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History of Changes for Study: NCT02388919
Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer(ALTER0303) (ALTER0303)
Latest version (submitted September 15, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 9, 2015 None (earliest Version on record)
2 January 11, 2016 Contacts/Locations and Study Status
3 September 18, 2016 Recruitment Status, Study Status and Contacts/Locations
4 January 10, 2017 Study Status
5 January 20, 2017 Recruitment Status, Study Status, Oversight, Study Design, IPDSharing and Study Description
6 September 15, 2017 Study Status and Oversight
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Study NCT02388919
Submitted Date:  March 9, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: ALTN-03-IIB
Brief Title: Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer(ALTER0303) (ALTER0303)
Official Title: A Registered Randomized, Double-Blind, Placebo-Controlled (2:1), Multi-Centered Clinical Trial of Anlotinib as a Treatment for Advanced Non-Small Cell Lung Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2015
Overall Status: Recruiting
Study Start: January 2015
Primary Completion: December 2016 [Anticipated]
Study Completion: May 2017 [Anticipated]
First Submitted: February 25, 2015
First Submitted that
Met QC Criteria:
March 9, 2015
First Posted: March 17, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 9, 2015
Last Update Posted: March 17, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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: Anlotibib (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.
Open or close this module Conditions
Conditions: Non-small Cell Lung Cancer
Keywords: anlotinib
Cancer
NSCLC
Non-small Cell Lung Cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 450 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Anlotinib
Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
Drug: Anlotinib
Basic dosage, take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.
Other Names:
  • AL3818
Placebo Comparator: Placebo
Placebo p.o, qd and it should be continued until disease progress or patients withdraw consent
Drug: Placebo
Basic dosage, take once when limosis in the morning.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall Survival (OS)
[ Time Frame: From randomization until death (up to 24 months) ]

Secondary Outcome Measures:
1. Progress free survival (PFS)
[ Time Frame: each 42 days up to PD or death(up to 24 months) ]

2. Objective Response Rate (ORR)
[ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]

3. Disease Control Rate (DCR)
[ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]

4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability
[ Time Frame: Until 30 day safety follow-up visit ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Signed and dated informed consent
  2. Diagnosed with advanced NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
  3. at least two systematic chemotherapy with upwards of 3-line treatments or cannot suffer
  4. 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
  5. ECOG PS:0-1,Expected Survival Time: Over 3 months
  6. main organs function is normal
  7. 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

Exclusion Criteria:

  1. have used Anlotinib before
  2. Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
  3. examined as positive in EGFR&ALK mutation detection and never take the treatment of TKIs
  4. central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
  5. other kinds of malignancies within 5 years or for now
  6. 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
  7. have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
  8. with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
  9. pleural effusion or ascites, resulting in respiratory syndrome (≥CTC AE level 2)
  10. symptoms of brain metastases cannot be controlled and treated within less than 2 months
  11. get any severe diseases or the ones that cannot be controlled
  12. take major surgical treatments, open biopsy, or get overt traumatic injury within 28 days before grouping
  13. 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)
  14. get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism
  15. ever abuse psychiatric drugs and cannot abstain or who are diagnosed with mental disorder
  16. have participated in other clinical trials of anti-tumor medicine within 4 weeks
  17. diagnosed with disease which will severely endanger the security of patients or influence the completion of this research.
Open or close this module Contacts/Locations
Central Contact Person: Baohui Han, professor
Email: xkyyhan@gmail.com
Study Officials: Baohui Han, professor
Study Director
Chest hospital affiliated to Shanghai jiaotong university
Kai Lee, professor
Study Director
Tianjin Medical University Cancer Hospital
Locations: China, Beijing
Beijing Friendship Hospital, Capital Medical University
[Not yet recruiting]
Beijing, Beijing, China
Contact:Contact: Bangwei Cao, Doctor
Capital Medical University, Beijing Chest Hospital
[Not yet recruiting]
Beijing, Beijing, China
Contact:Contact: Baolan Lee, Doctor
Chinese Academy of Medical Sciences Cancer Hospital
[Not yet recruiting]
Beijing, Beijing, China
Contact:Contact: Yuankai Shi, Doctor
Peking Union Medical College Hospital
[Not yet recruiting]
Beijing, Beijing, China
Contact:Contact: Li Zhang, Doctor
China, Chongqing
Chongqing Cancer Hospital
[Not yet recruiting]
Chongqing, Chongqing, China
Contact:Contact: Donglin Wang, Doctor
Xinqiao Hospital
[Not yet recruiting]
Chongqing, Chongqing, China
Contact:Contact: Guoming Wu, Doctor
China, Fujian
Fujian Province Tumor Hospital
[Not yet recruiting]
Fuzhou, Fujian, China
Contact:Contact: Cheng Huang, Doctor
China, Gansu
Gansu Province Tumor Hospital
[Not yet recruiting]
Lanzhou, Gansu, China
Contact:Contact: Lei Yang, Doctor
Gansu Provincial People 's Hospital
[Not yet recruiting]
Lanzhou, Gansu, China
Contact:Contact: Hu Liu, Doctor
Lanzhou Military General Hospital
[Not yet recruiting]
Lanzhou, Gansu, China
Contact:Contact: Baihong Zhang, Doctor
Contact:Contact: Weiqiang Chen, Doctor
China, Guangdong
First Affiliated Hospital of Guangzhou Medical University
[Not yet recruiting]
Guangzhou, Guangdong, China
Contact:Contact: Jianxing He, Doctor
First Affiliated Hospital of Shantou University Medical College
[Not yet recruiting]
Shantou, Guangdong, China
Contact:Contact: Liming Chen, Doctor
China, Hebei
Fourth Hospital of Hebei Medical University
[Not yet recruiting]
Shijiazhuang, Hebei, China
Contact:Contact: Cuiming Ding, Doctor
China, Heilongjiang
Harbin medical university affiliated tumor hospita
[Not yet recruiting]
Harbin, Heilongjiang, China
Contact:Contact: Yan Yu, Doctor
China, Henan
Henan Province Tumor Hospital
[Not yet recruiting]
Luoyan, Henan, China
Contact:Contact: Qiming Wang, Doctor
Contact:Contact: Zhiyong Ma, Doctor
China, Hunan
Hunan Province Tumor Hospital
[Not yet recruiting]
Changsha, Hunan, China
Contact:Contact: Lin Wu, Doctor
Contact:Contact: Yi Luo, Doctor
Xiangya Hospital Central South University
[Not yet recruiting]
Changsha, Hunan, China
Contact:Contact: Meizuo Zhong
China, Jiangsu
Lianyungang First People 's Hospital
[Not yet recruiting]
Lianyungang, Jiangsu, China
Contact:Contact: Xiaodong Jiang, Doctor
Xuzhou Medical College Hospital
[Not yet recruiting]
Xuzhou, Jiangsu, China
Contact:Contact: Hongbing Wang, Doctor
China, Jiangxi
Jiangxi Province Tumor Hospital
[Not yet recruiting]
Nanchang, Jiangxi, China
Contact:Contact: Yinlan Chen, Doctor
Second Affiliated Hospital of Nanchang University
[Not yet recruiting]
Nanchang, Jiangxi, China
Contact:Contact: Anwen Liu, Doctor
China, Jilin
Jilin Province Tumor Hospital
[Not yet recruiting]
Changchun, Jilin, China
Contact:Contact: Yin Cheng, Doctor
China, Liaoning
Liaoning Provincial Tumor Hospital
[Not yet recruiting]
Shenyang, Liaoning, China
Contact:Contact: Rui Ma, Doctor
China, Shandong
Qilu Hospital,Shandong University
[Not yet recruiting]
Jinan, Shandong, China
Contact:Contact: Xiuwen Wang, Doctor
Shandong Province Tumor Hospita
[Not yet recruiting]
Jinan, Shandong, China
Contact:Contact: Zhehai Wang, Doctor
Linyi City Tumor Hospita
[Not yet recruiting]
Linyi, Shandong, China
Contact:Contact: Jianhua Shi, Doctor
China, Shanghai
Chest hospital affiliated to Shanghai jiaotong university
[Recruiting]
Shanghai, Shanghai, China, 200000
Contact:Contact: Baohui Han, Professor xkyyhan@gmail.com
Cancer Hospital of Fudan University
[Not yet recruiting]
Shanghai, Shanghai, China
Contact:Contact: Jianhua Chang, Doctor
Shanghai Changhai Hospital
[Not yet recruiting]
Shanghai, Shanghai, China
Contact:Contact: Chong Bai, Doctor
Xinhua hospital affiliated to Shanghai jiaotong university
[Not yet recruiting]
Shanghai, Shanghai, China
Contact:Contact: Leizhen Zheng, Doctor
China, Shanxi
First Affiliated Hospital of Xi'an Jiaotong University
[Not yet recruiting]
Xian, Shanxi, China
Contact:Contact: Kejun Nan, Doctor
Tang Du Hospital
[Not yet recruiting]
Xian, Shanxi, China
Contact:Contact: Faguang Jin, Doctor
China, Sichuan
West China Hospital , Sichuan University
[Not yet recruiting]
Chengdu, Sichuan, China
Contact:Contact: Li Ren, Doctor
Sichuan Cancer Hospital
[Not yet recruiting]
Chongqing, Sichuan, China
Contact:Contact: Zhihui Zhang, Doctor
China, Tianjin
20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .
[Recruiting]
Tianjin, Tianjin, China, 300600
Contact:Contact: Li Kai, doctor likai5@medmail.com.cn
Contact:Principal Investigator: Li Kai, doctor
Tianjin Medical University General Hospital
[Not yet recruiting]
Tianjin, Tianjin, China
Contact:Contact: Jun Chen, Doctor
China, Yunnan
Yunnan Province Tumor Hospital
[Not yet recruiting]
Kunming, Yunnan, China
Contact:Contact: Jian Dong, Doctor
China, Zhejiang
The First Affiliated Hospital of Zhejiang University
[Not yet recruiting]
Hangzhou, Zhejiang, China
Contact:Contact: Jianying Zhou, Doctor
The Second Affiliated Hospital of Zhejiang University
[Not yet recruiting]
Hangzhou, Zhejiang, China
Contact:Contact: Jianjin Huang, Doctor
Zhejiang Province Tumor Hospital
[Not yet recruiting]
Hangzhou, Zhejiang, China
Contact:Contact: Yiping Zhang, Doctor
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: official website
Available IPD/Information:

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