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

Study Overview
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Brief Summary
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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
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It is a one-arm study. The progression-free survival will be evaluated.

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

Conditions
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Nonsmall Cell Lung Cancer

Intervention / Treatment
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* Drug: Apatinib combined with pemetrexed


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: apatinib<br>combined with pemetrexed | Drug: Apatinib combined with pemetrexed<br>* For those pretreated non-squamous non-small cell lung cancer, treat with apatinib 500mg Qd, po.combined with pemetrexed continue until disease progression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | evaluation per 28 days | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | evaluation per 28 days | 4 weeks | 
| disease control rate | evaluation per 28 days | 4 weeks | 
| objective response rate | evaluation per 28 days | 4 weeks | 
| Adverse Event | evaluation per 28 days | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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apatinib, pemetrexed, NSCLC