Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0303）
- Registration Number
- NCT02388919
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
Evaluate the efficacy and safety of Anlotinib as the 3-line treatment of patients with advanced non-small lung cancer, with placebo control.
- Detailed Description
Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 439
- Signed and dated informed consent
- Diagnosed with advanced NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
- at least two systematic chemotherapy with upwards of 3-line treatments or cannot suffer
- Patients must provide detectable specimen (from tumor tissue or hydrothorax) before participating, who negative in EGFR&ALK can participate or who positive in EGFR&ALK, have or have not drug tolerance after the treatment with relative targeted drugs
- ECOG PS：0-1,Expected Survival Time: Over 3 months
- main organs function is normal
- The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it
- have used Anlotinib before
- Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
- examined as positive in EGFR&ALK mutation detection and never take the treatment of TKIs
- central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
- other kinds of malignancies within 5 years or for now
- plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping
- have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
- with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
- pleural effusion or ascites, resulting in respiratory syndrome (≥CTC AE level 2)
- symptoms of brain metastases cannot be controlled and treated within less than 2 months
- get any severe diseases or the ones that cannot be controlled
- take major surgical treatments, open biopsy, or get overt traumatic injury within 28 days before grouping
- have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding (≥CTCAE level 3)
- get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism
- ever abuse psychiatric drugs and cannot abstain or who are diagnosed with mental disorder
- have participated in other clinical trials of anti-tumor medicine within 4 weeks
- diagnosed with disease which will severely endanger the security of patients or influence the completion of this research.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo p.o, qd and it should be continued until disease progress or patients withdraw consent Anlotinib Anlotinib Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
- Primary Outcome Measures
Name Time Method Overall Survival (OS) From randomization until death (up to 24 months)
- Secondary Outcome Measures
Name Time Method Progress free survival (PFS) each 42 days up to PD or death(up to 24 months) Objective Response Rate (ORR) each 42 days up to intolerance the toxicity or PD (up to 24 months) Disease Control Rate (DCR) each 42 days up to intolerance the toxicity or PD (up to 24 months) Number of Participants with Adverse Events as a Measure of Safety and Tolerability Until 30 day safety follow-up visit
Trial Locations
- Locations (40)
Xinqiao Hospital
🇨🇳Chongqing, Chongqing, China
Gansu Provincial People 's Hospital
🇨🇳Lanzhou, Gansu, China
First Affiliated Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
Jiangxi Province Tumor Hospital
🇨🇳Nanchang, Jiangxi, China
Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Second Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Sichuan Cancer Hospital
🇨🇳Chongqing, Sichuan, China
20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .
🇨🇳Tianjin, Tianjin, China
Yunnan Province Tumor Hospital
🇨🇳Kunming, Yunnan, China
Henan Province Tumor Hospital
🇨🇳Luoyan, Henan, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Liaoning Provincial Tumor Hospital
🇨🇳Shenyang, Liaoning, China
Capital Medical University, Beijing Chest Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Cancer Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Qilu Hospital，Shandong University
🇨🇳Jinan, Shandong, China
First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xian, Shanxi, China
Tang Du Hospital
🇨🇳Xian, Shanxi, China
The First Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Xinhua hospital affiliated to Shanghai jiaotong university
🇨🇳Shanghai, Shanghai, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Chinese Academy of Medical Sciences Cancer Hospital
🇨🇳Beijing, Beijing, China
Fujian Province Tumor Hospital
🇨🇳Fuzhou, Fujian, China
First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Harbin medical university affiliated tumor hospita
🇨🇳Harbin, Heilongjiang, China
Lanzhou Military General Hospital
🇨🇳Lanzhou, Gansu, China
Gansu Province Tumor Hospital
🇨🇳Lanzhou, Gansu, China
Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Lianyungang First People 's Hospital
🇨🇳Lianyungang, Jiangsu, China
Hunan Province Tumor Hospital
🇨🇳Changsha, Hunan, China
Xuzhou Medical College Hospital
🇨🇳Xuzhou, Jiangsu, China
Jilin Province Tumor Hospital
🇨🇳Changchun, Jilin, China
Chest hospital affiliated to Shanghai jiaotong university
🇨🇳Shanghai, Shanghai, China
Shandong Province Tumor Hospital
🇨🇳Jinan, Shandong, China
Shanghai Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Linyi City Tumor Hospita
🇨🇳Linyi, Shandong, China
West China Hospital , Sichuan University
🇨🇳Chengdu, Sichuan, China
Zhejiang Province Tumor Hospital
🇨🇳Hangzhou, Zhejiang, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China