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minhui Wang, Doctor
Email
wmingh@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Minhui Wang, Doctor
Facility Name
Meizhou People's Hospital
City
Meizhou
State/Province
Guangdong
ZIP/Postal Code
514798
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guowu Wu, Doctor
Email
wwwflay@126.com
First Name & Middle Initial & Last Name & Degree
Guowu Wu, Doctor
Facility Name
Guangxi Medical University Affiliated Tumor Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qitao Yu, Doctor
Email
yqt178@163.com
First Name & Middle Initial & Last Name & Degree
Qitao Yu, Doctor
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming He, Doctor
Email
heming6699@sina.com
First Name & Middle Initial & Last Name & Degree
Ming He, Doctor
Facility Name
Xingtai People's Hospital
City
Xingtai
State/Province
Hebei
ZIP/Postal Code
540000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Guo, Doctor
Email
guojun_868@sina.com
First Name & Middle Initial & Last Name & Degree
Jun Guo, Doctor
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Yu, Doctor
Email
gpyuyan@163.com
First Name & Middle Initial & Last Name & Degree
Yan Yu, Doctor
Facility Name
First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanzhen Guo, Doctor
Email
guoyanzhen177@163.com
First Name & Middle Initial & Last Name & Degree
Yanzhen Guo, Doctor
Facility Name
The First Affiliated Hospital of Xinxiang Medical College
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
455001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongrui Niu, Doctor
Email
1163458431@qq.com
First Name & Middle Initial & Last Name & Degree
Hongrui Niu, Doctor
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
475000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqiu Zhao, Doctor
Email
13938252350@163.com
First Name & Middle Initial & Last Name & Degree
Yanqiu Zhao, Doctor
Facility Name
Huazhong University of Science Tongji Hospital, Tongji Medical College
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Chen, Doctor
Email
18678766862@163.com
First Name & Middle Initial & Last Name & Degree
Yuan Chen, Doctor
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengping Hu, Doctor
Email
huchengp@126.com
First Name & Middle Initial & Last Name & Degree
Chengping Hu, Doctor
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
425001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Chen, Doctor
Email
cjh_1000@163.com
First Name & Middle Initial & Last Name & Degree
Jianhua Chen, Doctor
Facility Name
Changzhou Second People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingxia Yang, Doctor
Email
cougermx@126.com
First Name & Middle Initial & Last Name & Degree
Mingxia Yang, Doctor
Facility Name
Lianyungang First People's Hospital
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiashu Li, Doctor
Email
lissm1118@sina.com
First Name & Middle Initial & Last Name & Degree
Jiashu Li, Doctor
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226691
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Feng, Doctor
Email
jfeng68@126.com
First Name & Middle Initial & Last Name & Degree
Jian Feng, Doctor
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuping Du, Doctor
Email
1422363662@qq.com
First Name & Middle Initial & Last Name & Degree
Xiuping Du, Doctor
Facility Name
Subei People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
211400
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingxiang Xu, Doctor
Email
Xuxxu63@sina.com
First Name & Middle Initial & Last Name & Degree
Xingxiang Xu, Doctor
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Doctor
Email
13707089183@163.com
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Doctor
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yarong Li, Doctor
Email
Doctor.lyr@163.com
First Name & Middle Initial & Last Name & Degree
Yarong Li, Doctor
Facility Name
The Second Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Zhang, Doctor
Email
zydley@163.com
First Name & Middle Initial & Last Name & Degree
Yang Zhang, Doctor
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunpeng Liu, Doctor
Email
cmu_trial@163.com
First Name & Middle Initial & Last Name & Degree
Yunpeng Liu, Doctor
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weijun Bai, Doctor
Email
18900917878@163.com
First Name & Middle Initial & Last Name & Degree
Weijun Bai, Doctor
Facility Name
The Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
State/Province
Neimenggu
ZIP/Postal Code
010010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuhua Fu, Doctor
Email
1499521269@qq.com
First Name & Middle Initial & Last Name & Degree
Xiuhua Fu, Doctor
Facility Name
Ningxia Medical University General Hospital
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhou, Doctor
Email
zhw0306@126.com
First Name & Middle Initial & Last Name & Degree
Wei Zhou, Doctor
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuwen Wang, Doctor
Email
wangxiuwen@csco.org.cn
First Name & Middle Initial & Last Name & Degree
Xiuwen Wang, Doctor
Facility Name
Affiliated Hospital of Jining Medical University
City
Jining
State/Province
Shandong
ZIP/Postal Code
272000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shucheng Ye, Doctor
Email
18678766862@163.com
First Name & Middle Initial & Last Name & Degree
Shucheng Ye, Doctor
Facility Name
Linyi Cancer Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
277739
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Shi, Doctor
Email
lyzlyygcp@163.com
First Name & Middle Initial & Last Name & Degree
Jianhua Shi, Doctor
Facility Name
Tengzhou Central People's Hospital
City
Tengzhou
State/Province
Shandong
ZIP/Postal Code
277500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Li, Doctor
Email
lilingtz@163.com
First Name & Middle Initial & Last Name & Degree
Lin Li, Doctor
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jialei Wang, Doctor
Email
luwangjialei@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jialei Wang, Doctor
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baohui Han, Doctor
Phone
021-22200000-3138
First Name & Middle Initial & Last Name & Degree
Baohui Han, Doctor
Facility Name
Linfen Central Hospital
City
Linfen
State/Province
Shanxi
ZIP/Postal Code
314000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanli Li, Doctor
Email
1270005400@qq.com
First Name & Middle Initial & Last Name & Degree
Yanli Li, Doctor
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
300409
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shouan Ren, Doctor
Email
renshouan@163.com
First Name & Middle Initial & Last Name & Degree
Shouan Ren, Doctor
Facility Name
Tangdu Hospital, The Fourth Military Medical University of PLA
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Zhang, Doctor
Email
zhangft@fmmu.edu.com
First Name & Middle Initial & Last Name & Degree
Tao Zhang, Doctor
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
721001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manxiang Li, Doctor
Email
manxiangli@hotmail.com
First Name & Middle Initial & Last Name & Degree
Manxiang Li, Doctor
Facility Name
Dazhou Central Hospital
City
Dazhou
State/Province
Sichuan
ZIP/Postal Code
635000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fudao Wu, Doctor
Email
wfde@163.com
First Name & Middle Initial & Last Name & Degree
Fudao Wu, Doctor
Facility Name
Tianjin Chest Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xun Zhang, Doctor
Email
zhangxun69@163.com
First Name & Middle Initial & Last Name & Degree
Xun Zhang, Doctor
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diansheng Zhong, Doctor
Email
zhongdsh@hotmail.com
First Name & Middle Initial & Last Name & Degree
Diansheng Zhong, Doctor
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingzhi Huang, Doctor
Email
dingzhih72@163.com
First Name & Middle Initial & Last Name & Degree
Dingzhi Huang, Doctor
Facility Name
Affiliated Tumor Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigang Han, Doctor
Email
1378213986@qq.com
First Name & Middle Initial & Last Name & Degree
Zhigang Han, Doctor
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaofeng Li, Doctor
Email
ligaofenghl@126.com
First Name & Middle Initial & Last Name & Degree
Gaofeng Li, Doctor
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinmin Yu, Doctor
Email
yuxm@zjcc.org.cn
First Name & Middle Initial & Last Name & Degree
Xinmin Yu, Doctor
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianying Zhou, Doctor
Email
Drzjy@163.com
First Name & Middle Initial & Last Name & Degree
Jianying Zhou, Doctor
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Li, Doctor
Email
liwenzjhz0408@163.com
First Name & Middle Initial & Last Name & Degree
Wen Li, Doctor
Facility Name
Ruian People's Hospital
City
Ruian
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zongxiao Shangguan, Doctor
Email
sangxao0707@163.com
First Name & Middle Initial & Last Name & Degree
Zongxiao Shangguan, Doctor

12. IPD Sharing Statement

Learn more about this trial

A Efficacy and Safety Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-line Treatment in Subjects With Advanced Non-squamous Cell Non-small Cell Lung Cancer

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