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Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer

Primary Purpose

Nonsmall Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib combined with pemetrexed
Sponsored by
Wuling Ou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonsmall Cell Lung Cancer focused on measuring apatinib, pemetrexed, NSCLC

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged from 18 years to 70years.
  2. Histologically or cytologically confirmed non-squamous non-small cell lung cancer(stage IIIB/IV).
  3. Measurable lesions as defined by RECIST criteria.
  4. Locally advanced lung cancer cannot treat with surgery, recurrent or metastatic lung cancer
  5. ECOG performance status (PS) of 0 to 1.
  6. Life expectancy ≥3 months.
  7. Informed consent.

Exclusion Criteria:

  1. Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.
  2. Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
  3. Tumor invade big vessels or close to big vessels (less than 5mm)
  4. Obvious cavity or necrosis formed in the tumor
  5. Uncontrolled hypertension
  6. Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
  7. Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy
  8. The active HBV or HCV infection
  9. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.
  10. Hemoptysis, more than 2.5ml daily
  11. Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
  12. Unhealed bone fracture or wound for long time
  13. Received big surgery, had bone fracture or ulcer in 4 weeks.
  14. Urine protein≥++, or urine protein in 24 hours≥1.0g
  15. Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment
  16. Have received prior treatment with VEGFR TKI (Bevacizumab is permitted).
  17. Pregnant or lactating woman, or woman unwilling to practice contraception during the study.

Sites / Locations

  • Ou wulingRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

apatinib

Arm Description

combined with pemetrexed

Outcomes

Primary Outcome Measures

progression free survival
evaluation per 28 days

Secondary Outcome Measures

Overall Survival
evaluation per 28 days
disease control rate
evaluation per 28 days
objective response rate
evaluation per 28 days
Adverse Event
evaluation per 28 days

Full Information

First Posted
November 21, 2016
Last Updated
February 15, 2017
Sponsor
Wuling Ou
Collaborators
Jiangsu HengRui Medicine Co., Ltd., Hubei Clinical Research Collaboration Group
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1. Study Identification

Unique Protocol Identification Number
NCT02974933
Brief Title
Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer
Official Title
Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer ：Single Arm Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wuling Ou
Collaborators
Jiangsu HengRui Medicine Co., Ltd., Hubei Clinical Research Collaboration Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of apatinib mesylate combined with pemetrexed alone in advanced non-small cell lung cancer patients in the second or second line of treatment of progression-free survival
Detailed Description
It is a one-arm study. The progression-free survival will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsmall Cell Lung Cancer
Keywords
apatinib, pemetrexed, NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
apatinib
Arm Type
Experimental
Arm Description
combined with pemetrexed
Intervention Type
Drug
Intervention Name(s)
Apatinib combined with pemetrexed
Intervention Description
For those pretreated non-squamous non-small cell lung cancer, treat with apatinib 500mg Qd, po.combined with pemetrexed continue until disease progression
Primary Outcome Measure Information:
Title
progression free survival
Description
evaluation per 28 days
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Overall Survival
Description
evaluation per 28 days
Time Frame
4 weeks
Title
disease control rate
Description
evaluation per 28 days
Time Frame
4 weeks
Title
objective response rate
Description
evaluation per 28 days
Time Frame
4 weeks
Title
Adverse Event
Description
evaluation per 28 days
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged from 18 years to 70years. Histologically or cytologically confirmed non-squamous non-small cell lung cancer(stage IIIB/IV). Measurable lesions as defined by RECIST criteria. Locally advanced lung cancer cannot treat with surgery, recurrent or metastatic lung cancer ECOG performance status (PS) of 0 to 1. Life expectancy ≥3 months. Informed consent. Exclusion Criteria: Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer. Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation. Tumor invade big vessels or close to big vessels (less than 5mm) Obvious cavity or necrosis formed in the tumor Uncontrolled hypertension Myocardial ischemia or infarction more than stage II, cardiac insufficiency. Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy The active HBV or HCV infection History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix. Hemoptysis, more than 2.5ml daily Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis. Unhealed bone fracture or wound for long time Received big surgery, had bone fracture or ulcer in 4 weeks. Urine protein≥++, or urine protein in 24 hours≥1.0g Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment Have received prior treatment with VEGFR TKI (Bevacizumab is permitted). Pregnant or lactating woman, or woman unwilling to practice contraception during the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ou Wu Ling, MD
Email
609700817@qq.com
Facility Information:
Facility Name
Ou wuling
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ou Wu ling, 40
Phone
13469989766
Ext
86
Email
609700817@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer

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