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

June 18, 2020 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

369

Phase

  • 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
    • Anhui
      • Hefei, Anhui, China, 230001
        • Recruiting
        • The Second Affiliated Hospital of Anhui Medical University
        • Contact:
        • Principal Investigator:
          • Hui Zhao, Doctor
      • Hefei, Anhui, China, 230011
        • Recruiting
        • Anhui Chest Hospital
        • Contact:
        • Principal Investigator:
          • Xuhong Min, Doctor
      • Wuhu, Anhui, China, 242400
        • Recruiting
        • Yijishan Hospital of Wannan Medical College
        • Contact:
        • Principal Investigator:
          • Zhiwei Lu, Doctor
    • Beijing
      • Beijing, Beijing, China, 100010
        • Recruiting
        • Beijing Chest Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Baolan Li, Doctor
      • Beijing, Beijing, China, 100010
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Principal Investigator:
          • Baoshan Cao, Doctor
      • Beijing, Beijing, China, 100010
        • Recruiting
        • The Sixth Medical Center of Chinese PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Zhihai Han, Doctor
      • Beijing, Beijing, China, 100010
        • Recruiting
        • Xuanwu Hospital of Capital Medical University
        • Contact:
        • Principal Investigator:
          • Yi Zhang, Doctor
      • Beijing, Beijing, China, 100032
        • Recruiting
        • Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
        • Principal Investigator:
          • Li zhang, Doctor
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 431338
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
        • Principal Investigator:
          • Hong Chen, Doctor
      • Chongqing, Chongqing, China, 431338
        • Recruiting
        • The Second Affiliated Hospital of Chinese PLA Army Medical University
        • Contact:
        • Sub-Investigator:
          • Zhi Xu, Doctor
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Principal Investigator:
          • Wu Zhuang, Doctor
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
        • Principal Investigator:
          • Hongmei Yue, Doctor
      • Wuwei, Gansu, China, 733000
        • Recruiting
        • Gansu Wuwei Tumor Hospital
        • Contact:
        • Principal Investigator:
          • Zhengguo Li, Doctor
    • Guangdong
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • The Fifth Affiliated Hospital of Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Zhong Lin, Doctor
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
        • Contact:
        • Principal Investigator:
          • Ying Ding, Doctor
      • Guangzhou, Guangdong, China, 510289
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-Sen University
        • Contact:
        • Principal Investigator:
          • Minhui Wang, Doctor
      • Meizhou, Guangdong, China, 514798
        • Recruiting
        • Meizhou People's Hospital
        • Contact:
        • Principal Investigator:
          • Guowu Wu, Doctor
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
        • Contact:
        • Principal Investigator:
          • Qitao Yu, Doctor
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
        • Principal Investigator:
          • Ming He, Doctor
      • Xingtai, Hebei, China, 540000
        • Recruiting
        • Xingtai People's Hospital
        • Contact:
        • Principal Investigator:
          • Jun Guo, Doctor
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • Yan Yu, Doctor
    • Henan
      • Luoyang, Henan, China, 471000
        • Recruiting
        • First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Yanzhen Guo, Doctor
      • Xinxiang, Henan, China, 455001
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical College
        • Contact:
        • Principal Investigator:
          • Hongrui Niu, Doctor
      • Zhengzhou, Henan, China, 475000
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yanqiu Zhao, Doctor
    • Hubei
      • Wuhan, Hubei, China, 430010
        • Recruiting
        • Huazhong University of Science Tongji Hospital, Tongji Medical College
        • Principal Investigator:
          • Yuan Chen, Doctor
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
        • Principal Investigator:
          • Chengping Hu, Doctor
      • Changsha, Hunan, China, 425001
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jianhua Chen, Doctor
    • Jiangsu
      • Changzhou, Jiangsu, China, 213004
        • Recruiting
        • Changzhou Second People's Hospital
        • Contact:
        • Principal Investigator:
          • Mingxia Yang, Doctor
      • Lianyungang, Jiangsu, China, 222001
        • Recruiting
        • Lianyungang First People's Hospital
        • Contact:
        • Principal Investigator:
          • Jiashu Li, Doctor
      • Nantong, Jiangsu, China, 226691
        • Recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
        • Principal Investigator:
          • Jian Feng, Doctor
      • Xuzhou, Jiangsu, China, 221003
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
        • Principal Investigator:
          • Xiuping Du, Doctor
      • Yangzhou, Jiangsu, China, 211400
        • Recruiting
        • Subei People's Hospital
        • Contact:
        • Principal Investigator:
          • Xingxiang Xu, Doctor
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130011
        • Recruiting
        • The Second Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Yarong Li, Doctor
    • Liaoning
      • Dalian, Liaoning, China, 116001
        • Recruiting
        • The Second Affiliated Hospital of Dalian Medical University
        • Contact:
        • Principal Investigator:
          • Yang Zhang, Doctor
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The first affiliated hospital of China medical university
        • Contact:
        • Principal Investigator:
          • Yunpeng Liu, Doctor
      • Shenyang, Liaoning, China, 110042
        • Recruiting
        • Liaoning Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Weijun Bai, Doctor
    • Neimenggu
      • Hohhot, Neimenggu, China, 010010
        • Recruiting
        • The affiliated hospital of Inner Mongolia Medical University
        • Contact:
        • Principal Investigator:
          • Xiuhua Fu, Doctor
    • Ningxia
      • Yinchuan, Ningxia, China, 750001
        • Recruiting
        • Ningxia Medical University General Hospital
        • Contact:
        • Principal Investigator:
          • Wei Zhou, Doctor
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Principal Investigator:
          • Xiuwen Wang, Doctor
      • Jining, Shandong, China, 272000
        • Recruiting
        • Affiliated Hospital of Jining Medical University
        • Contact:
        • Principal Investigator:
          • Shucheng Ye, Doctor
      • Linyi, Shandong, China, 277739
        • Recruiting
        • Linyi Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jianhua Shi, Doctor
      • Tengzhou, Shandong, China, 277500
        • Recruiting
        • Tengzhou Central People's Hospital
        • Contact:
        • Principal Investigator:
          • Lin Li, Doctor
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jialei Wang, Doctor
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Chest Hospital
        • Principal Investigator:
          • Baohui Han, Doctor
        • Contact:
          • Baohui Han, Doctor
          • Phone Number: 021-22200000-3138
    • Shanxi
      • Linfen, Shanxi, China, 314000
        • Recruiting
        • Linfen Central Hospital
        • Contact:
        • Principal Investigator:
          • Yanli Li, Doctor
      • Taiyuan, Shanxi, China, 300409
        • Recruiting
        • The First Hospital of Shanxi Medical University
        • Contact:
        • Principal Investigator:
          • Shouan Ren, Doctor
      • Xi'an, Shanxi, China, 710038
        • Recruiting
        • Tangdu Hospital, The Fourth Military Medical University of PLA
        • Principal Investigator:
          • Tao Zhang, Doctor
        • Contact:
      • Xi'an, Shanxi, China, 721001
        • Recruiting
        • First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
        • Principal Investigator:
          • Manxiang Li, Doctor
    • Sichuan
      • Dazhou, Sichuan, China, 635000
        • Recruiting
        • Dazhou Central Hospital
        • Contact:
        • Principal Investigator:
          • Fudao Wu, Doctor
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Dingzhi Huang, Doctor
      • Tianjin, Tianjin, China, 300010
        • Recruiting
        • Tianjin Chest Hospital
        • Contact:
        • Principal Investigator:
          • Xun Zhang, Doctor
      • Tianjin, Tianjin, China, 300011
        • Recruiting
        • Tianjin Medical University General Hospital
        • Principal Investigator:
          • Diansheng Zhong, Doctor
        • Contact:
    • Xinjiang
      • Urumqi, Xinjiang, China, 830011
        • Recruiting
        • Affiliated Tumor Hospital of Xinjiang Medical University
        • Contact:
        • Principal Investigator:
          • Zhigang Han, Doctor
    • Yunnan
      • Kunming, Yunnan, China, 650011
        • Recruiting
        • Yunnan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Gaofeng Li, Doctor
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated hospital of Zhejiang University school of medicine
        • Contact:
        • Principal Investigator:
          • Wen Li, Doctor
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, College of Medicine, Zhejiang University
        • Principal Investigator:
          • Jianying Zhou, Doctor
        • Contact:
      • Hangzhou, Zhejiang, China, 310002
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Xinmin Yu, Doctor
      • Ruian, Zhejiang, China, 325000
        • Recruiting
        • Ruian People's Hospital
        • Contact:
        • Principal Investigator:
          • Zongxiao Shangguan, Doctor

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. 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.

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 hydrochloride capsule + chemotherapy
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).
Drug: Anlotinib hydrochloride capsule
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)
Drug: Carboplatin injection
Carboplatin injection AUC 5mg/mL/min, intravenous drip, on Day 1 in 21-day cycle.
Drug: Pemetrexed disodium f Injection
Pemetrexed disodium f Injection 500mg / m2, intravenous drip, on Day 1 in 21-day cycle.
Placebo Comparator: Placebo + chemotherapy
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).
Drug: Placebo
Placebo
Drug: Carboplatin injection
Carboplatin injection AUC 5mg/mL/min, intravenous drip, on Day 1 in 21-day cycle.
Drug: Pemetrexed disodium f Injection
Pemetrexed disodium f Injection 500mg / m2, intravenous drip, on Day 1 in 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: up to 48 weeks
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
up to 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: up to 48 weeks
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.
up to 48 weeks
Disease control rate（DCR）
Time Frame: up to 48 weeks
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
up to 48 weeks
Overall response rate (ORR) assessed by Independent Review Committee (IRC)
Time Frame: up to 48 weeks
Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
up to 48 weeks
Disease of Response (DOR)
Time Frame: up to 48 weeks
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
up to 48 weeks

Collaborators and Investigators

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

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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)

August 8, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

June 18, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTN-03-III-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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