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
- Conditions
- Advanced Non-squamous Cell Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT04439890
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 369
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Local advanced (stage IIIB / ⅢC), metastatic or recurrent (stage IV) non-squamous cell non-small cell lung cancer, has at least one measurable lesion.
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EGFR, ALK, and ROS1 test results are negative. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.
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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.
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Understood and signed an informed consent form.
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1.Other histopathological types of non-small cell lung cancer. 2.Has received VEGF pathway targeted therapy including anlotinib and bevacizumab.
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Has multiple factors affecting oral medication. 4. Has symptomatic brain metastases. 5. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
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Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
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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.
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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.
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Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis and pulmonary embolism.
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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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + chemotherapy Pemetrexed disodium f Injection 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). Placebo + chemotherapy Placebo 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). Placebo + chemotherapy Carboplatin injection 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). Anlotinib hydrochloride capsule + chemotherapy Carboplatin injection 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). Anlotinib hydrochloride capsule + chemotherapy 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) + Carboplatin injection (AUC 5mg/mL/min, intravenous drip, on Day 1) + Pemetrexed disodium f Injection (500mg / m2, intravenous drip, on Day 1). Anlotinib hydrochloride capsule + chemotherapy Pemetrexed disodium f Injection 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).
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) up to 48 weeks PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
- Secondary Outcome Measures
Name Time Method Disease control rate（DCR） up to 48 weeks Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Overall survival (OS) 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.
Disease of Response (DOR) up to 48 weeks DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Overall response rate (ORR) assessed by Independent Review Committee (IRC) up to 48 weeks Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
Trial Locations
- Locations (59)
Yijishan Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Anhui Chest Hospital
🇨🇳Hefei, Anhui, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
The Fifth Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Gansu Wuwei Tumor Hospital
🇨🇳Wuwei, Gansu, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Meizhou People's Hospital
🇨🇳Meizhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
🇨🇳Nanning, Guangxi, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Xingtai People's Hospital
🇨🇳Xingtai, Hebei, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical College
🇨🇳Xinxiang, Henan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Subei People's Hospital
🇨🇳Yangzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Second Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The First Affiliated Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Neimenggu, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Ningxia Medical University General Hospital
🇨🇳Yinchuan, Ningxia, China
Liaoning Cancer Hospital
🇨🇳Shenyang, Liaoning, China
Linyi Cancer Hospital
🇨🇳Linyi, Shandong, China
Tengzhou Central People's Hospital
🇨🇳Tengzhou, Shandong, China
The First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Tangdu Hospital, The Fourth Military Medical University of PLA
🇨🇳Xi'an, Shanxi, China
Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China
Tianjin Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Affiliated Tumor Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Dazhou Central Hospital
🇨🇳Dazhou, Sichuan, China
Tianjin Chest Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Ruian People's Hospital
🇨🇳Ruian, Zhejiang, China
Xuanwu Hospital of Capital Medical University
🇨🇳Beijing, Beijing, China
The Sixth Medical Center of Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Chest Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital of Chinese PLA Army Medical University
🇨🇳Chongqing, Chongqing, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Huazhong University of Science Tongji Hospital, Tongji Medical College
🇨🇳Wuhan, Hubei, China
Lianyungang First People's Hospital
🇨🇳Lianyungang, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Changzhou Second People's Hospital
🇨🇳Changzhou, Jiangsu, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
Affiliated Hospital of Jining Medical University
🇨🇳Jining, Shandong, China
Linfen Central Hospital
🇨🇳Linfen, Shanxi, China
First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China