Apatinib in Advanced Non-squamous,NSCLC

December 12, 2017 updated by: Jian Fang

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

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

Study Overview

Status

Unknown

Intervention / Treatment

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date Into this study (signed ICF) to death for any reason,assessed up to 60 months.
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
From the date Into this study (signed ICF) to tumor progression,assessed up to 36 months.
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
From the date Into this study (signed ICF) to tumor progression,assessed up to 36 months.

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

December 18, 2017

Last Update Submitted That Met QC Criteria

December 12, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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