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
Advanced Non-squamous Cell Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Advanced Non-squamous Cell Non-small Cell Lung Cancer
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.
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
Experimental
Placebo Comparator
Anlotinib hydrochloride capsule + chemotherapy
Placebo + 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).
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).