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Apatinib in Advanced Non-squamous,NSCLC

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ClinicalTrials.gov Identifier: NCT03376191
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborators:
The Second Affiliated Hospital of Harbin Medical University
Peking University Third Hospital
Peking University First Hospital
Information provided by (Responsible Party):
Jian Fang, Beijing Cancer Hospital

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

Condition or disease Intervention/treatment
Non-squamous Non-Small Cell Lung Cancer Drug: apatinib

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).


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Multicenter, Non-intervention Clinical Trial of Apatinib in the Treatment of Advanced Non-squamous,Non-small Cell Lung Cancer
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. PFS (Progression-Free survival) [ 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 ]
    From the date Into this study (signed ICF) to tumor progression or death for any reason.


Secondary Outcome Measures :
  1. OS (Overall survival) [ Time Frame: From the date Into this study (signed ICF) to death for any reason,assessed up to 60 months. ]
    From the date Into this study (signed ICF) to death for any reason.

  2. DCR (Disease control rate) [ Time Frame: From the date Into this study (signed ICF) to tumor progression,assessed up to 36 months. ]
    The rate of CR, PR plus SD

  3. ORR (Objective control rate) [ Time Frame: From the date Into this study (signed ICF) to tumor progression,assessed up to 36 months. ]
    The rate of CR and PR


Other Outcome Measures:
  1. AE (Adverse events) [ 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. ]
    AE is classified and graded by Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0).

  2. SAE (Severe adverse events) [ 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. ]
    SAE is classified and graded by Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0).

  3. QOL 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. ]
    Quality of life scores



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Local advanced or advanced non-squamous non-small cell lung cancer patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376191


Locations
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Jian Fang    +86-010-88196459    bcht2_mj@163.com   
Contact: Di Wu    +86-010-88196459    lucia8810@sina.com   
Sponsors and Collaborators
Jian Fang
The Second Affiliated Hospital of Harbin Medical University
Peking University Third Hospital
Peking University First Hospital

Publications:
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.

Responsible Party: Jian Fang, professor, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT03376191     History of Changes
Other Study ID Numbers: APTN-NIS-NSCLC-BCH
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jian Fang, Beijing Cancer Hospital:
Apatinib
lung cancer
angiogenesis inhibitors
efficacy
safety

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms