Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0303）

Non-small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388919
• Other study ID #: ALTN-03-IIB
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 25, 2015
• Last updated: September 15, 2017
• Start date: February 26, 2015
• Est. completion date: January 6, 2017

Study information

• Verified date: January 2017
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the efficacy and safety of Anlotinib as the 3-line treatment of patients with advanced non-small lung cancer, with placebo control.

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 information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: January 6, 2017
• Est. primary completion date: January 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Anlotinib
Basic dosage, take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.
• Placebo
Basic dosage, take once when limosis in the morning.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Capital Medical University, Beijing Chest Hospital	Beijing	Beijing
China	Chinese Academy of Medical Sciences Cancer Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Jilin Province Tumor Hospital	Changchun	Jilin
China	Hunan Province Tumor Hospital	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital , Sichuan University	Chengdu	Sichuan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	Sichuan Cancer Hospital	Chongqing	Sichuan
China	Xinqiao Hospital	Chongqing	Chongqing
China	Fujian Province Tumor Hospital	Fuzhou	Fujian
China	First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Province Tumor Hospital	Hangzhou	Zhejiang
China	Harbin medical university affiliated tumor hospita	Harbin	Heilongjiang
China	Qilu Hospital,Shandong University	Jinan	Shandong
China	Shandong Province Tumor Hospital	Jinan	Shandong
China	Yunnan Province Tumor Hospital	Kunming	Yunnan
China	Gansu Province Tumor Hospital	Lanzhou	Gansu
China	Gansu Provincial People 's Hospital	Lanzhou	Gansu
China	Lanzhou Military General Hospital	Lanzhou	Gansu
China	Lianyungang First People 's Hospital	Lianyungang	Jiangsu
China	Linyi City Tumor Hospita	Linyi	Shandong
China	Henan Province Tumor Hospital	Luoyan	Henan
China	Jiangxi Province Tumor Hospital	Nanchang	Jiangxi
China	Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Cancer Hospital of Fudan University	Shanghai	Shanghai
China	Chest hospital affiliated to Shanghai jiaotong university	Shanghai	Shanghai
China	Shanghai Changhai Hospital	Shanghai	Shanghai
China	Xinhua hospital affiliated to Shanghai jiaotong university	Shanghai	Shanghai
China	First Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong
China	Liaoning Provincial Tumor Hospital	Shenyang	Liaoning
China	Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	First Affiliated Hospital of Xi'an Jiaotong University	Xian	Shanxi
China	Tang Du Hospital	Xian	Shanxi
China	Xuzhou Medical College Hospital	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		From randomization until death (up to 24 months)
Secondary	Progress free survival (PFS)		each 42 days up to PD or death(up to 24 months)
Secondary	Objective Response Rate (ORR)		each 42 days up to intolerance the toxicity or PD (up to 24 months)
Secondary	Disease Control Rate (DCR)		each 42 days up to intolerance the toxicity or PD (up to 24 months)
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Until 30 day safety follow-up visit

External Links

•   official website