Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT02974933 |
Recruitment Status : Unknown
Verified February 2017 by Wuling Ou, Hubei Cancer Hospital.
Recruitment status was: Recruiting
First Posted : November 29, 2016
Last Update Posted : February 17, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nonsmall Cell Lung Cancer | Drug: Apatinib combined with pemetrexed | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 48 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer :Single Arm Exploratory Study |
Actual Study Start Date : | November 2016 |
Estimated Primary Completion Date : | November 2017 |
Estimated Study Completion Date : | November 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: apatinib
combined with pemetrexed
|
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 |
- progression free survival [ Time Frame: 4 weeks ]evaluation per 28 days
- Overall Survival [ Time Frame: 4 weeks ]evaluation per 28 days
- disease control rate [ Time Frame: 4 weeks ]evaluation per 28 days
- objective response rate [ Time Frame: 4 weeks ]evaluation per 28 days
- Adverse Event [ Time Frame: 4 weeks ]evaluation per 28 days

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT02974933
Contact: Ou Wu Ling, MD | 609700817@qq.com |
China, Hubei | |
Ou wuling | Recruiting |
Wuhan, Hubei, China, 430079 | |
Contact: Ou Wu ling, 40 13469989766 ext 86 609700817@qq.com |
Responsible Party: | Wuling Ou, Deputy Chief Physician, Hubei Cancer Hospital |
ClinicalTrials.gov Identifier: | NCT02974933 |
Other Study ID Numbers: |
HubeiCH |
First Posted: | November 29, 2016 Key Record Dates |
Last Update Posted: | February 17, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
apatinib pemetrexed NSCLC |
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 Pemetrexed Apatinib Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors |