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
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
1 other identifier
interventional
369
1 country
59
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2019
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 8, 2019
CompletedFirst Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
June 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJune 19, 2020
June 1, 2020
1.8 years
June 18, 2020
June 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
up to 48 weeks
Secondary Outcomes (4)
Overall response rate (ORR) assessed by Independent Review Committee (IRC)
up to 48 weeks
Overall survival (OS)
up to 48 weeks
Disease control rate（DCR）
up to 48 weeks
Disease of Response (DOR)
up to 48 weeks
Study Arms (2)
Anlotinib hydrochloride capsule + chemotherapy
EXPERIMENTALAnlotinib 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 + chemotherapy
PLACEBO COMPARATORPlacebo 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).
Interventions
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 in 21-day cycle.
Pemetrexed disodium f Injection 500mg / m2, intravenous drip, on Day 1 in 21-day cycle.
Eligibility Criteria
You may qualify if:
- \. Local advanced (stage IIIB / ⅢC), metastatic or recurrent (stage IV) non-squamous cell non-small cell lung cancer, has at least one measurable lesion.
- \. EGFR, ALK, and ROS1 test results are negative. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.
- \. 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.
- \. Understood and signed an informed consent form.
You may not qualify if:
- Other histopathological types of non-small cell lung cancer. 2.Has received VEGF pathway targeted therapy including anlotinib and bevacizumab.
- \. Has multiple factors affecting oral medication. 4. Has symptomatic brain metastases. 5. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- \. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
- \. Has any severe and / or uncontrolled diseases. 8. Has any bleeding symptoms or treated with anticoagulants or vitamin K antagonists.
- Has received surgery, or unhealed wounds within 4 weeks before the first administration.
- \. 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.
- \. Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis and pulmonary embolism.
- \. 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.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230001, China
Anhui Chest Hospital
Hefei, Anhui, 230011, China
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, 242400, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 100010, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100010, China
The Sixth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100010, China
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100010, China
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 431338, China
The Second Affiliated Hospital of Chinese PLA Army Medical University
Chongqing, Chongqing Municipality, 431338, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Gansu Wuwei Tumor Hospital
Wuwei, Gansu, 733000, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510010, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510010, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510289, China
Meizhou People's Hospital
Meizhou, Guangdong, 514798, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051, China
Xingtai People's Hospital
Xingtai, Hebei, 540000, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000, China
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, 455001, China
Henan Cancer Hospital
Zhengzhou, Henan, 475000, China
Huazhong University of Science Tongji Hospital, Tongji Medical College
Wuhan, Hubei, 430010, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Hunan Cancer Hospital
Changsha, Hunan, 425001, China
Changzhou Second People's Hospital
Changzhou, Jiangsu, 213004, China
Lianyungang First People's Hospital
Lianyungang, Jiangsu, 222001, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226691, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221003, China
Subei People's Hospital
Yangzhou, Jiangsu, 211400, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The Second Hospital of Jilin University
Changchun, Jilin, 130011, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116001, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Neimenggu, 010010, China
Ningxia Medical University General Hospital
Yinchuan, Ningxia, 750001, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272000, China
Linyi Cancer Hospital
Linyi, Shandong, 277739, China
Tengzhou Central People's Hospital
Tengzhou, Shandong, 277500, China
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Linfen Central Hospital
Linfen, Shanxi, 314000, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 300409, China
Tangdu Hospital, The Fourth Military Medical University of PLA
Xi’an, Shanxi, 710038, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 721001, China
Dazhou Central Hospital
Dazhou, Sichuan, 635000, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300010, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300011, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650011, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310002, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Ruian People's Hospital
Ruian, Zhejiang, 325000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2020
First Posted
June 19, 2020
Study Start
August 8, 2019
Primary Completion
June 1, 2021
Study Completion
December 31, 2021
Last Updated
June 19, 2020
Record last verified: 2020-06