Advanced Non-squamous Cell Non-small Cell Lung Cancer Clinical Trial
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
| Verified date | June 2020 |
| Source | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 369 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | June 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - 1. Local advanced (stage IIIB / ?C), 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Chest Hospital, Capital Medical University | Beijing | Beijing |
| China | Chinese Academy of Medical Sciences, Peking Union Medical College Hospital | Beijing | Beijing |
| China | Peking University Third Hospital | Beijing | Beijing |
| China | The Sixth Medical Center of Chinese PLA General Hospital | Beijing | Beijing |
| China | Xuanwu Hospital of Capital Medical University | Beijing | Beijing |
| China | The Second Hospital of Jilin University | Changchun | Jilin |
| China | Hunan Cancer Hospital | Changsha | Hunan |
| China | Xiangya Hospital Central South University | Changsha | Hunan |
| China | Changzhou Second People's Hospital | Changzhou | Jiangsu |
| China | The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
| China | The Second Affiliated Hospital of Chinese PLA Army Medical University | Chongqing | Chongqing |
| China | The Second Affiliated Hospital of Dalian Medical University | Dalian | Liaoning |
| China | Dazhou Central Hospital | Dazhou | Sichuan |
| China | Fujian Cancer Hospital | Fuzhou | Fujian |
| China | Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong |
| China | The Fifth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
| China | The First Affiliated Hospital of Guangdong Pharmaceutical University | Guangzhou | Guangdong |
| China | The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang |
| China | The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang |
| China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
| China | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang |
| China | Anhui Chest Hospital | Hefei | Anhui |
| China | The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
| China | The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Neimenggu |
| China | Qilu Hospital of Shandong University | Jinan | Shandong |
| China | Affiliated Hospital of Jining Medical University | Jining | Shandong |
| China | Yunnan Cancer Hospital | Kunming | Yunnan |
| China | The First Hospital of Lanzhou University | Lanzhou | Gansu |
| China | Lianyungang First People's Hospital | Lianyungang | Jiangsu |
| China | Linfen Central Hospital | Linfen | Shanxi |
| China | Linyi Cancer Hospital | Linyi | Shandong |
| China | First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan |
| China | Meizhou People's Hospital | Meizhou | Guangdong |
| China | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi |
| China | Guangxi Medical University Affiliated Tumor Hospital | Nanning | Guangxi |
| China | Affiliated Hospital of Nantong University | Nantong | Jiangsu |
| China | Ruian People's Hospital | Ruian | Zhejiang |
| China | Fudan University Cancer Hospital | Shanghai | Shanghai |
| China | Shanghai Chest Hospital | Shanghai | Shanghai |
| China | Liaoning Cancer Hospital | Shenyang | Liaoning |
| China | The First Affiliated Hospital of China Medical University | Shenyang | Liaoning |
| China | The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei |
| China | The First Hospital of Shanxi Medical University | Taiyuan | Shanxi |
| China | Tengzhou Central People's Hospital | Tengzhou | Shandong |
| China | Tianjin Cancer Hospital | Tianjin | Tianjin |
| China | Tianjin Chest Hospital | Tianjin | Tianjin |
| China | Tianjin Medical University General Hospital | Tianjin | Tianjin |
| China | Affiliated Tumor Hospital of Xinjiang Medical University | Urumqi | Xinjiang |
| China | Huazhong University of Science Tongji Hospital, Tongji Medical College | Wuhan | Hubei |
| China | Yijishan Hospital of Wannan Medical College | Wuhu | Anhui |
| China | Gansu Wuwei Tumor Hospital | Wuwei | Gansu |
| China | First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shanxi |
| China | Tangdu Hospital, The Fourth Military Medical University of PLA | Xi'an | Shanxi |
| China | Xingtai People's Hospital | Xingtai | Hebei |
| China | The First Affiliated Hospital of Xinxiang Medical College | Xinxiang | Henan |
| China | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu |
| China | Subei People's Hospital | Yangzhou | Jiangsu |
| China | Ningxia Medical University General Hospital | Yinchuan | Ningxia |
| China | Henan Cancer Hospital | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Overall response rate (ORR) assessed by Independent Review Committee (IRC) | Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC. | up to 48 weeks | |
| Secondary | 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. | up to 48 weeks | |
| Secondary | Disease control rate(DCR) | Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 48 weeks | |
| Secondary | Disease of Response (DOR) | DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment. | up to 48 weeks |