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CompletedNCT02388919ALTER0303Updated Sep 18, 2017

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

A Phase 2/3 interventional study of Anlotinib and Placebo in Non-small Cell Lung Cancer, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Completed at 40 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-09-18.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
439
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Non-small Cell Lung Cancer

Keywords

  • anlotinib
  • Cancer
  • NSCLC
  • Non-small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 439 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
439 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugAnlotinib

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

    Also known as: AL3818

  • DrugPlacebo

    Basic dosage, take once when limosis in the morning.

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS)

    Time frame: From randomization until death (up to 24 months)

Secondary outcomes

  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

07

Study locations

40 sites
  • 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
  • Chongqing Cancer Hospital
    Chongqing, Chongqing, China
  • Xinqiao Hospital
    Chongqing, Chongqing, China
  • Fujian Province Tumor Hospital
    Fuzhou, Fujian, China
  • Gansu Province Tumor Hospital
    Lanzhou, Gansu, China
  • Gansu Provincial People 's Hospital
    Lanzhou, Gansu, China
  • Lanzhou Military General Hospital
    Lanzhou, Gansu, China
  • First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong, China
  • First Affiliated Hospital of Shantou University Medical College
    Shantou, Guangdong, China
  • Fourth Hospital of Hebei Medical University
    Shijiazhuang, Hebei, China
  • Harbin medical university affiliated tumor hospita
    Harbin, Heilongjiang, China
  • Henan Province Tumor Hospital
    Luoyan, Henan, China
  • Hunan Province Tumor Hospital
    Changsha, Hunan, China
  • Xiangya Hospital Central South University
    Changsha, Hunan, China
  • Lianyungang First People 's Hospital
    Lianyungang, Jiangsu, China
  • Xuzhou Medical College Hospital
    Xuzhou, Jiangsu, China
  • Jiangxi Province Tumor Hospital
    Nanchang, Jiangxi, China
  • Second Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi, China
  • Jilin Province Tumor Hospital
    Changchun, Jilin, China
  • Liaoning Provincial Tumor Hospital
    Shenyang, Liaoning, China
  • Qilu Hospital，Shandong University
    Jinan, Shandong, China
  • Shandong Province Tumor Hospital
    Jinan, Shandong, China
  • Linyi City Tumor Hospita
    Linyi, Shandong, China
  • Chest hospital affiliated to Shanghai jiaotong university
    Shanghai, Shanghai 200000, China
  • Cancer Hospital of Fudan University
    Shanghai, Shanghai, China
  • Shanghai Changhai Hospital
    Shanghai, Shanghai, China
  • Xinhua hospital affiliated to Shanghai jiaotong university
    Shanghai, Shanghai, China
  • First Affiliated Hospital of Xi'an Jiaotong University
    Xian, Shanxi, China
  • Tang Du Hospital
    Xian, Shanxi, China
  • West China Hospital , Sichuan University
    Chengdu, Sichuan, China
  • Sichuan Cancer Hospital
    Chongqing, Sichuan, China
  • 20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .
    Tianjin, Tianjin 300600, China
  • Tianjin Medical University General Hospital
    Tianjin, Tianjin, China
  • Yunnan Province Tumor Hospital
    Kunming, Yunnan, 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
08

References and documents

Publications

  • 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. PubMed 32944404 ↗
  • 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. PubMed 32077550 ↗
  • 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. PubMed 31689797 ↗
  • 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. PubMed 30392239 ↗
  • 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. Erratum In: JAMA Oncol. 2018 Nov 1;4(11):1625. doi: 10.1001/jamaoncol.2018.5345. PubMed 30098152 ↗
  • 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. PubMed 30032842 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02388919
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Mar 17, 2015
Start date
Feb 26, 2015
Primary completion
Jan 5, 2017
Completion
Jan 6, 2017
Last update
Sep 18, 2017

Study contacts

Baohui Han, professor
study director · Chest hospital affiliated to Shanghai jiaotong university
Kai Lee, professor
study director · Tianjin Medical University Cancer Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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