Apatinib in Combination With Docetaxel for Patients With Advanced NSCLC

Lung Cancer Clinical Trial

Official title:

Clinical Study of Apatinib in Combination With Docetaxel for Patients With Advanced NSCLC After Failure of Platinum-based Double-drug Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03411967
• Other study ID #: APTN-L201712
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 21, 2018
• Last updated: January 25, 2018
• Start date: February 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2018
• Source: Zigong No.1 Peoples Hospital
• Contact: Jun Yan, M.D.
• Phone: 868132100694
• Email: 13210069400[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In order to explore a new treatment strategy for patients with failed NSCLC platinum-containing double-drug therapy, this study was to investigate the clinical efficacy of apatinib in combination with docetaxel for patients with advanced NSCLC after failure of platinum-based regime

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. ECOG 0-2;

2. Expected survival of not less than 12 weeks;

3. The first line of platinum-containing chemotherapy, pathologically confirmed IIIB, IV non-small cell lung cancer, with measurable lesions (according to the RECIST 1.1 standard, CT lesion tumor diameter = 10mm, lymph node lesion CT scan diameter = 15mm, measurable lesions have not received radiotherapy, local treatment such as freezing)

4. The main organs function properly

5. Women of childbearing age must have had reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and are willing to take appropriate measures 8 weeks after and during the last administration of the test drug contraception. In the case of males, consent is to be given to contraception or surgical sterilization 8 weeks after and during the last administration of the test drug;

6. Participants volunteered to join the study and signed informed consent form, with good compliance and follow-up.

Exclusion Criteria:

1. Imaging (CT or MRI) showed tumor lesions away from the large blood vessels = 5mm, or the presence of invasive central local blood vessels of the central tumor; or showed the presence of significant lung empty or necrotic tumors;

2. Uncontrolled hypertension (systolic BP =140 mmHg or diastolic BP =90 mmHg, despite optimal drug therapy);

3. Has the following cardiovascular disease: Myocardial ischemia or myocardial infarction with grade II or higher, poorly controlled arrhythmia (including QTc intercourse men = 450ms, women = 470ms); NYHA class III-IV cardiomyopathy, Or cardiac ultrasound examination prompted left ventricular ejection fraction (LVEF) <50%;

4. Hemoptysis (INR> 1.5 or Prothrombin Time (PT)> ULN + 4 seconds or APTT> 1.5ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;

5. In the first 2 months before enrollment, there is obvious slightly blood, or daily hemoptysis volume of 2.5ml or more;

6. Within 3 months prior to enrollment, significant clinically significant bleeding symptoms or definite bleeding tendencies such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ at baseline, and above, or vasculitis;

7. Incidence of arterial / venous thrombosis within the first 12 months of enrollment such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;

8. Known hereditary or acquired bleeding and thrombophilia (eg hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc);

9. Factors that significantly affect the absorption of oral drugs, such as non-swallowing, chronic diarrhea and intestinal obstruction;

10. Urine routine urinary protein = ++, or confirmed 24-hour urinary protein content = 2.0g;

11. Previous or concurrent with other unhealed malignancies, except for those having had a cure for cutaneous basal cell carcinoma, carcinoma of the cervix, and superficial bladder cancer;

12. Pregnant or lactating women; Reproductive patients who are unwilling or unable to take effective contraception;

13. The investigators determine other situations that may affect clinical research and outcome decisions.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Drug:
• Apatinib
apatinib mesylate tablets 500mg, po, qd, continued until the next cycle, taking on an empty stomach (daily taken at the same time), every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment, apatinib has been taken until the disease progresses, intolerable toxicity.
• Docetaxel
Docetaxel, 60 mg / m2, d1, iv ,every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Zigong No.1 Peoples Hospital	Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective Response Rate	6 month
Secondary	PFS	Progress-Free Survival	12 month