Apatinib in Advanced Non-squamous，NSCLC

Non-squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

Prospective, Multicenter, Non-intervention Clinical Trial of Apatinib in the Treatment of Advanced Non-squamous，Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03376191
• Other study ID #: APTN-NIS-NSCLC-BCH
• Status: Recruiting
• Phase: N/A
• First received: December 7, 2017
• Last updated: December 12, 2017
• Start date: May 1, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: December 2017
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• apatinib
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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Jian Fang	Peking University First Hospital, Peking University Third Hospital, The Second Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

References & 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AE (Adverse events)	AE is classified and graded by Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0).	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.
Other	SAE (Severe adverse events)	SAE is classified and graded by Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0).	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.
Other	QOL scores	Quality of life 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.
Primary	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	OS (Overall survival)	From the date Into this study (signed ICF) to death for any reason.	From the date Into this study (signed ICF) to death for any reason,assessed up to 60 months.
Secondary	DCR (Disease control rate)	The rate of CR, PR plus SD	From the date Into this study (signed ICF) to tumor progression,assessed up to 36 months.
Secondary	ORR (Objective control rate)	The rate of CR and PR	From the date Into this study (signed ICF) to tumor progression,assessed up to 36 months.