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

NCT02388919 | Completed Phase 2 DMC

• 1 other identifier: ALTN-03-IIB
• Study Type: interventional
• Target: 439
• Locations: 1 country
• Sites: 40

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.

Conditions

Non-small Cell Lung Cancer

Keywords

anlotinib; Cancer; NSCLC; Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  From randomization until death (up to 24 months)

Secondary Outcomes (4)

• 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

Study Arms (2)

Anlotinib

EXPERIMENTAL

Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent

Drug: Anlotinib

Placebo

PLACEBO COMPARATOR

Placebo p.o, qd and it should be continued until disease progress or patients withdraw consent

Drug: Placebo

Interventions

Anlotinib DRUG

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

Also known as: AL3818

Anlotinib

Placebo DRUG

Basic dosage, take once when limosis in the morning.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (40)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Capital Medical University, Beijing Chest Hospital

Beijing, Beijing Municipality, China

Location

Chinese Academy of Medical Sciences Cancer Hospital

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Location

Xinqiao Hospital

Chongqing, Chongqing Municipality, China

Location

Fujian Province Tumor Hospital

Fuzhou, Fujian, China

Location

Gansu Province Tumor Hospital

Lanzhou, Gansu, China

Location

Gansu Provincial People 's Hospital

Lanzhou, Gansu, China

Location

Lanzhou Military General Hospital

Lanzhou, Gansu, China

Location

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Location

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Harbin medical university affiliated tumor hospita

Harbin, Heilongjiang, China

Location

Henan Province Tumor Hospital

Luoyan, Henan, China

Location

Hunan Province Tumor Hospital

Changsha, Hunan, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

Lianyungang First People 's Hospital

Lianyungang, Jiangsu, China

Location

Xuzhou Medical College Hospital

Xuzhou, Jiangsu, China

Location

Jiangxi Province Tumor Hospital

Nanchang, Jiangxi, China

Location

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Jilin Province Tumor Hospital

Changchun, Jilin, China

Location

Liaoning Provincial Tumor Hospital

Shenyang, Liaoning, China

Location

Qilu Hospital，Shandong University

Jinan, Shandong, China

Location

Shandong Province Tumor Hospital

Jinan, Shandong, China

Location

Linyi City Tumor Hospita

Linyi, Shandong, China

Location

Chest hospital affiliated to Shanghai jiaotong university

Shanghai, Shanghai Municipality, 200000, China

Location

Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Location

Xinhua hospital affiliated to Shanghai jiaotong university

Shanghai, Shanghai Municipality, China

Location

First Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, China

Location

Tang Du Hospital

Xian, Shanxi, China

Location

West China Hospital , Sichuan University

Chengdu, Sichuan, China

Location

Sichuan Cancer Hospital

Chongqing, Sichuan, China

Location

20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .

Tianjin, Tianjin Municipality, 300600, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

Yunnan Province Tumor Hospital

Kunming, Yunnan, China

Location

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Location

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Location

Zhejiang Province Tumor Hospital

Hangzhou, Zhejiang, China

Location

Related Publications (6)

• Qin T, Liu Z, Wang J, Xia J, Liu S, Jia Y, Liu H, Li K. Anlotinib suppresses lymphangiogenesis and lymphatic metastasis in lung adenocarcinoma through a process potentially involving VEGFR-3 signaling. Cancer Biol Med. 2020 Aug 15;17(3):753-767. doi: 10.20892/j.issn.2095-3941.2020.0024.

  PMID: 32944404 DERIVED

• Jiang S, Liang H, Liu Z, Zhao S, Liu J, Xie Z, Wang W, Zhang Y, Han B, He J, Liang W. The Impact of Anlotinib on Brain Metastases of Non-Small Cell Lung Cancer: Post Hoc Analysis of a Phase III Randomized Control Trial (ALTER0303). Oncologist. 2020 May;25(5):e870-e874. doi: 10.1634/theoncologist.2019-0838. Epub 2020 Feb 20.

  PMID: 32077550 DERIVED

• Zhang PL, Liu ZJ. Esophago-tracheobronchial fistula following treatment of anlotinib in advanced squamous cell lung cancer: Two case reports. Medicine (Baltimore). 2019 Nov;98(44):e17700. doi: 10.1097/MD.0000000000017700.

  PMID: 31689797 DERIVED

• Si XY, Wang HP, Zhang XT, Wang MZ, Zhang L. [Efficacy and safety of anlotinib in 16 patients with advanced non-small cell lung cancer]. Zhonghua Nei Ke Za Zhi. 2018 Nov 1;57(11):830-834. doi: 10.3760/cma.j.issn.0578-1426.2018.11.007. Chinese.

  PMID: 30392239 DERIVED

• Han B, Li K, Wang Q, Zhang L, Shi J, Wang Z, Cheng Y, He J, Shi Y, Zhao Y, Yu H, Zhao Y, Chen W, Luo Y, Wu L, Wang X, Pirker R, Nan K, Jin F, Dong J, Li B, Sun Y. Effect of Anlotinib as a Third-Line or Further Treatment on Overall Survival of Patients With Advanced Non-Small Cell Lung Cancer: The ALTER 0303 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2018 Nov 1;4(11):1569-1575. doi: 10.1001/jamaoncol.2018.3039.

  PMID: 30098152 DERIVED

• Si X, Zhang L, Wang H, Zhang X, Wang M, Han B, Li K, Wang Q, Shi J, Wang Z, Cheng Y, He J, Shi Y, Chen W, Wang X, Luo Y, Nan K, Jin F, Li B, Chen Y, Zhou J, Wang D. Quality of life results from a randomized, double-blinded, placebo-controlled, multi-center phase III trial of anlotinib in patients with advanced non-small cell lung cancer. Lung Cancer. 2018 Aug;122:32-37. doi: 10.1016/j.lungcan.2018.05.013. Epub 2018 May 18.

  PMID: 30032842 DERIVED

Related Links

• official website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Baohui Han, professor

  Chest hospital affiliated to Shanghai jiaotong university

  STUDY DIRECTOR

• Kai Lee, professor

  Tianjin Medical University Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 17, 2015
• Study Start: February 26, 2015
• Primary Completion: January 5, 2017
• Study Completion: January 6, 2017
• Last Updated: September 18, 2017

Record last verified: 2017-01

Locations

CN (40)