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Status unknownNCT03376191Updated Dec 18, 2017

Apatinib in Advanced Non-squamous，NSCLC

An observational study in Non-squamous Non-Small Cell Lung Cancer, sponsored by Jian Fang. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-18.

Sponsored by Jian Fang · Observational

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

To explore the efficacy and safety of apatinib in non-squamous non-small cell lung cancer in the real-world.

Read the detailed description

This is a multi-center, non-interventional clinical study. The number of patients that planned to be recruited is: from May 2017 to April 2019, the actual number of cases recruited into this study.

If the clinicians thought the patient is suitable to take apatinib treatment, and give the patient apatinib treatment, the patient can be recruited into this study. Clinicians chose the initial dose of apatinib according to the patient's physical condition. Besides the clinicians adjusted the dose according to the patient's tolerance during the medication. The dosage was demanded not higher than 750 milligram (mg) per day. The patients received apatinib continuously, 28 days for a period, until intolerance, no longer getting benefits or patient wanted stop.

During the course of the study, the researchers will not intervene the treatment of the patients, but only record the efficacy and adverse reactions.

Main evaluation criteria: PFS Secondary evaluation criteria: OS,DCR and ORR (according to RECIST1.1). Main safety indicators：AE, SAE (according to NCI CTCAE V4.0) and QOL scores (Quality of Life Questionnaire-lung cancer).

02

Conditions studied

  • Non-squamous Non-Small Cell Lung Cancer

Keywords

  • Apatinib
  • lung cancer
  • angiogenesis inhibitors
  • efficacy
  • safety
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Local advanced or advanced non-squamous non-small cell lung cancer patients

Inclusion criteria

  1. Age: ≥ 18 years old;
  2. Histologically or cytologically confirmed, locally advanced or stage IV non-squamous, non-small cell lung cancer;
  3. Regardless of the past anti-tumor treatments (no limited to the number of past treatment lines), the doctors believe that apatinib can bring benefits to patients;
  4. The patient is voluntarily to join the study, and signed informed consent, good compliance, with follow-up.

Exclusion criteria

Exclusion Criteria:

If any of the following criteria is met, the subject shall be excluded:

  1. Squamous cell carcinoma and/or small cell lung cancer patients;
  2. There are contraindications to apatinib (active bleeding, thrombosis, ulcers, intestinal perforation, intestinal obstruction, uncontrollable hypertension, grade III-IV cardiac insufficiency, major surgery within 30 days, severe liver and kidney dysfunction, etc.);
  3. Allergic to apatinib and / or its excipients;
  4. Pregnant or lactating women;
  5. According to the researcher's judgment, there are other situations that may increase the risk associated with participating in this study or the drug, which may lead to patients not being eligible for enrollment in the study.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Drugapatinib

    Clinicians chose the initial dose of apatinib according to the patient's physical condition. Besides the clinicians adjusted the dose according to the patient's tolerance during the medication.The dosage was demanded not higher than 750 milligram (mg) per day. The patients received apatinib continuously, 28 days for a period, until intolerance, no longer getting benefits or patient wanted stop.

05

What researchers measure

Primary outcomes

  1. PFS (Progression-Free survival)

    From the date Into this study (signed ICF) to tumor progression or death for any reason.

    Time frame: From the date Into this study (signed ICF) to tumor progression or death for any reason，whichever came first, assessed up to 36 months

Secondary outcomes

  1. OS (Overall survival)

    From the date Into this study (signed ICF) to death for any reason.

    Time frame: From the date Into this study (signed ICF) to death for any reason，assessed up to 60 months.

  2. DCR (Disease control rate)

    The rate of CR, PR plus SD

    Time frame: From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months.

  3. ORR (Objective control rate)

    The rate of CR and PR

    Time frame: From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months.

Other outcomes

  1. AE (Adverse events)

    AE is classified and graded by Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0).

    Time frame: From the date Into this study (signed ICF) to 30 days after tumor progression, 30days after exit this research, or death，whichever came first, assessed up to 36 months.

  2. SAE (Severe adverse events)

    SAE is classified and graded by Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0).

    Time frame: From the date Into this study (signed ICF) to 30 days after tumor progression, 30days after exit this research, or death，whichever came first, assessed up to 36 months.

  3. QOL scores

    Quality of life scores

    Time frame: From the date Into this study (signed ICF) to tumor progression, exit this research, or death，whichever came first, assessed up to 36 months.

06

Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing 100142, China
    Recruiting
07

References and documents

Publications

  • Didkowska J, Wojciechowska U, Manczuk M, Lobaszewski J. Lung cancer epidemiology: contemporary and future challenges worldwide. Ann Transl Med. 2016 Apr;4(8):150. doi: 10.21037/atm.2016.03.11. PubMed 27195268 ↗
  • Hall RD, Le TM, Haggstrom DE, Gentzler RD. Angiogenesis inhibition as a therapeutic strategy in non-small cell lung cancer (NSCLC). Transl Lung Cancer Res. 2015 Oct;4(5):515-23. doi: 10.3978/j.issn.2218-6751.2015.06.09. PubMed 26629420 ↗
  • Zhang H. Apatinib for molecular targeted therapy in tumor. Drug Des Devel Ther. 2015 Nov 13;9:6075-81. doi: 10.2147/DDDT.S97235. eCollection 2015. PubMed 26622168 ↗
  • Fontanella C, Ongaro E, Bolzonello S, Guardascione M, Fasola G, Aprile G. Clinical advances in the development of novel VEGFR2 inhibitors. Ann Transl Med. 2014 Dec;2(12):123. doi: 10.3978/j.issn.2305-5839.2014.08.14. PubMed 25568876 ↗
  • Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16. PubMed 26884585 ↗
  • Zhang L, Shi M, Huang C et al. A phase II, multicenter, placebo-controlled trial of apatinib in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) after two previous treatment regimens. J Clin Oncol 2012; 30: Abst 7548.
  • 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 ↗
  • Ding L, Li QJ, You KY, Jiang ZM, Yao HR. The Use of Apatinib in Treating Nonsmall-Cell Lung Cancer: Case Report and Review of Literature. Medicine (Baltimore). 2016 May;95(20):e3598. doi: 10.1097/MD.0000000000003598. PubMed 27196461 ↗
  • Fan M, Zhang J, Wang Z, Wang B, Zhang Q, Zheng C, Li T, Ni C, Wu Z, Shao Z, Hu X. Phosphorylated VEGFR2 and hypertension: potential biomarkers to indicate VEGF-dependency of advanced breast cancer in anti-angiogenic therapy. Breast Cancer Res Treat. 2014 Jan;143(1):141-51. doi: 10.1007/s10549-013-2793-6. Epub 2013 Dec 1. PubMed 24292957 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03376191
Lead sponsor
Jian Fang
Collaborators
The Second Affiliated Hospital of Harbin Medical University, Peking University Third Hospital, Peking University First Hospital
Responsible party
Jian Fang (professor, Peking University Cancer Hospital & Institute) — Sponsor-investigator
First posted
Dec 18, 2017
Start date
May 1, 2017
Primary completion
Apr 1, 2019 (estimated)
Completion
Oct 1, 2019 (estimated)
Last update
Dec 18, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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