Apatinib in Advanced Non-squamous，NSCLC

NCT03376191 | Unknown

• 1 other identifier: APTN-NIS-NSCLC-BCH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-squamous Non-Small Cell Lung Cancer

Keywords

Apatinib; lung cancer; angiogenesis inhibitors; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• PFS (Progression-Free survival)

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

  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 (3)

• OS (Overall survival)

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

• DCR (Disease control rate)

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

• ORR (Objective control rate)

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

Other Outcomes (3)

• AE (Adverse events)

  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.

• SAE (Severe adverse events)

  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.

• QOL scores

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

Interventions

apatinib DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age: ≥ 18 years old;
• Histologically or cytologically confirmed, locally advanced or stage IV non-squamous, non-small cell lung cancer;
• 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;
• The patient is voluntarily to join the study, and signed informed consent, good compliance, with follow-up.

You may not qualify if:

• If any of the following criteria is met, the subject shall be excluded:
• Squamous cell carcinoma and/or small cell lung cancer patients;
• 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.);
• Allergic to apatinib and / or its excipients;
• Pregnant or lactating women;
• 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.

Sponsors & Collaborators

• Jian Fang: lead
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• Peking University Third Hospital: collaborator
• Peking University First Hospital: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 27195268 BACKGROUND

• 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.

  PMID: 26629420 BACKGROUND

• 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.

  PMID: 26622168 BACKGROUND

• 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.

  PMID: 25568876 BACKGROUND

• 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.

  PMID: 26884585 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 20876799 BACKGROUND

• 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.

  PMID: 27196461 BACKGROUND

• 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.

  PMID: 24292957 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 18, 2017
• Study Start: May 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 18, 2017

Record last verified: 2017-12

Locations

CN (1)