Trial | NCT02974933  Report issue

Title

Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer
Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer ：Single Arm Exploratory Study

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    48
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
It is a one-arm study. The progression-free survival will be evaluated.
Study Started
Nov 30
2016
Primary Completion
Nov 30
2017
Anticipated
Study Completion
Nov 30
2018
Anticipated
Last Update
Feb 17
2017

Drug Apatinib combined with pemetrexed

For those pretreated non-squamous non-small cell lung cancer, treat with apatinib 500mg Qd, po.combined with pemetrexed continue until disease progression

apatinib Experimental

combined with pemetrexed

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.
No Results Posted