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Non-small Cell Lung CancerPhase 2/3ALTER0303NCT02388919

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

A Phase 2/3 study testing Anlotinib in people with Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 40 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Anlotinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
439 participants
Where
40 sitesChina
Study dates
26 Feb 2015to 6 Jan 2017
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

China40 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Capital Medical University, Beijing Chest Hospital

    Beijing, Beijing Municipality

  • Chinese Academy of Medical Sciences Cancer Hospital

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Jilin Province Tumor Hospital

    Changchun, Jilin

  • Hunan Province Tumor Hospital

    Changsha, Hunan

  • Xiangya Hospital Central South University

    Changsha, Hunan

  • West China Hospital , Sichuan University

    Chengdu, Sichuan

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality

  • Xinqiao Hospital

    Chongqing, Chongqing Municipality

  • Sichuan Cancer Hospital

    Chongqing, Sichuan

  • Fujian Province Tumor Hospital

    Fuzhou, Fujian

  • First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang

  • Zhejiang Province Tumor Hospital

    Hangzhou, Zhejiang

  • Harbin medical university affiliated tumor hospita

    Harbin, Heilongjiang

  • Qilu Hospital，Shandong University

    Jinan, Shandong

  • Shandong Province Tumor Hospital

    Jinan, Shandong

  • Yunnan Province Tumor Hospital

    Kunming, Yunnan

  • Gansu Province Tumor Hospital

    Lanzhou, Gansu

  • Gansu Provincial People 's Hospital

    Lanzhou, Gansu

  • Lanzhou Military General Hospital

    Lanzhou, Gansu

  • Lianyungang First People 's Hospital

    Lianyungang, Jiangsu

  • Linyi City Tumor Hospita

    Linyi, Shandong

  • Henan Province Tumor Hospital

    Luoyan, Henan

  • Jiangxi Province Tumor Hospital

    Nanchang, Jiangxi

  • Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Chest hospital affiliated to Shanghai jiaotong university

    Shanghai, Shanghai Municipality, 200000

  • Cancer Hospital of Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality

  • Xinhua hospital affiliated to Shanghai jiaotong university

    Shanghai, Shanghai Municipality

  • First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong

  • Liaoning Provincial Tumor Hospital

    Shenyang, Liaoning

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

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

    Tianjin, Tianjin Municipality, 300600

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xian, Shanxi

  • Tang Du Hospital

    Xian, Shanxi

  • Xuzhou Medical College Hospital

    Xuzhou, Jiangsu

Other trials in China

About this study

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

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.

Being tested
Anlotinib, Placebo
Keywords
anlotinib, Cancer, NSCLC, Non-small Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnlotinibDrug

    Also called AL3818

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

  • PlaceboDrug

    Basic dosage, take once when limosis in the morning.

Study groups in NCT02388919
Study groupRoleWhat they receive
AnlotinibExperimentalAnlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
Receives: Drug: Anlotinib
PlaceboPlacebo comparatorPlacebo p.o, qd and it should be continued until disease progress or patients withdraw consent
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Measured: From randomization until death (up to 24 months)

Secondary outcomes (4)

  1. Progress free survival (PFS)

    Measured: each 42 days up to PD or death(up to 24 months)

  2. Objective Response Rate (ORR)

    Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)

  3. Disease Control Rate (DCR)

    Measured: 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

    Measured: Until 30 day safety follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2015 (estimated)
  2. Study start26 Feb 2015
  3. Primary completion5 Jan 2017
  4. Study completion6 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
439 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02388919
Sponsor's protocol ID
ALTN-03-IIB
Acronym
ALTER0303
Status last verified
Jan 2017
First submitted
25 Feb 2015
Last updated
18 Sep 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Anlotinib in people with Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 40 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From randomization until death (up to 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02388919, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.

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