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Lung CarcinomaPhase 2Spark-AL003NCT03709953

Efficacy and Safety of Apatinib as Third-line Therapy for Primary Pulmonary Lymphoepithelioid Carcinoma

A Phase 2 study testing Apatinib in people with Lung Carcinoma, run by Guangzhou Institute of Respiratory Disease at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Currently, there is no standard treatment for primary pulmonary lymphoepithelioid carcinoma. Apatinib is a new kind of Vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitors (TKIs). A disease-control rate of 75% was found in lung cancer patients in a phase II clinical study. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Carcinoma
What is being tested?
Apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
19 Oct 2018to 30 Apr 2021
Phase
Phase 2
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

  • patients aged from 18 to 75;
  • ECOG PS: 0 ~ 2 points;
  • lung lymphoepithelioid carcinoma;
  • Inoperable stage IV or stage III-B patients who had undergone second-line chemotherapy and had a measurable lesion (according to the RECIST 1.1 standard, the long diameter of the tumor lesion was 10mm in CT scan, the short diameter of the lymph node lesion was 15mm in CT scan, and the lesion was measured without local treatment such as radiotherapy and freezing).
  • Life expectancy ≥3 months;
  • the main organs are functioning normally:
Show all 12Show fewer
  • HB≥80 g/L(no blood transfusion within 14 days); ANC≥1.5×109 /L； PLT≥100×109 /L； WBC≥3×109 /L；
  • TBIL≤1.5×ULN (upper limit of normal value); ALT and AST ≤2.5×ULN；
  • creatinine ≤ 1.25 ULN; The clearance rate of creatinine ≥ 60mL/min.
  • 24-hour urinary protein quantification < 1.0g;
  • women of reproductive age (15 to 49 years old) must undergo a urinary pregnancy test within 7 days before starting treatment and the results must be negative. Women are willing to use appropriate methods of contraception;
  • Subjects signed the informed consent voluntarily.

Who cannot join

  • Histologically proved to be other types of lung cancer, patients with nasopharyngeal lymphatic epithelial carcinoma with lung metastasis should be excluded.
  • Imperfection of upper gastrointestinal physiology, or absorption disorder syndrome, or inability to tolerate oral drugs, or active peptic ulcer;
  • Participated in other clinical trials within 4 weeks before the start of the study;
  • patients with hypertension who cannot control well through single antihypertensive medication (systolic blood pressure > 140mmhg, diastolic blood pressure > 90mmhg), myocardial ischemia or myocardial infarction, arrhythmia (including QT interval > 440 ms) or cardiac insufficiency;
  • Allergic to any ingredient in the drug;
  • Patients with abnormal coagulation function, receiving thrombolysis or anticoagulation therapy, bleeding tendency or have clear gastrointestinal bleeding concerns;
Show all 17Show fewer
  • Hyperactive/venous thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism occurred in 6 months before the start of the study;
  • Wound or fracture has not been healed for a long time;
  • urinary protein was greater than ++ and 24-hour urinary protein quantification >1.0 g.
  • Severe or uncontrolled infections;
  • Substance abuse or mental disorder;
  • Objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, and severe impairment of pulmonary function;
  • Immunodeficiency, including being HIV-positive, or having other acquired, congenital immunodeficiency diseases, or having a history of organ transplantation;
  • Other malignant tumors within 5 years, except cured basal cell carcinoma of the skin and orthotopic carcinoma of the cervix;
  • Who have received VEGFR inhibitors, such as sorafenib and sunitinib, etc.;
  • pregnant or lactating women;
  • the researchers considered it unsuitable for inclusion.

Trial locations and contacts

1 site in 1 country.

Chengzhi Zhou, professor contact

13560351186

doctorzcz@163.com

China1 site, 1 recruiting

  • Zhou Chengzhi

    Guangzhou, Guangdong, 510120

    Chengzhi Zhou, Professor, 13560351186, doctorzcz@163.com

    Recruiting

Other trials in China

About this study

Currently, there is no standard treatment for primary pulmonary lymphoepithelioid carcinoma. Apatinib is a new kind of Vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitors (TKIs). A disease-control rate of 75% was found in lung cancer patients in a phase II clinical study. Therefore, researchers hope to explore the efficacy and safety of apatinib in the treatment of primary pulmonary lymphoepithelioid carcinoma.

Read the detailed description

This study is a prospective, exploratory clinical trial. The purpose of this study was to evaluate the efficacy and safety of apatinib monotherapy in the treatment of primary pulmonary lymphoepithelioid carcinoma.

Thirty-three cases of pulmonary lymphoepithelioid carcinoma were enrolled in this study.

The primary endpoint was median progression-free survival.

Conditions
Lung Carcinoma
Being tested
Apatinib
Keywords
apatinib, pulmonary lymphoepithelioid carcinoma
Medical subject headings
Lung Neoplasms

What participants receive

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

  • ApatinibDrug

    Also called Apatinib mesylate

    500 mg，po，QD； 28 days every cycle

Study groups in NCT03709953
Study groupRoleWhat they receive
apatinibExperimentalapatinib, 500 mg, po, QD; 28 days every cycle
Receives: Drug: Apatinib

What is being measured

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

  1. PFS

    Median progression-free survival

    Measured: 24 months

Secondary outcomes (3)

  1. OS

    Median overall survival

    Measured: 24 months

  2. ORR

    Objective Response Rate

    Measured: 24 months

  3. DCR

    Disease control rate

    Measured: 24 months

Timeline

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

  1. First posted17 Oct 2018
  2. Study start19 Oct 2018
  3. Primary completion31 Mar 2021 (estimated)
  4. Study completion30 Apr 2021 (estimated)

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
apatinib monotherapy
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03709953
Sponsor's protocol ID
Spark-AL003
Acronym
Spark-AL003
Status last verified
Oct 2018
First submitted
11 Oct 2018
Last updated
24 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Update after discussion

Publications

  • Begin LR, Eskandari J, Joncas J, Panasci L. Epstein-Barr virus related lymphoepithelioma-like carcinoma of lung. J Surg Oncol. 1987 Dec;36(4):280-3. doi: 10.1002/jso.2930360413.

    PubMed 2826922

  • Ngan RK, Yip TT, Cheng WW, Chan JK, Cho WC, Ma VW, Wan KK, Au JS, Law CK. Clinical role of circulating Epstein-Barr virus DNA as a tumor marker in lymphoepithelioma-like carcinoma of the lung. Ann N Y Acad Sci. 2004 Jun;1022:263-70. doi: 10.1196/annals.1318.041.

    PubMed 15251971

  • Lin L, Lin T, Zeng B. Primary lymphoepithelioma-like carcinoma of the lung: An unusual cancer and clinical outcomes of 14 patients. Oncol Lett. 2017 Sep;14(3):3110-3116. doi: 10.3892/ol.2017.6510. Epub 2017 Jun 30.

    PubMed 28928848

  • Kim C, Rajan A, DeBrito PA, Giaccone G. Metastatic lymphoepithelioma-like carcinoma of the lung treated with nivolumab: a case report and focused review of literature. Transl Lung Cancer Res. 2016 Dec;5(6):720-726. doi: 10.21037/tlcr.2016.11.06.

    PubMed 28149767

  • Khokhar N, Nasir H, Amir M, Hassan S, Khan K, Ahmed M. Lymphoepithelioma-Like Carcinoma of the Esophagus: A Rare Tumor. J Coll Physicians Surg Pak. 2017 Sep;27(9):S114-S116.

    PubMed 28969745

  • Lin CY, Chen YJ, Hsieh MH, Wang CW, Fang YF. Advanced primary pulmonary lymphoepithelioma-like carcinoma: clinical manifestations, treatment, and outcome. J Thorac Dis. 2017 Jan;9(1):123-128. doi: 10.21037/jtd.2017.01.25.

    PubMed 28203414

  • Ooi GC, Ho JC, Khong PL, Wong MP, Lam WK, Tsang KW. Computed tomography characteristics of advanced primary pulmonary lymphoepithelioma-like carcinoma. Eur Radiol. 2003 Mar;13(3):522-6. doi: 10.1007/s00330-002-1535-7. Epub 2002 Jul 16.

    PubMed 12594554

  • Mo Y, Shen J, Zhang Y, Zheng L, Gao F, Liu L, Xie C. Primary lymphoepithelioma-like carcinoma of the lung: distinct computed tomography features and associated clinical outcomes. J Thorac Imaging. 2014 Jul;29(4):246-51. doi: 10.1097/RTI.0000000000000070.

    PubMed 24463405

  • Ma H, Wu Y, Lin Y, Cai Q, Ma G, Liang Y. Computed tomography characteristics of primary pulmonary lymphoepithelioma-like carcinoma in 41 patients. Eur J Radiol. 2013 Aug;82(8):1343-6. doi: 10.1016/j.ejrad.2013.02.006. Epub 2013 Mar 5.

    PubMed 23465736

  • Tian S, Quan H, Xie C, Guo H, Lu F, Xu Y, Li J, Lou L. YN968D1 is a novel and selective inhibitor of vascular endothelial growth factor receptor-2 tyrosine kinase with potent activity in vitro and in vivo. Cancer Sci. 2011 Jul;102(7):1374-80. doi: 10.1111/j.1349-7006.2011.01939.x. Epub 2011 May 9.

    PubMed 21443688

  • Jeong JH, Nguyen HK, Lee JE, Suh W. Therapeutic effect of apatinib-loaded nanoparticles on diabetes-induced retinal vascular leakage. Int J Nanomedicine. 2016 Jul 7;11:3101-9. doi: 10.2147/IJN.S108452. eCollection 2016.

    PubMed 27462154

  • Mi YJ, Liang YJ, Huang HB, Zhao HY, Wu CP, Wang F, Tao LY, Zhang CZ, Dai CL, Tiwari AK, Ma XX, To KK, Ambudkar SV, Chen ZS, Fu LW. Apatinib (YN968D1) reverses multidrug resistance by inhibiting the efflux function of multiple ATP-binding cassette transporters. Cancer Res. 2010 Oct 15;70(20):7981-91. doi: 10.1158/0008-5472.CAN-10-0111. Epub 2010 Sep 28.

    PubMed 20876799

  • Tong XZ, Wang F, Liang S, Zhang X, He JH, Chen XG, Liang YJ, Mi YJ, To KK, Fu LW. Apatinib (YN968D1) enhances the efficacy of conventional chemotherapeutical drugs in side population cells and ABCB1-overexpressing leukemia cells. Biochem Pharmacol. 2012 Mar 1;83(5):586-97. doi: 10.1016/j.bcp.2011.12.007. Epub 2011 Dec 16.

    PubMed 22212563

  • Song Z, Yu X, Lou G, Shi X, Zhang Y. Salvage treatment with apatinib for advanced non-small-cell lung cancer. Onco Targets Ther. 2017 Mar 23;10:1821-1825. doi: 10.2147/OTT.S113435. eCollection 2017.

    PubMed 28367065

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib in people with Lung Carcinoma, run by Guangzhou Institute of Respiratory Disease at 1 site 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 12 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: status not confirmed, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Chengzhi Zhou, professor (13560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 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 NCT03709953, which also lists 14 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 24 Oct 2018.

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