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

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

Study Overview

• Status: Unknown
• Conditions: Nonsmall Cell Lung Cancer
• Intervention / Treatment: Drug: Apatinib combined with pemetrexed

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Recruiting
      • Ou wuling
      • Contact: Ou Wu ling, 40; Phone Number: 86 13469989766; Email: 609700817@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wuling Ou
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.; Hubei Clinical Research Collaboration Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ANTICIPATED): November 1, 2017
• Study Completion (ANTICIPATED): November 1, 2018

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (ESTIMATE): November 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: NSCLC; apatinib; pemetrexed
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Folic Acid Antagonists; Pemetrexed; Apatinib
• Other Study ID Numbers: HubeiCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No