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

Nonsmall Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02974933
• Other study ID #: HubeiCH
• Status: Recruiting
• Phase: Phase 2
• First received: November 21, 2016
• Last updated: February 15, 2017
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: February 2017
• Source: Hubei Cancer Hospital
• Contact: Ou Wu Ling, MD
• Email: 609700817[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

It is a one-arm study. The progression-free survival will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Nonsmall Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	Ou wuling	Wuhan	Hubei

Sponsors (3)

Lead Sponsor	Collaborator
Wuling Ou	Hubei Clinical Research Collaboration Group, Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	evaluation per 28 days	4 weeks
Secondary	Overall Survival	evaluation per 28 days	4 weeks
Secondary	disease control rate	evaluation per 28 days	4 weeks
Secondary	objective response rate	evaluation per 28 days	4 weeks
Secondary	Adverse Event	evaluation per 28 days	4 weeks